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

Study Overview
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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.

Official Title
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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

Conditions
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Osteochondrodysplasia

Intervention / Treatment
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* Drug: SAR442501
* Drug: Placebo


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAR442501<br> | Drug: SAR442501<br>* Subcutaneous injection<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Subcutaneous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events/treatment-emergent adverse events/adverse events of special interest |  | Baseline up to end of study (EOS) (Day 89) | 

Secondary Outcome Measures

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