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

Completed · Phase 1 · Has a placebo group

Conditions studied: Osteochondrodysplasia

In brief

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.

Key facts

Study ID

NCT05846009

Run by

Sanofi

People needed

76

Starts

2020-11-18

Expected to finish

2022-01-12

Last updated by the study team

2024-08-27

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Investigational site — Newark, New Jersey, United States

Full record on ClinicalTrials.gov

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