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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/NCT05937581
Registration number
NCT05937581
Ethics application status
Date submitted
18/05/2023
Date registered
10/07/2023
Date last updated
9/05/2024
Titles & IDs
Public title
First-In-Human Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Escalating Single And Multiple Doses Of CSL040 In Healthy Subjects
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Scientific title
A Phase 1, Double-Blind (Sponsor-Unblinded), Placebo-Controlled, Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Single And Multiple Doses Of CSL040 In Healthy Adult Subjects
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Secondary ID [1]
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CSL040_1001
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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:
Complement Deficiencies
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Condition category
Condition code
Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - CSL040
Treatment: Drugs - Placebo
Experimental: Part A (SAD): CSL040 (minimum dose) - Single Intravenous (IV) administration
Experimental: Part A (SAD): CSL040 (lower dose) - Single IV Administration
Experimental: Part A (SAD): CSL040 (low dose) - Single IV Administration
Experimental: Part A (SAD): CSL040 (medium dose) - Single IV Administration
Experimental: Part A (SAD): CSL040 (medium-high dose) - Single IV Administration
Experimental: Part A (SAD): CSL040 (maximum dose) - Single IV Administration
Placebo Comparator: Part A (SAD): Placebo - Single IV Administration
Experimental: Part B (MAD): CSL040 (minimum dose) - IV Administration not to exceed 5 doses over 14 days)
Experimental: Part B (MAD): CSL040 (medium dose) - IV Administration not to exceed 5 doses over 14 days
Experimental: Part B (MAD): CSL040 (high dose) - IV Administration not to exceed 5 doses over 14 days
Placebo Comparator: Part B (MAD): Placebo - IV Administration not go exceed 5 doses over 14 days
Treatment: Drugs: CSL040
IV Administration
Treatment: Drugs: Placebo
0.9% w/v NaCI, IV Administration
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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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Frequency counts for subjects with treatment emergent adverse events (TEAEs) leading to withdrawal or discontinuation of investigational product
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Assessment method [1]
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Timepoint [1]
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Up to 10 weeks
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Primary outcome [2]
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Percentages for subjects with treatment emergent TEAEs leading to withdrawal or discontinuation of investigational product
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Assessment method [2]
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Timepoint [2]
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Up to 10 weeks
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Primary outcome [3]
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Change from Baseline in tympanic temperature
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Assessment method [3]
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0
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Timepoint [3]
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Up to 10 weeks
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Primary outcome [4]
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Change from Baseline in pulse rate
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Assessment method [4]
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Timepoint [4]
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Up to 10 weeks
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Primary outcome [5]
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Change from Baseline in blood pressure
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Assessment method [5]
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Timepoint [5]
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Up to 10 weeks
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Primary outcome [6]
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Change from Baseline in leukocytes (white blood cell count)
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Assessment method [6]
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Timepoint [6]
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Up to 10 weeks
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Primary outcome [7]
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Change from Baseline of hemoglobin values
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Assessment method [7]
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Timepoint [7]
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Up to 10 weeks
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Primary outcome [8]
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Change from Baseline of C-reactive protein (CRP)
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Assessment method [8]
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Timepoint [8]
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Up to 10 weeks
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Primary outcome [9]
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Change from Baseline in Creatinine levels
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Assessment method [9]
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Timepoint [9]
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Up to 10 weeks
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Primary outcome [10]
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Change from Baseline above the upper limit of normal (ULN) for alanine aminotransaminase (ALT)
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Assessment method [10]
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Timepoint [10]
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Up to 10 weeks
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Primary outcome [11]
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Change from Baseline above the upper limit of normal (ULN) for aspartate aminotransaminase (AST)
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Assessment method [11]
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Timepoint [11]
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Up to 10 weeks
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Primary outcome [12]
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Change from Baseline in corrected QT interval using Fridericia's formula (QTcF) values of triplicate electrocardiograms
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Assessment method [12]
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0
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Timepoint [12]
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Up to 10 weeks
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Secondary outcome [1]
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Part A (Single Ascending Dose [SAD]): Maximum concentration (Cmax)
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Assessment method [1]
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Timepoint [1]
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Up to 56 Days
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Secondary outcome [2]
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Part A (SAD): Time to reach maximum concentration (Tmax)
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Assessment method [2]
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Timepoint [2]
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Up to 56 Days
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Secondary outcome [3]
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Part A (SAD): Time to Area under the concentration-time curve from time 0 to the last measurable concentration (AUC0-last)
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Assessment method [3]
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Timepoint [3]
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Up to 56 Days
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Secondary outcome [4]
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Part A (SAD): Area under the concentration-time curve from time 0 to infinity (AUC0-infinity)
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Assessment method [4]
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Timepoint [4]
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Up to 56 Days
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Secondary outcome [5]
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Part A (SAD): Total systemic clearance (CL)
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Assessment method [5]
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Timepoint [5]
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Up to 56 Days
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Secondary outcome [6]
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Part A (SAD): Volume of distribution (V)
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Assessment method [6]
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Timepoint [6]
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Up to 56 Days
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Secondary outcome [7]
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Part A (SAD): Terminal elimination half-life (T1/2)
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Assessment method [7]
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Timepoint [7]
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Up to 56 Days
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Secondary outcome [8]
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Part B (Multiple Ascending Dose [MAD]): Maximum concentration (Cmax)
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Assessment method [8]
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Timepoint [8]
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Up to 70 Days
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Secondary outcome [9]
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Part B (MAD): Time to reach maximum concentration (Tmax)
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Assessment method [9]
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Timepoint [9]
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Up to 70 Days
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Secondary outcome [10]
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Part B (MAD): Time to Area under the concentration-time curve in 1 dosing interval (AUCtau)
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Assessment method [10]
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Timepoint [10]
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Up to 70 Days
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Secondary outcome [11]
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Part B (MAD): Accumulation index (accumulation ratio determined by the ratio of steady state AUCtau to single dose AUCtau
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Assessment method [11]
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Timepoint [11]
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Up to 70 Days
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Secondary outcome [12]
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Part B (MAD): Lowest concentration prior to dosing (Ctrough)
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Assessment method [12]
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Timepoint [12]
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Up to 70 Days
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Secondary outcome [13]
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Part B (MAD): Total systemic clearance (CL)
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Assessment method [13]
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Timepoint [13]
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Up to 70 Days
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Secondary outcome [14]
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Part B (MAD): Volume of distribution at steady state (Vss)
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Assessment method [14]
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Timepoint [14]
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Up to 70 Days
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Secondary outcome [15]
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Part A (SAD) and Part B (MAD): Maximum percent change from Baseline (Emax)
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Assessment method [15]
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Using Percent change from Baseline versus time course profiles of complement activation components
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Timepoint [15]
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Up to 56 Days (Part A) and up to 70 days (Part B)
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Secondary outcome [16]
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Part A (SAD) and Part B (MAD): Time to maximum percent change from Baseline (TEmax)
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Assessment method [16]
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Using Percent change from Baseline versus time course profiles of complement activation components
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Timepoint [16]
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Up to 56 Days (Part A) and up to 70 days (Part B)
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Secondary outcome [17]
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Part A (SAD) and Part B (MAD): Time to return to baseline
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Assessment method [17]
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Using Percent change from Baseline versus time course profiles of complement activation components
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Timepoint [17]
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Up to 56 Days (Part A) and up to 70 days (Part B)
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Secondary outcome [18]
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Part A (SAD) and Part B (MAD): Presence of treatment-emergent antidrug antibodies after administration of CSL040
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Assessment method [18]
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Timepoint [18]
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Up to 56 Days (Part A) and up to 70 days (Part B)
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Eligibility
Key inclusion criteria
1. Male or female 18 to 64 years of age, inclusive, at Screening
2. Body weight in the range of = 50 kg and = 100 kg, with a body mass index of = 18 kg/m2
and = 30 kg/m2, at Screening
3. Judged as healthy by an Investigator after completion of a comprehensive clinical
assessment
4. Capable of providing written informed consent and willing and able to adhere to all
protocol requirements
5. Can understand the nature, scope, and possible consequences of the study and able to
comply with study procedures, restrictions, and requirements
6. Able to provide proof of vaccination against meningococcal disease according to local
requirements or willing to receive meningococcal vaccination aligned with local
guidelines (vaccination with recombinant meningococcal B vaccine against B serogroup
[Men B] and quadrivalent meningococcal conjugate vaccine against A, C, W, and Y
serogroups [Men ACWY]), at least 21 days before the first dose of CSL040
7. Continuous nonsmoker who has not used nicotine- and tobacco-containing products for at
least 30 days prior to the first dosing based on urine cotinine testing at Screening
and Day-1
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Minimum age
18
Years
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Maximum age
64
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
1. Any individual at high risk of exposure to Neisseria meningitidis, including, but not
limited to, health care workers, doctors, nurses, students working in a clinical
setting, laboratory workers with exposure to N. meningitidis, individuals residing in
a dormitory setting (eg, military workers), and childcare workers
2. Other than the required meningococcal vaccines, any live vaccinations within the last
90 days before and during the study and / or up to 90 days after the last
administration of the investigational product
3. A positive test result for hepatitis B surface antigen (HBsAg), hepatitis B core
antigen, hepatitis B surface antibody, hepatitis C virus antibody, or human
immunodeficiency virus-1/2 antibody.
4. History concerning for a N. meningitidis infection
5. History of allergy or intolerance to Penicillin V
6. History of unexplained, recurrent infection, life-threatening infection, or history
that suggests any immunodeficiency (functional immunodeficiency), including asplenia /
functional asplenia
7. Infection requiring treatment with systemic antibiotics (IV and / or oral
administration for more than 3 days) within the last 90 days prior to dosing
8. Clinical evidence of current active serious infection, including any localized
infections, or any infection which makes the participation in this study of healthy
subjects unacceptably high risk
9. Blood pressure or pulse rate measurements outside the normal range for the subject's
age and assessed as clinically significant
10. Known history of severe hypersensitivity reactions or suspected hypersensitivity to
the CSL040 or any of the excipients or other monoclonal antibodies
11. Subject has any condition that may compromise their safety or compliance, impede
successful conduct of the study, interfere with interpretation of the results or would
otherwise render the subject unsuitable for participation in the study
12. A positive test result for drugs of abuse (including alcohol) at Screening and / or
Day -1.
13. Weekly alcohol intake of > 10 units for females and > 14 units for males during the 3
months before Day -1.
14. Any values above the upper limit of normal (ULN) for alanine aminotransaminase (ALT)
or aspartate aminotransaminase (AST), or bilirubin test result
15. Use of prescription or over-the-counter medication, herbal and dietary supplements,
and vitamins and minerals (except the vaccination as required per protocol) within the
21 days before administration of investigational product
16. Female subject of childbearing potential or fertile male subject who are neither using
nor willing to use a highly effective method of contraception
17. Pregnant, lactating, or breastfeeding
18. Donation or loss of more than 500 mL of blood within 3 months, or donated plasma
within 7 days, before admission to the unit and for 5 half-lives or until the end of
the study, whichever is longer
19. Any planned surgical procedures during the study period
20. Participation in any other investigational product study in which receipt of an
investigational product occurred within 5 half-lives or 28 days (whichever is longer)
before dosing of investigational product, or participation in more than 4 clinical
studies involving administration of an investigational product within the last 12
months before Screening
21. Subject who met all eligibility criteria but was not needed (ie, alternate subjects).
Alternate subjects are eligible to participate in subsequent cohorts.
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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 administering the treatment/s
The people assessing the outcomes
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
Recruiting
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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
28/09/2023
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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
1/03/2025
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Nucleus Network Pty Ltd - Herston
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Recruitment postcode(s) [1]
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4006 - Herston
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
CSL Behring
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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
First-In-Human Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And
Pharmacodynamics Of Escalating Single And Multiple Doses Of CSL040 In Healthy Subjects
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05937581
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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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Study Director
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Address
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CSLBehring LLC
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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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Trial Registration Coordinator
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Address
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Country
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Phone
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1-610-878-4000
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05937581
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