MedTrace Logo

Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GS-5745 (Andecaliximab) in Adults With Moderate to Severe Active Ulcerative Colitis

NCT01831427 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2021-02-01

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Andecaliximab

Andecaliximab administered by intravenous (IV) infusion or subcutaneous (SC) injection

DRUG

Placebo to match Andecaliximab

Placebo to match andecaliximab administered by IV infusion

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-28
Primary Completion
2015-01-05
Completion
2015-02-06
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Hungary
  • Moldova
  • Netherlands
  • Romania

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01831427 on ClinicalTrials.gov