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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 is a Phase 1 study that was terminated before completion, run by Sanofi. The registered enrollment target is 16 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05231668
The ClinicalTrials.gov registry entry for NCT05231668 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05231668 reports 0 study locations.
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.
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