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NCT01367444 · ClinicalTrials.gov registry record · Phase 1
Phase I/IIA Study of SAR422459 in Participants With Stargardt's Macular Degeneration
A Phase 1 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT01367444: Clinical Trial Phase 1 study, sponsored by Sanofi.
NCT01367444 is a Phase 1 study that was terminated before completion, run by Sanofi. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01367444, a Phase 1 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
Primary Objective: To assess the safety and tolerability of ascending doses of SAR422459 in participants with Stargardt's Macular Degeneration (SMD). Secondary Objective: To evaluate for possible biological activity of SAR422459.
Primary Outcome
An adverse event (AE) was any unfavorable and unintended physical sign, symptom, or laboratory parameter that developed or worsened in severity during the course of the study, whether or not considered related to the investigational product. The TEAEs were defined as any event that started or increased in severity after the participant received investigational medicinal product (IMP), including abnormal laboratory results, electrocardiogram, etc.
Interventions
- DRUG SAR422459
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2011-06-08 |
| Est. Completion | 2019-08-16 |
| Phase | Phase 1 |
Why NCT01367444 stopped before completion
NCT01367444 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 1 intervention - of which SAR422459 is the first listed.
NCT01367444 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01367444 about?
NCT01367444 is a clinical study titled "Phase I/IIA Study of SAR422459 in Participants With Stargardt's Macular Degeneration". Primary Objective: To assess the safety and tolerability of ascending doses of SAR422459 in participants with Stargardt's Macular Degeneration (SMD). Secondary Objective: To evaluate for possible biological activity of SAR422459.
What is the current status of trial NCT01367444?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2011-06-08. Estimated completion is 2019-08-16.
What interventions are being tested in trial NCT01367444?
The interventions under investigation include: SAR422459 (DRUG).
Who is sponsoring clinical trial NCT01367444?
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 NCT01367444's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 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
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