A Study to Test if SAR443809 is Tolerated and Safe When Taken as a Single Dose in Healthy Adults
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
2 other identifiers
interventional
54
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2021
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 5, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 5, 2023
CompletedFirst Submitted
Initial submission to the registry
March 5, 2024
CompletedFirst Posted
Study publicly available on registry
March 22, 2024
CompletedMarch 22, 2024
March 1, 2024
1.6 years
March 5, 2024
March 17, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (14)
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: 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 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: 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
- +9 more secondary outcomes
Study Arms (7)
SAR443809 and placebo dose 1 Arm
EXPERIMENTAL6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 1
SAR443809 and placebo dose 2 Arm
EXPERIMENTAL6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 2
SAR443809 and placebo dose 3 Arm
EXPERIMENTAL6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 3
SAR443809 and placebo dose 4 Arm
EXPERIMENTAL6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 4
SAR443809 and placebo dose 5 Arm
EXPERIMENTAL6 participants receiving SAR443809 and 2 receiving placebo, subcutaneous administration dose 5
SAR443809 and placebo dose 6 Arm
EXPERIMENTALOptional: 6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 6
SAR443809 and placebo dose 7 Arm
EXPERIMENTALOptional: 6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 7
Interventions
Pharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration
Pharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration
Eligibility Criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (2)
Parexel International Site Number : 8400002
Glendale, California, 91206, United States
Parexel International Site Number : 8400003
Baltimore, Maryland, 21255, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2024
First Posted
March 22, 2024
Study Start
October 11, 2021
Primary Completion
May 5, 2023
Study Completion
May 5, 2023
Last Updated
March 22, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org