Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05231668 · ClinicalTrials.gov registry record · Phase 1
Single Ascending Dose Study of SAR439459 in Adults With Osteogenesis Imperfecta (OI)
A Phase 1 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT05231668: Clinical Trial Phase 1 study, sponsored by Sanofi.
NCT05231668 is a Phase 1 study that was terminated before completion, run by Sanofi. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05231668, a Phase 1 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
SAR439459 is a human anti-Transforming growth factor β (TGFβ) monoclonal antibody. This phase 1 clinical study investigates the safety, tolerability, and activity of a single dose of SAR439459 in adult participants with OI. Participants will receive a single IV dose of SAR439459 with safety, pharmacokinetic (PK), and pharmacodynamic (PD) assessments over 24 weeks. There will be up to 3 dose cohorts. In addition to safety, tolerability, and PK assessments, bone mineral density (BMD) will be evaluated by dual-energy Xray absorptimetry (DXA) scan and a series of blood biomarkers will be monitored to document pharmacodynamic effects of the single dose of SAR439459.
Interventions
- DRUG Placebo
- DRUG SAR439459
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2022-08-25 |
| Est. Completion | 2024-11-12 |
| Phase | Phase 1 |
Why NCT05231668 stopped before completion
NCT05231668 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05231668 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05231668 about?
NCT05231668 is a clinical study titled "Single Ascending Dose Study of SAR439459 in Adults With Osteogenesis Imperfecta (OI)". SAR439459 is a human anti-Transforming growth factor β (TGFβ) monoclonal antibody. This phase 1 clinical study investigates the safety, tolerability, and activity of a single dose of SAR439459 in adult participants with OI. Participants will receive a single IV dose of SAR439459 with safety, pharma...
What is the current status of trial NCT05231668?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2022-08-25. Estimated completion is 2024-11-12.
What interventions are being tested in trial NCT05231668?
The interventions under investigation include: Placebo (DRUG), SAR439459 (DRUG).
Who is sponsoring clinical trial NCT05231668?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05231668's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02422641 · 16 participants · Phase 2
Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis
- NCT02851758 · 16 participants · NA
Transplantation of Autologously Derived Mitochondria Following Ischemia
- NCT03291028 · 16 participants
Analysis of Primary and Metastatic Tumors in Patients With Renal Cell Carcinoma and Urothelial Carcinoma
- NCT03425526 · 16 participants · Phase 1
Donor T Cell Therapy in Treating Immunocompromised Patients With Adenovirus-Related Disease
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI