A Study to Test if SAR443809 is Tolerated and Safe When Taken as a Single Dose in Healthy Adults
- Conditions
- Paroxysmal Nocturnal Hemoglobinuria
- Interventions
- Drug: Humanized anti-Factor Bb monoclonal antibodyDrug: Placebo
- Registration Number
- NCT06326814
- Lead Sponsor
- Sanofi
- Brief Summary
Primary objective
* The tolerability and safety of SAR443809 Secondary
* The PK parameters of SAR443809
* The PD activity of SAR443809
* The immunogenicity of SAR443809
- Detailed Description
Screening: up to 56 days (Day -56 to Day -2). Treatment: 1 day (treatment on Day 1, study observation period from Day -1 to Day 3). Follow-up and end of study: 105 days after IMP administration (follow up visits from Day 5 to Day 78; End of study visit on Day 106). Total study duration for each participant: approximately 23 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
Having given written informed consent prior to undertaking any study-related procedure
Participants are excluded from the study if any of the following criteria apply:
Any participant who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description SAR443809 and placebo dose 4 Arm Placebo 6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 4 SAR443809 and placebo dose 3 Arm Humanized anti-Factor Bb monoclonal antibody 6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 3 SAR443809 and placebo dose 3 Arm Placebo 6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 3 SAR443809 and placebo dose 4 Arm Humanized anti-Factor Bb monoclonal antibody 6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 4 SAR443809 and placebo dose 1 Arm Placebo 6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 1 SAR443809 and placebo dose 1 Arm Humanized anti-Factor Bb monoclonal antibody 6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 1 SAR443809 and placebo dose 2 Arm Humanized anti-Factor Bb monoclonal antibody 6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 2 SAR443809 and placebo dose 2 Arm Placebo 6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 2 SAR443809 and placebo dose 6 Arm Humanized anti-Factor Bb monoclonal antibody Optional: 6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 6 SAR443809 and placebo dose 5 Arm Humanized anti-Factor Bb monoclonal antibody 6 participants receiving SAR443809 and 2 receiving placebo, subcutaneous administration dose 5 SAR443809 and placebo dose 7 Arm Humanized anti-Factor Bb monoclonal antibody Optional: 6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 7 SAR443809 and placebo dose 5 Arm Placebo 6 participants receiving SAR443809 and 2 receiving placebo, subcutaneous administration dose 5 SAR443809 and placebo dose 7 Arm Placebo Optional: 6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 7 SAR443809 and placebo dose 6 Arm Placebo Optional: 6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 6
- Primary Outcome Measures
Name Time Method Incidence of potentially Clinical laboratory abnormalities Baseline up to 23 weeks Number of participants with adverse events (AEs)/treatment-emergent adverse events (TEAEs) Baseline up to 23 weeks
- Secondary Outcome Measures
Name Time Method PK parameters of SAR443809 for IV and SC administrations: Maximum plasma concentration observed (Cmax Baseline up to 23 weeks PK parameters of SAR443809 for IV and SC administrations: Time corresponding to the last concentration above the limit of quantification (Clast tlast) Baseline up to 23 weeks PK parameters of SAR443809 for IV and SC administrations: total body clearance of a drug from the plasma calculated by dividing dose by AUC (CL) Baseline up to 23 weeks PK parameters of SAR443809 for IV and SC administrations: volume of distribution at steady-state (Vss) Baseline up to 23 weeks PK parameters of SAR443809 for SC administrations: apparent volume of distribution at steady-state (Vss/F) Baseline up to 23 weeks Complement alternative pathway activity (Wieslab AP and alternative pathway hemolytic activity [AH50]) Baseline up to 23 weeks Ex vivo activity of the alternative pathway of complement in serum using the WIESLAB® Complement System Alternative Pathway kit and a hemolytic assay (AH50)
Complement classical pathway activity (Wieslab CP) Baseline up to 23 weeks Ex vivo activity of the alternative pathway of complement in serum using the WIESLAB® Complement System Classical Pathway kit
Incidence of treatment -emergent Anti-SAR443809 antibodies Baseline up to 23 weeks PK parameters of SAR443809 for IV and SC administrations: First time to reach Cmax (tmax Baseline up to 23 weeks PK parameters of SAR443809 for IV and SC administrations: Area under the plasma concentration versus time curve extrapolated to infinity (AUC0-∞) Baseline up to 23 weeks PK parameters of SAR443809 for IV and SC administrations: Terminal half-life associated with the terminal slope (λz) (t1/2z) Baseline up to 23 weeks PK parameters of SAR443809 for SC administrations: apparent total body clearance of the SC formulation (CL/F) Baseline up to 23 weeks PK parameters of SAR443809 for SC administrations: absolute bioavailability (F) Baseline up to 23 weeks PK parameters of SAR443809 for IV and SC administrations: Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to tlast (AUClast) Baseline up to 23 weeks
Trial Locations
- Locations (2)
Parexel International Site Number : 8400002
🇺🇸Glendale, California, United States
Parexel International Site Number : 8400003
🇺🇸Baltimore, Maryland, United States
Parexel International Site Number : 8400002🇺🇸Glendale, California, United States