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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-18

Study Completion Date

2022-01-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteochondrodysplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SAR442501

Group Type EXPERIMENTAL

SAR442501

Intervention Type DRUG

Subcutaneous injection

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subcutaneous injection

Interventions

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SAR442501

Subcutaneous injection

Intervention Type DRUG

Placebo

Subcutaneous injection

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes