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

• Status: Completed
• Trial end date: 2021-07-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sanofi

Criteria

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.