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

NCT05846009 | Completed Phase 1 FDA Drug

• 1 other identifier: TDU16639/TDR16640
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteochondrodysplasia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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)

Study Arms (2)

SAR442501

EXPERIMENTAL

Drug: SAR442501

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SAR442501 DRUG

Subcutaneous injection

SAR442501

Placebo DRUG

Subcutaneous injection

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Investigational site

Newark, New Jersey, 07103, United States

Location

Related Links

• TDU16639/TDR16640 Plain language Results Summary

MeSH Terms

Conditions

Osteochondrodysplasias

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 6, 2023
• Study Start: November 18, 2020
• Primary Completion: January 12, 2022
• Study Completion: January 12, 2022
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)