NCT01984047

Single Dose Escalation Trial to Evaluate the Safety, Tolerability Pharmacokinetics and Pharmacodynamics of GSK3050002

A Phase 1, Randomized, Double-Blind (Sponsor Open), Placebo-Controlled, Single Dose Escalation Trial to Evaluate the Safety, Tolerability Pharmacokinetics and Pharmacodynamics of GSK3050002 (Anti-CCL20 Monoclonal Antibody) in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of GSK3050002 in humans. Subjects will attend the clinical unit for a screening visit and if eligible and consenting, will attend to participate in the study within 30 days. Subjects will be admitted to the clinical unit the evening prior to dosing when each subject will receive a single intravenous dose of GSK3050002 or placebo, then remain in house under supervision until discharged on Day 3. Subjects will then return for 7 outpatient visits scheduled over the following 81 days. Finally, the follow-up visit will be 7-14 days following the last visit.

Conditions

• Colitis, Ulcerative

Interventions

Type	Name	Description
DRUG	GSK3050002	GSK3050002 is a white to off-white lyophilized powder that will be reconstituted with sterile water for intravenous infusion. It is available in the concentrations of 0.1 milligram (mg)/kg, 0.5 mg/kg, 1 mg/kg, 5 mg/kg, 10 mg/kg and 20 mg/kg.
DRUG	Placebo	Placebo contains normal saline (0.9% sodium chloride) for intravenous infusion

Timeline

• Start date: 2014-01-10
• Primary completion: 2015-02-23
• Completion: 2015-02-23
• First posted: 2013-11-14
• Last updated: 2018-07-24

Locations

1 site across 1 country: United Kingdom