drugset / Trial / NCT02833389

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

NCT02833389

Phase 1 Completed 72 enrolled Genentech, Inc.
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2016-11-14
Primary completion
2018-11-12
Completion
2018-11-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Efmarodocokin Alfa Protein / enzyme biologic Subcutaneous

Indications