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Completed

NCT Number: NCT05846009

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

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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Key information

Conditions

Osteochondrodysplasia Bone Diseases Bone Diseases, Developmental Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Musculoskeletal Diseases Osteochondrodysplasias

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational site

Newark, New Jersey, 07103, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SAR442501

Drug

Subcutaneous injection

Placebo

Drug

Subcutaneous injection

Primary outcomes

  1. 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

  1. Assessment of PK parameter: Maximum observed concentration (Cmax)

    Time frame: Baseline up to EOS (Day 89)

  2. Assessment of PK parameter: First time to reach Cmax (tmax)

    Time frame: Baseline up to EOS (Day 89)

  3. Assessment of PK parameter: Partial area under the serum concentration time curve (AUC)

    Time frame: Baseline up to EOS (Day 89)

  4. Immunogenicity: evaluate the presence of anti-SAR442501 antibodies

    Time frame: Baseline up to EOS (Day 89)

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 6, 2023
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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