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

Sanofi

Status and phase

Completed

Phase 1

Conditions

Osteochondrodysplasia

Treatments

Drug: Placebo

Drug: SAR442501

Study type

Interventional

Funder types

Industry

Identifiers

NCT05846009

TDU16639/TDR16640

Details and patient eligibility

About

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.

Enrollment

76 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.