Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GS-5745 (Andecaliximab) in Adults With Moderate to Severe Active Ulcerative Colitis
Completed · Phase 1 · Has a placebo group
Conditions studied: Ulcerative Colitis
In brief
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.
Key facts
- Study ID
- NCT01831427
- Run by
- Gilead Sciences
- People needed
- 74
- Starts
- 2013-03-28
- Expected to finish
- 2015-02-06
- Last updated by the study team
- 2021-02-01
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Delta Research Partners LLC — Monroe, Louisiana, United States
- Walter Reed National Military Medical Center — Bethesda, Maryland, United States
- Clinical Research Institute of Michigan — Chesterfield Township, MI 48047, Michigan, United States
- Ehrhardt Clinical Research, LLC — Belton, Missouri, United States
- Duke University Medical Center — Durham, North Carolina, United States
- Community Research — Cincinnati, Ohio, United States
- UZ Leuven — Leuven, Belgium
- GIRI — Vancouver, British Columbia, Canada
- LHSC University Campus — London, Ontario, Canada
- Clinical Pharma Center of Kenezy Gyula Korhaz Rendelointezet — Debrecen, Hajdú-Bihar, Hungary
- Semmelweis Egyetem Altalanos Orvostudomanyi Kar — Budapest, Pest County, Hungary
- Drug Research Centre — Balatonfüred, Hungary
- Republican Clinical Hospital — Chisinau, Moldova
- Academic Medical Center — Amsterdam, Netherlands
- Academisch Ziekenhuis Maastricht — Maastricht, Netherlands
- Institute of Pulmonology "Marius Nasta" — Bucharest, Romania
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.