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 Number of participants with adverse events (AEs)/treatment-emergent adverse events (TEAEs) Baseline up to 23 weeks Incidence of potentially Clinical laboratory abnormalities Baseline up to 23 weeks
- Secondary Outcome Measures
Name Time Method 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 Incidence of treatment -emergent Anti-SAR443809 antibodies Baseline up to 23 weeks 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 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 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
Trial Locations
- Locations (2)
Parexel International Site Number : 8400002
🇺🇸Glendale, California, United States
Parexel International Site Number : 8400003
🇺🇸Baltimore, Maryland, United States