A Phase I, First-in-human, Two-part, Randomized, Placebo-controlled, Double-blind, Single and Repeated Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Doses of SAR442501 in Healthy Adult Subjects

Sanofi1 site in 1 country76 target enrollmentNovember 18, 2020

ConditionsOsteochondrodysplasia

InterventionsSAR442501 Placebo

Overview

Phase: Phase 1
Intervention: SAR442501
Conditions: Osteochondrodysplasia
Sponsor: Sanofi
Enrollment: 76
Locations: 1
Primary Endpoint: Number of participants with adverse events/treatment-emergent adverse events/adverse events of special interest
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 18, 2020

End Date

January 12, 2022

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Sanofi

Responsible Party

Sponsor

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.

Arms & Interventions

SAR442501

Intervention: SAR442501

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Number of participants with adverse events/treatment-emergent adverse events/adverse events of special interest

Time Frame: Baseline up to end of study (EOS) (Day 89)

Secondary Outcomes

Assessment of PK parameter: Partial area under the serum concentration time curve (AUC)(Baseline up to EOS (Day 89))
Assessment of PK parameter: Maximum observed concentration (Cmax)(Baseline up to EOS (Day 89))
Immunogenicity: evaluate the presence of anti-SAR442501 antibodies(Baseline up to EOS (Day 89))
Assessment of PK parameter: First time to reach Cmax (tmax)(Baseline up to EOS (Day 89))