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NCT01831427 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GS-5745 (Andecaliximab) in Adults With Moderate to Severe Active Ulcerative Colitis
A Phase 1 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 74
- Enrollment target
NCT01831427: Completed Phase 1 study, sponsored by Gilead Sciences.
NCT01831427 is a Phase 1 study that has completed, run by Gilead Sciences. The registered enrollment target is 74 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01831427, a Phase 1 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 74 participants
- Enrollment target
Study Summary
The primary objectives of this study are as follows: * To assess the safety and tolerability of escalating single and multiple doses of GS-5745 (andecaliximab) in participants with moderate to severe ulcerative colitis (UC) as assessed by adverse events (AEs) and laboratory abnormalities * To assess the pharmacokinetics (PK) of GS-5745 (andecaliximab) in participants with moderate to severe UC.
Primary Outcome
TEAEs are any AEs with an onset date of on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or any AEs leading to premature discontinuation of study drug.
Interventions
- DRUG Andecaliximab
- DRUG Placebo to match Andecaliximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2013-03-28 |
| Est. Completion | 2015-02-06 |
| Phase | Phase 1 |
What the finished NCT01831427 record still lists
NCT01831427 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% higher).
The record links to 0 conditions, and to 2 interventions - of which Andecaliximab is the first listed.
NCT01831427 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01831427 about?
NCT01831427 is a clinical study titled "Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GS-5745 (Andecaliximab) in Adults With Moderate to Severe Active Ulcerative Colitis". The primary objectives of this study are as follows: * To assess the safety and tolerability of escalating single and multiple doses of GS-5745 (andecaliximab) in participants with moderate to severe ulcerative colitis (UC) as assessed by adverse events (AEs) and laboratory abnormalities * To asses...
What is the current status of trial NCT01831427?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 2013-03-28. Estimated completion is 2015-02-06.
What interventions are being tested in trial NCT01831427?
The interventions under investigation include: Andecaliximab (DRUG), Placebo to match Andecaliximab (DRUG).
Who is sponsoring clinical trial NCT01831427?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01831427's enrollment target sits among peer trials
74 725th of 2000 higher than 1,269 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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