A First-in-human Single and Repeated Dose Escalation Study of SAR442501 in Healthy Adults Subjects

Phase 1

Completed

• Conditions: Osteochondrodysplasia
• Interventions: Drug: Placebo; Drug: SAR442501

• Registration Number: NCT05846009
• Lead Sponsor: Sanofi

Brief Summary

The purpose of the first-in-human (FIH) study is to obtain safety, tolerability, and pharmacokinetic information on SAR442501 in a healthy adult volunteer population using an integrated single ascending dose (SAD)-multiple ascending dose (MAD) parallel cohort study design.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-18
• Primary Completion: 2022-01-12
• Study Completion: 2022-01-12
• Study First Submitted: 2023-04-26
• Study First Submitted QC: 2023-04-26
• Study First Posted: 2023-05-06
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-23
• Last Update Posted: 2024-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• Male and female participants, between 18 and 45 years of age, inclusive.
• Body weight between 50.0 and 85.0 kg, inclusive, body mass index between 18.0 and 32.0 kg/m2, inclusive.
• Certified as healthy by a comprehensive clinical assessment.
• Having given written informed consent prior to undertaking any study-related procedure.

Exclusion Criteria

• Any history or presence of clinically relevant medical status as per the protocol.
• 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 the potential participation in a clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
SAR442501	SAR442501	-

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events/treatment-emergent adverse events/adverse events of special interest	Baseline up to end of study (EOS) (Day 89)

Secondary Outcome Measures

Name	Time	Method
Assessment of PK parameter: Partial area under the serum concentration time curve (AUC)	Baseline up to EOS (Day 89)
Assessment of PK parameter: Maximum observed concentration (Cmax)	Baseline up to EOS (Day 89)
Immunogenicity: evaluate the presence of anti-SAR442501 antibodies	Baseline up to EOS (Day 89)
Assessment of PK parameter: First time to reach Cmax (tmax)	Baseline up to EOS (Day 89)

Trial Locations

Locations (1)

Investigational site; 🇺🇸 Newark, New Jersey, United States