Clinical trial NCT06326814: A Study to Test if SAR443809 is Tolerated and Safe When Taken as a Single Dose in Healthy Adults
Official title: A First-in-human, Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Single Doses of SAR443809 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Paroxysmal Nocturnal Hemoglobinuria
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2024-03-22
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria: Having given written informed consent prior to undertaking any study-related procedure Exclusion Criteria: 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.

Primary outcomes:
measure: Number of participants with adverse events (AEs)/treatment-emergent adverse events (TEAEs)
timeFrame: Baseline up to 23 weeks
measure: Incidence of potentially Clinical laboratory abnormalities
timeFrame: Baseline up to 23 weeks
Secondary outcomes:
measure: PK parameters of SAR443809 for IV and SC administrations: Maximum plasma concentration observed (Cmax
timeFrame: Baseline up to 23 weeks
measure: PK parameters of SAR443809 for IV and SC administrations: First time to reach Cmax (tmax
timeFrame: Baseline up to 23 weeks
measure: 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)
timeFrame: Baseline up to 23 weeks
measure: PK parameters of SAR443809 for IV and SC administrations: Area under the plasma concentration versus time curve extrapolated to infinity (AUC0-∞)
timeFrame: Baseline up to 23 weeks
measure: PK parameters of SAR443809 for IV and SC administrations: Terminal half-life associated with the terminal slope (λz) (t1/2z)
timeFrame: Baseline up to 23 weeks
measure: PK parameters of SAR443809 for IV and SC administrations: Time corresponding to the last concentration above the limit of quantification (Clast tlast)
timeFrame: Baseline up to 23 weeks
measure: 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)
timeFrame: Baseline up to 23 weeks
measure: PK parameters of SAR443809 for SC administrations: apparent total body clearance of the SC formulation (CL/F)
timeFrame: Baseline up to 23 weeks
measure: PK parameters of SAR443809 for IV and SC administrations: volume of distribution at steady-state (Vss)
timeFrame: Baseline up to 23 weeks
measure: PK parameters of SAR443809 for SC administrations: apparent volume of distribution at steady-state (Vss/F)
timeFrame: Baseline up to 23 weeks
measure: PK parameters of SAR443809 for SC administrations: absolute bioavailability (F)
timeFrame: Baseline up to 23 weeks
measure: Complement alternative pathway activity (Wieslab AP and alternative pathway hemolytic activity [AH50])
timeFrame: Baseline up to 23 weeks
measure: Complement classical pathway activity (Wieslab CP)
timeFrame: Baseline up to 23 weeks
measure: Incidence of treatment -emergent Anti-SAR443809 antibodies
timeFrame: Baseline up to 23 weeks
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Parexel International Site Number : 8400002
state: California
city: Baltimore
country: United States
facility: Parexel International Site Number : 8400003
state: Maryland
Study officials:
References: