At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1 Double-blind, Randomized, Placebo-Controlled, Staggered, Single and Multiple Ascending Dose, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of GS-5745 in Subjects With Moderate to Severe Ulcerative Colitis
In Brief
A Phase 1 clinical trial evaluating Andecaliximab and Placebo to match Andecaliximab for Ulcerative Colitis. Completed, enrolled 74 participants across 16 sites in 7 countries.
Detailed 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.
Study Details
Timeline
Interventions
Andecaliximab administered by intravenous (IV) infusion or subcutaneous (SC) injection
Placebo to match andecaliximab administered by IV infusion