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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05846009

Enrollment

Registered

2023-05-06

Start date

2020-11-18

Completion date

2022-01-12

Last updated

2024-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteochondrodysplasia

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.

Interventions

DRUGSAR442501

Subcutaneous injection

DRUGPlacebo

Subcutaneous injection

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	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

Measure	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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026