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Terminated Phase 1 Interventional

Single Ascending Dose Study of SAR439459 in Adults With Osteogenesis Imperfecta (OI)

ClinicalTrials.gov ID: NCT05231668

Public ClinicalTrials.gov record NCT05231668. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 11:13 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1b, Single Ascending Dose, Randomized, Double-blind Study to Evaluate the Safety, Tolerability, and Activity of SAR439459 in Adults With Osteogenesis Imperfecta

Study identification

NCT ID
NCT05231668
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 1
Lead sponsor
Sanofi
Industry
Enrollment
16 participants

Conditions and interventions

Interventions

  • SAR439459 Drug
  • Placebo Drug

Drug

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 24, 2022
Primary completion
Nov 11, 2024
Completion
Nov 11, 2024
Last update posted
Sep 10, 2025

2022 – 2024

United States locations

U.S. sites
7
U.S. states
7
U.S. cities
7
Facility City State ZIP Site status
UCLA Health_Site Number: 8400006 Los Angeles California 90095
Yale University - Site Number:8400007 New Haven Connecticut 06510
Indiana University School of Medicine_Site Number: 8400002 Indianapolis Indiana 46202
Kennedy Krieger Institute_Site number 8400004 Baltimore Maryland 21205
Cincinnati Children's Hospital Medical Center Site Number : 8400010 Cincinnati Ohio 45229
Vanderbilt University Site Number : 8400011 Nashville Tennessee 37232
Baylor College of Medicine - Site Number:8400003 Houston Texas 77030

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05231668, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 10, 2025 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05231668 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →