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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05174013
Registration number
NCT05174013
Ethics application status
Date submitted
22/12/2021
Date registered
30/12/2021
Date last updated
22/06/2023
Titles & IDs
Public title
Safety, Tolerability, Pharmacokinetics and Target Engagement of GSK3858279 in Healthy Caucasian, Chinese and Japanese Participants
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Scientific title
A Randomised, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, Target Engagement and Immunogenicity of a Single Subcutaneous Dose of GSK3858279 Administered to Healthy Caucasian, Chinese and Japanese Participants
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Secondary ID [1]
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212979
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pain
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - GSK3858279
Treatment: Drugs - Placebo
Experimental: Participants receiving GSK3858279 -
Placebo Comparator: Participants receiving placebo -
Treatment: Drugs: GSK3858279
GSK3858279 will be administered
Treatment: Drugs: Placebo
Placebo will be administered
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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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Number of participants with adverse events (AEs), serious AE(SAE) and withdrawals due to AEs
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Assessment method [1]
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Timepoint [1]
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Up to 173 days
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Primary outcome [2]
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Change from Baseline in hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and platelet count (Giga cells per liter)
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Assessment method [2]
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Timepoint [2]
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Baseline and up to 173 days
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Primary outcome [3]
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Change from Baseline in hematology Parameter: Red blood cell count (RBC) (Trillion cells per liter)
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Assessment method [3]
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Timepoint [3]
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Baseline and up to 173 days
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Primary outcome [4]
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Change from Baseline in hematology Parameter: Hemoglobin (Grams per Liter)
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Assessment method [4]
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Timepoint [4]
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Baseline and up to 173 days
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Primary outcome [5]
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Change from Baseline in hematology Parameter: Hematocrit (Proportion of red blood cells in blood
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Assessment method [5]
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Timepoint [5]
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Baseline and up to 173 days
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Primary outcome [6]
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Change from Baseline in hematology Parameter: RBC indices (Millions per cubic millimeter)
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Assessment method [6]
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Timepoint [6]
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Baseline and up to 173 days
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Primary outcome [7]
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Change from Baseline in hematology Parameter: Mean Corpuscular Volume (MCV) (Femtoliters)
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Assessment method [7]
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Timepoint [7]
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Baseline and up to 173 days
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Primary outcome [8]
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Change from Baseline in hematology Parameter: Mean corpuscular hemoglobin (MCH) (picograms)
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Assessment method [8]
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Timepoint [8]
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Baseline and up to 173 days
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Primary outcome [9]
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Change from Baseline in hematology Parameter: Reticulocytes (Percentage of reticulocytes)
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Assessment method [9]
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Timepoint [9]
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Baseline and up to 173 days
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Primary outcome [10]
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Change from Baseline in clinical chemistry parameters: Alanine Amino Transferase (ALT),Alkaline Phosphatase (ALP),Aspartate Amino Transferase (AST) (International units per Liter)
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Assessment method [10]
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Timepoint [10]
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Baseline and up to 173 days
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Primary outcome [11]
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Change from Baseline in clinical chemistry parameters: Calcium, glucose (non-fasting), potassium, sodium,urea (Millimoles per Liter)
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Assessment method [11]
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Timepoint [11]
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Baseline and up to 173 days
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Primary outcome [12]
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Change from Baseline in clinical chemistry parameters: Creatinine, direct bilirubin, total bilirubin (Micromoles per liter)
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Assessment method [12]
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Timepoint [12]
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Baseline and up to 173 days
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Primary outcome [13]
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Change from Baseline in clinical chemistry parameters: Total protein (Grams per liter)
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Assessment method [13]
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Timepoint [13]
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Baseline and up to 173 days
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Primary outcome [14]
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Change from Baseline in Urinalysis parameter: Urine Specific Gravity (Ratio of urine density to water density)
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Assessment method [14]
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Timepoint [14]
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Baseline and up to 173 days
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Primary outcome [15]
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Change from Baseline in Urinalysis parameter: Urine Potential of Hydrogen (pH)
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Assessment method [15]
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Timepoint [15]
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Baseline and up to 173 days
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Primary outcome [16]
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Number of Participants With Abnormal Urinalysis Results by Dipstick Method
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Assessment method [16]
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Timepoint [16]
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Up to 173 days
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Primary outcome [17]
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Change from Baseline in vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) (Millimeters of mercury)
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Assessment method [17]
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Timepoint [17]
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Baseline and up to 173 days
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Primary outcome [18]
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Change from Baseline in vital sign : Pulse rate (Beats per minute)
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Assessment method [18]
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Timepoint [18]
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Baseline and up to 173 days
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Primary outcome [19]
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Change from Baseline in vital signs: Body temperature ( Degrees Celsius)
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Assessment method [19]
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Timepoint [19]
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Baseline and up to 173 days
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Primary outcome [20]
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Change from Baseline in vital signs: Respiratory rate (Breaths per minute)
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Assessment method [20]
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Timepoint [20]
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Baseline and up to 173 days
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Primary outcome [21]
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Change from Baseline in vital signs:Heart Rate (Beats per minute)
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Assessment method [21]
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Timepoint [21]
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Baseline and up to 173 days
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Primary outcome [22]
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Change from Baseline in Electrocardiogram (ECG) parameters: PR Interval, QRS Duration, QT Interval and QT interval corrected for heart rate according Fridericia's formula (QTcF) Interval (Milliseconds)
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Assessment method [22]
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Timepoint [22]
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Baseline and up to 173 days
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Primary outcome [23]
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Area Under the plasma Concentration-Time Curve from Time zero to 56 Days [AUC(0-56)] of GSK3858279
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Assessment method [23]
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Timepoint [23]
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Upto 56 days
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Primary outcome [24]
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AUC from Time zero to the last measurable concentration (0-t) post-dose of GSK3858279
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Assessment method [24]
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Timepoint [24]
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Up to 173 days
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Primary outcome [25]
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Time of occurrence of last quantifiable concentration (tlast) of GSK3858279
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Assessment method [25]
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Timepoint [25]
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Up to 173 days
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Primary outcome [26]
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Maximum observed concentration (Cmax) of GSK3858279
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Assessment method [26]
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Timepoint [26]
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Up to 173 days
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Primary outcome [27]
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Time of occurrence of Cmax (tmax) of GSK3858279
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Assessment method [27]
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Timepoint [27]
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Up to 173 days
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Secondary outcome [1]
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Percent change from Baseline in free CCL17
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Assessment method [1]
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Timepoint [1]
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Baseline and at Days 7, 14, 28 and 56
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Secondary outcome [2]
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Cmax of total CCL17 in serum following GSK3858279
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Assessment method [2]
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Timepoint [2]
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Baseline and at Days 7, 14, 28 and 56
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Secondary outcome [3]
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tmax of total CCL17 in serum following GSK3858279
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Assessment method [3]
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Timepoint [3]
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Baseline and at Days 7, 14, 28 and 56
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Secondary outcome [4]
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Number of participants with indicated fold increase in total CCL17 in serum following GSK3858279
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Assessment method [4]
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Timepoint [4]
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Baseline and at Days 7, 14, 28 and 56
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Secondary outcome [5]
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Number of participants with pre-existing anti-drug antibodies (ADAs)
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Assessment method [5]
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Timepoint [5]
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Up to 173 days
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Secondary outcome [6]
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Number of participants with treatment-emergent ADAs over time
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Assessment method [6]
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Timepoint [6]
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Up to 173 days
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Eligibility
Key inclusion criteria
- Participants between 20 and 65 years of age inclusive, at the time of signing the
informed consent.
- Volunteers who are overtly healthy as determined by medical evaluation including
medical history, physical examination, laboratory tests, and cardiac monitoring.
- Participant capable of giving signed informed consent which includes compliance with
the requirements and restrictions listed in the informed consent form (ICF) and in
this protocol.
- Participants who have evidence of completed vaccination for Severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2) with an approved vaccine.
- Body weight within the range 45 - 100 killogram (kg) and body mass index (BMI) within
the range 18-29.9 kg per meter square (/m2) (inclusive).
- Japanese participants are eligible based on meeting all of the following:
- Participants born in Japan
- Descendants of four ethnic Japanese grandparents and two ethnic Japanese parents.
- Have lived outside Japan for less than (<) 10 years at the time of screening
- Chinese participants are eligible based on meeting all of the following
- Participants born in mainland China, Hong Kong or Taiwan
- Descendants of four Chinese grandparents and two Chinese parents
- Have lived outside China, Hong Kong or Taiwan for <10 years at the time of screening
- Caucasian participants are eligible based on meeting the following
- Declaration of familial Caucasian/European ancestry (having 2 parents of
Caucasian/European ancestry and 4 grandparents of Caucasian/European ancestry)
- Male or female participant
- Male participants are eligible to participate if they agree to the following for at
least 28 weeks after the dose of study intervention: Refrain from donating sperm plus
either be abstinent from heterosexual intercourse as their preferred and usual
lifestyle (abstinent on a long term and persistent basis) and agree to remain
abstinent OR must agree to use contraception/barrier as detailed below: agree to use a
male condom and should also be advised of the benefit for a female partner to use a
highly effective method of contraception as a condom may break or leak when having
sexual intercourse with a woman of childbearing potential who is not currently
pregnant.
- A female participant is eligible to participate if she is of non-reproductive
potential.
- Capable of giving signed informed consent.
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Minimum age
20
Years
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Maximum age
65
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
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal,
endocrine, haematological, or neurological disorders capable of significantly altering
the absorption, metabolism, or elimination of drugs; constituting a risk when taking
the study intervention; or interfering with the interpretation of data.
- Personal or family history of cardiomyopathy.
- Abnormal blood pressure at screening as determined by the investigator.
- History of symptomatic herpes zoster.
- Evidence of active or latent tuberculosis (TB) as documented by medical history,
examination, and TB testing with a positive (not indeterminate) QuantiFERON test.
- Significant allergies to humanized monoclonal antibodies as per principal
investigator's and GSK medical monitor's judgements.
- History or evidence of clinically significant multiple or severe drug allergies,
intolerance to topical corticosteroids, or severe post-treatment hypersensitivity
reactions (including, but not limited to, erythema multiforme major, linear
immunoglobulin A (IgA) dermatosis, toxic epidermal necrolysis, and exfoliative
dermatitis).
- History of lymphoma, leukaemia, or any malignancy within the last 5 years except for
basal cell or squamous epithelial carcinomas of the skin that have been resected with
no evidence of metastatic disease for 3 years.
ALT greater than (>)1.5 times upper limit of normal (ULN) .
- Bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin
is fractionated and direct bilirubin <35 percent [%]).
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities
(with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Corrected QT (QTc) >450 milliseconds (msec).
- History of Stevens Johnson Syndrome.
- Known immunodeficiency.
- Participants with a chronic infection (for example [e.g.], osteomyelitis), who have
been receiving treatment within three months prior to dosing or individuals with an
active infection.
- Previous or current history of bleeding diathesis, excessive bleeding or coagulation
disorders.
- History of significant medical illness in the opinion of the investigator would
interfere with the study procedures and / or assessments.
- Intended use of over-the-counter or prescription medication including herbal
medications within 7 days prior to dosing until final follow-up visit.
- Live vaccine(s) or plans to receive such vaccines within 1 month of screening until
final follow-up visit.
- Treatment with biologic agents (such as monoclonal antibodies including marketed
drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.
- Treatment with antiplatelet or anticoagulant agents within 7 days of dosing.
- Major surgery (as per investigator's judgement) within 3 months prior to dosing.
- Participation in the study would result in loss of blood or blood products in excess
of 500 milliliters (mL) within 3 months.
- Exposure to more than 4 new chemical entities within 12 months prior to the first
dosing day.
- Current enrolment or past participation in any other clinical study involving an
investigational drug intervention within the last 3 months or 5 half-lives (whichever
is longer) of signing the ICF.
- Presence of Hepatitis B surface antigen (HBsAg) at screening.
- Presence of the Hepatitis B core antibody (HBcAb) at screening.
- Positive Hepatitis C antibody test result at screening.
- Positive Hepatitis C Ribonucleic acid (RNA) test result at screening or within 3
months prior to first dose of study intervention.
- Abnormal clinically significant echocardiogram at screening, as assessed by the
investigator.
- Cardiac troponin or N-terminal pro B-type natriuretic peptide (NT-proBNP) levels out
of normal range at screening.
- Positive pre-study drug/alcohol screen.
- Positive human immunodeficiency virus (HIV) antibody test.
- Positive coronavirus disease 2019 (COVID-19): SARS-CoV2 polymerase chain reaction
(PCR) or lateral flow test of a combined throat and nasopharyngeal swab or nasal swab
only.
- Regular alcohol consumption within 6 months prior to the study defined as: an average
weekly intake of >14 units for males and >14 units for females. One unit is equivalent
to 8 grams of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass (125 mL) of
wine or 1 (25 mL) measure of spirits.
- Regular use of known drugs of abuse.
- Sensitivity to any of the study interventions, or components thereof, or drug or other
allergy that, in the opinion of the investigator or medical monitor, contraindicates
participation in the study.
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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
The people analysing the results/data
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Intervention assignment
Other
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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
14/02/2022
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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
2/06/2023
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Sample size
Target
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Accrual to date
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Final
32
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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GSK Investigational Site - Herston
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Recruitment hospital [2]
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GSK Investigational Site - Melbourne
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Recruitment postcode(s) [1]
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4006 - Herston
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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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
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK),
target engagement (TE) and immunogenicity of GSK3858279 when administered to healthy
Caucasian, Chinese and Japanese participants.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05174013
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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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GSK Clinical Trials
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Address
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GlaxoSmithKline
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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
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05174013
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