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

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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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Double Blind

76 participants in 2 patient groups, including a placebo group

SAR442501
Experimental group
Treatment:
Drug: SAR442501
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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