NCT02749630

A Safety Study of Intravenously Administered UTTR1147A in Healthy Volunteers (HVs), Participants With Ulcerative Colitis (UC), and Participants With Crohn's Disease (CD)

An Observer-Blinded, Placebo-Controlled, Multiple-Ascending, Dose-Escalation Study to Explore the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Repeat Intravenous Administrations of UTTR1147A in Healthy Volunteers and Patients With Ulcerative Colitis and Crohn's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, observer-blinded, placebo-controlled study to evaluate safety, tolerability, immunogenicity, and pharmacokinetics of repeat dosing of intravenous (IV) UTTR1147A. The study will consist of a repeat dose escalation in HVs, in participants with UC, and in participants with CD across multiple sites.

Conditions

• Ulcerative Colitis
• Crohn's Disease

Interventions

Type	Name	Description
DRUG	Placebo	Matching placebo to UTTR1147A administered intravenously
DRUG	UTTR1147A	Escalating doses of intravenously administered UTTR1147A

Timeline

• Start date: 2016-04-11
• Primary completion: 2020-02-19
• Completion: 2020-02-19
• First posted: 2016-04-25
• Last updated: 2020-10-30

Locations

2 sites across 2 countries: Germany, United Kingdom

Regulatory

• FDA-regulated drug study