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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 is a Phase 1 study that has completed, run by Gilead Sciences. The registered enrollment target is 74 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01831427
The ClinicalTrials.gov registry entry for NCT01831427 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Andecaliximab is the first listed.
NCT01831427 reports 0 study locations.
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.
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