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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03579823
Registration number
NCT03579823
Ethics application status
Date submitted
8/06/2018
Date registered
9/07/2018
Titles & IDs
Public title
Comparative Safety, Tolerability, Pharmacokinetic Study of AVT02 (100MG/ML) and Humira (100MG/ML) in Healthy Volunteers
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Scientific title
Single Centre, Randomised, Single-Blind, Pilot Study to Compare the Safety, Tolerability and Pharmacokinetics of AVT02 to EU-approved Humira® as a Single Dose (40 mg) Subcutaneous Injection in Healthy Adult Subjects (ALVOPAD)
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Secondary ID [1]
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AVT02-GL-100
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Universal Trial Number (UTN)
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Trial acronym
ALVOPAD
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Adalimumab 100 MG/ML [Humira]
Treatment: Drugs - AVT02 100MG/ML
Experimental: AVT02 100 MG/ML - Single subcutaneous injection of 40 mg of AVT02 (100MG/ML)
Active comparator: Adalimumab 100 MG/ML [HUMIRA] - Single subcutaneous injection of 40 mg of Adalimumab (100MG/ML) \[HUMIRA\]
Treatment: Drugs: Adalimumab 100 MG/ML [Humira]
prefilled syringe at a concentration of 100MG/ML and delivering 40MG of adalimumab, as a single dose on day 1 day 1
Treatment: Drugs: AVT02 100MG/ML
prefilled syringe at a concentration of 100MG/ML delivering 40MG of AVT02, as a single dose on day 1 day 1
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change from baseline blood pressure at 1, 2, 3, 4, 5, 6, 7, 8, 9, 64 days post dosing
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Assessment method [1]
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Measurement of blood pressure (systolic and diastolic in mm Hg)
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Timepoint [1]
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Predose and 1, 2, 3, 4, 5, 6, 7, 8, 9, 64 days post dosing
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Primary outcome [2]
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Change from baseline heart rate at 1, 2, 3, 4, 5, 6, 7, 8, 9, 64 days post dosing
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Assessment method [2]
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Measure of heart rate (beats per minute)
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Timepoint [2]
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Predose and 1, 2, 3, 4, 5, 6, 7, 8, 9, 64 days post dosing
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Primary outcome [3]
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Change from baseline body temperature at 1, 2, 3, 4, 5, 6, 7, 8, 9, 64 days post dosing
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Assessment method [3]
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Measurement of oral temperature (Celsius degree)
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Timepoint [3]
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Predose and 1, 2, 3, 4, 5, 6, 7, 8, 9, 64 days post dosing
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Primary outcome [4]
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Change from baseline electrocardiogram at 1, 2, 5, 9, 64 days post dosing
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Assessment method [4]
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Analysis of 12-lead electrocardiogram
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Timepoint [4]
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Predose and 1, 2, 5, 9, 64 days post dosing
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Primary outcome [5]
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Change from baseline red blood cells at 2, 3, 5, 9, 64 days post dosing
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Assessment method [5]
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Blood collection to measure red blood cells count, (unit/mm3)
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Timepoint [5]
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Predose and 2, 3, 5, 9, 64 days post dosing
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Primary outcome [6]
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Change from baseline haemoglobin at 2, 3, 5, 9, 64 days post dosing
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Assessment method [6]
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Blood collection to measure haemoglobin (g/L)
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Timepoint [6]
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Predose and 2, 3, 5, 9, 64 days post dosing
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Primary outcome [7]
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Change from baseline white blood cells at 2, 3, 5, 9, 64 days post dosing
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Assessment method [7]
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Blood collection to measure white blood cells count, (unit/mm3)
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Timepoint [7]
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Predose and 2, 3, 5, 9, 64 days post dosing
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Primary outcome [8]
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Change from baseline platelets at 2, 3, 5, 9, 64 days post dosing
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Assessment method [8]
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Blood collection to measure platelets count, (unit/mm3)
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Timepoint [8]
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Predose and 2, 3, 5, 9, 64 days post dosing
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Primary outcome [9]
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Change from baseline blood gamma glutamyl transferase at 2, 3, 5, 9, 64 days post dosing
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Assessment method [9]
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Blood collection to measure gamma glutamyl transferase (UI/L)
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Timepoint [9]
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Predose and 2, 3, 5, 9, 64 days post dosing
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Primary outcome [10]
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Change from baseline blood aspartate aminotransferase at 2, 3, 5, 9, 64 days post
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Assessment method [10]
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Blood collection to measure aspartate aminotransferase (UI/L)
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Timepoint [10]
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Predose and 2, 3, 5, 9, 64 days post dosing
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Primary outcome [11]
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Change from baseline blood alanine aminotransferase at 2, 3, 5, 9, 64 days post
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Assessment method [11]
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Blood collection to measure alanine aminotransferase (UI/L)
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Timepoint [11]
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Predose and 2, 3, 5, 9, 64 days post dosing
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Primary outcome [12]
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Change from baseline blood potassium at 2, 3, 5, 9, 64 days post dosing
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Assessment method [12]
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Blood collection to measure potassium (mmol/L)
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Timepoint [12]
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Predose and 2, 3, 5, 9, 64 days post dosing
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Primary outcome [13]
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Change from baseline blood sodium at 2, 3, 5, 9, 64 days post dosing
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Assessment method [13]
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Blood collection to measure sodium (mmol/L)
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Timepoint [13]
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Predose and 2, 3, 5, 9, 64 days post dosing
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Primary outcome [14]
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Change from baseline blood calcium at 2, 3, 5, 9, 64 days post dosing
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Assessment method [14]
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Blood collection to measure calcium (mmol/L)
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Timepoint [14]
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Predose and 2, 3, 5, 9, 64 days post dosing
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Primary outcome [15]
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Change from baseline blood phosphate at 2, 3, 5, 9, 64 days post dosing
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Assessment method [15]
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Blood collection to measure phosphate (mmol/L)
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Timepoint [15]
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Predose and 2, 3, 5, 9, 64 days post dosing
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Primary outcome [16]
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Change from baseline blood chloride at 2, 3, 5, 9, 64 days post dosing
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Assessment method [16]
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Blood collection to measure chloride (mmol/L)
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Timepoint [16]
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Predose and 2, 3, 5, 9, 64 days post dosing
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Primary outcome [17]
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Change from baseline blood bicarbonate at 2, 3, 5, 9, 64 days post dosing
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Assessment method [17]
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Blood collection to measure bicarbonate (mmol/L)
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Timepoint [17]
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Predose and 2, 3, 5, 9, 64 days post dosing
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Primary outcome [18]
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Change from baseline blood creatinine at 2, 3, 5, 9, 64 days post dosing
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Assessment method [18]
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Blood collection to measure creatinine (micromol/L)
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Timepoint [18]
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Predose and 2, 3, 5, 9, 64 days post dosing
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Primary outcome [19]
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Change from baseline blood bilirubin at 2, 3, 5, 9, 64 days post dosing
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Assessment method [19]
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Blood collection to measure Bilirubin (micromol/L)
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Timepoint [19]
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Predose and 2, 3, 5, 9, 64 days post dosing
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Primary outcome [20]
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Change from baseline international normalised ratio at 2, 3, 5, 9, 64 days post dosing
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Assessment method [20]
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Blood collection to measure international normalised ratio
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Timepoint [20]
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Predose and 2, 3, 5, 9, 64 days post dosing
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Primary outcome [21]
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Change from baseline prothrombin time at 2, 3, 5, 9, 64 days post dosing
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Assessment method [21]
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Blood collection to measure prothrombin time (sec)
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Timepoint [21]
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Predose and 2, 3, 5, 9, 64 days post dosing
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Primary outcome [22]
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Change from baseline partial prothrombin time at 2, 3, 5, 9, 64 days post dosing
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Assessment method [22]
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Blood collection to measure partial prothrombin time (sec)
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Timepoint [22]
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Predose and 2, 3, 5, 9, 64 days post dosing
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Primary outcome [23]
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Change from baseline activated partial thromboplastin time at 2, 3, 5, 9, 64 days post
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Assessment method [23]
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Blood collection to measure activated partial thromboplastin time (sec)
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Timepoint [23]
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Predose and 2, 3, 5, 9, 64 days post dosing
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Primary outcome [24]
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Change from baseline thrombin time at 2, 3, 5, 9, 64 days post
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Assessment method [24]
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Blood collection to measure thrombin time (sec)
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Timepoint [24]
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Predose and 2, 3, 5, 9, 64 days post dosing
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Primary outcome [25]
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Change from baseline urine leucocytes at 2, 3, 5, 9, 64 days post dosing
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Assessment method [25]
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Urine sample collection to measure leucocytes
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Timepoint [25]
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Predose and 2, 3, 5, 9, 64 days post dosing
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Primary outcome [26]
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Change from baseline urine glucose at 2, 3, 5, 9, 64 days post dosing
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Assessment method [26]
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Urine sample collection to measure glucose
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Timepoint [26]
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Predose and 2, 3, 5, 9, 64 days post dosing
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Primary outcome [27]
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Change from baseline urine protein at 2, 3, 5, 9, 64 days post dosing
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Assessment method [27]
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Urine sample collection to measure protein
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Timepoint [27]
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Predose and 2, 3, 5, 9, 64 days post dosing
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Secondary outcome [1]
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Area under the plasma concentration-time curve (AUC)
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Assessment method [1]
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Venous blood samples will be collected for measurement of Area under the plasma concentration-time curve (AUC) of AVT02 and EU Humira
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Timepoint [1]
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Over 64 days
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Secondary outcome [2]
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Maximum serum concentration
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Assessment method [2]
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Venous blood samples will be collected for measurement of serum concentration of AVT02 and EU Humira
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Timepoint [2]
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Over 64 days
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Secondary outcome [3]
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Time to maximum serum concentration
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Assessment method [3]
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Evaluation of time to maximum plasma concentration (Tmax) of AVT02 and Humira.
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Timepoint [3]
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Over 64 days
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Secondary outcome [4]
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Terminal half-life
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Assessment method [4]
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Evaluation of terminal elimination half-life (T1/2) of AVT02 and Humira
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Timepoint [4]
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Over 64 days
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Secondary outcome [5]
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Volume of distribution
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Assessment method [5]
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Evaluation of volume of distribution during the elimination phase (Vz) of AVT02 and Humira
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Timepoint [5]
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Over 64 days
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Secondary outcome [6]
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Clearance
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Assessment method [6]
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Evaluation of total plasma clearance (CL) of AVT02 and Humira
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Timepoint [6]
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Over 64 days
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Secondary outcome [7]
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Incidence and titer of anti-drug antibodies to adalimumab
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Assessment method [7]
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A blood sample will be collected to measure antibodies to AVT02 and Humira
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Timepoint [7]
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15, 29 and 64 days after dosing
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Eligibility
Key inclusion criteria
Main
* Male and female healthy adult subjects willing to sign an Informed Consent Form and able to undergo protocol related procedures.
* Age: 18 to 55 years, inclusive.
* Body Mass Index (BMI): 19.0 to 30.0 kg per m2.
* Medical history without major pathology, at the discretion of Principal Investigator.
* Resting supine systolic blood pressure of =150 mmHg and diastolic blood pressure of =90 mmHg. Other vital signs showing no clinically relevant deviations according to the Principal Investigator's judgment.
* Computerised 12-lead ECG recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the Principal Investigator.
* Subjects who do not smoke tobacco products or use nicotine replacement therapy or e-cigarettes.
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Evidence of clinically relevant pathology.
* Unable to follow protocol instructions in the opinion of the Principal Investigator.
* History of relevant drug and or food allergies.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study.
* Known history of previous exposure to adalimumab or other anti-TNF-alpha molecules.
* Any past or concurrent medical conditions potentially increasing the subject's risks, or would have interfered with the study evaluation, procedures, or study completion. Examples of these include medical history with evidence of clinically relevant pathology (e.g., malignancies, demyelinating disorders, herpes zoster, or hepatic, gallbladder or pancreatic diseases).
* Presence of chronic obstructive pulmonary disease. Asthma in the childhood is allowed.
* Evidence of a recent, within 6 months, infection requiring hospitalisation or intravenous antibiotic use.
* Subject has a positive test for Tuberculosis (TB) during screening or a known history of active or latent TB, except documented and complete adequate treatment of TB.
* Having received live vaccines during the 4 weeks before screening or have the intention to receive vaccination during the study.
* Positive for Hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HbcAb), anti- Hepatitis C virus antibodies (HCV), or anti-human immunodeficiency virus (HIV) 1 on 2 antibodies at screening.
* Impaired liver function
* Any persons who are an employee of the Principal Investigator, clinical centre, clinical research organisation or Sponsor, a relative of an employee of the clinical centre, the Investigator, Clinical Research Organization (CRO) or the Sponsor.
* Other inclusion/exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/05/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
24/08/2018
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Sample size
Target
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Accrual to date
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Final
24
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Nucleus Network - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Alvotech Swiss AG
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Adalimumab is an immunosuppressive drug that belongs to the family of anti-TNF agents. It contains a monoclonal antibody produced by biotechnology. It is designed to bind to tumor necrosis factor (TNF), a substance that is involved in several auto-immune processes. By binding to TNF, adalimumab blocks its activity, reducing the severity of various chronic inflammatory diseases including Rheumatoid Arthritis, Plaque Psoriasis and others. Often, the high cost of biologic products may preclude access to the treatment to a big portion of the population worldwide. A biosimilar product that provides comparable safety and efficacy at more affordable cost would fulfill a broader medical need. Humira has been available on the market for several years. Recently, a higher concentration (100 mg/mL) formulation has been introduced in major markets. Alvotech is developing AVT02, that is a proposed biosimilar of adalimumab containing high concentration (100 mg/mL) of active ingredient. The objective of this clinical trial is to assess the similarity of AVT02 (100 mg/mL) with Humira (100 mg/mL), in terms of tolerability, safety (including immunogenicity) and compare the pharmacokinetics in healthy volunteers.
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Trial website
https://clinicaltrials.gov/study/NCT03579823
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03579823