NCT02833389

The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UTTR1147A in Participants With Neuropathic Non-Healing Diabetic Foot Ulcers

A Phase Ib, Blinded, Randomized, Multicenter, Multiple-Ascending-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UTTR1147A Administered by Subcutaneous Injection in Patients With Non-Healing Neuropathic Diabetic Foot Ulcers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of repeat dosing of UTTR1147A in participants with neuropathic diabetic foot ulcers that do not respond adequately to standard wound care. Participants across multiple sites will be assigned to one of five cohorts (Cohort A, B, C, D, and E) based on the eligibility criteria and randomized to receive subcutaneous (SC) injections of either UTTR1147A or placebo over 12 weeks in addition to standard wound care.

Conditions

• Neuropathic Diabetic Foot Ulcers

Interventions

Type	Name	Description
DRUG	Placebo	UTTR1147A matching placebo will be administered SC.
DRUG	UTTR1147A	UTTR1147A will be administered SC.

Timeline

• Start date: 2016-11-14
• Primary completion: 2018-11-12
• Completion: 2018-11-12
• First posted: 2016-07-14
• Last updated: 2018-11-21

Locations

32 sites across 6 countries: United States, Denmark, Hungary, Italy, Spain, United Kingdom