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

CompletedPhase 1

Sponsor: Sanofi

Conditions: Osteochondrodysplasia

Interventions: SAR442501, Placebo

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 45 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility 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.

Locations (1)

Newark, New Jersey, United States