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

Metabolic Disorder
Type 1 Diabetes Mellitus
Diabetic Complication
Type 2 Diabetes Mellitus

For Medical Professional
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Basic Details

Sponsor Genentech, Inc.

Phase Phase 1

Study Identifier NCT02833389, GX29915, 2015-003283-36

Condition Neuropathic Diabetic Foot Ulcers

Official Title 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

Study 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.

Eligibility Criteria

Gender

All

Age

≥ 18 Years

Healthy Volunteers

Inclusion Criteria

Have a diagnosis of Type 1 or Type 2 diabetes and confirmed peripheral neuropathy
Have adequate circulation to the foot
Have an ulcer area at screening up to 6 cm^2
Up to date on all age-appropriate cancer screenings per local standards

Exclusion Criteria

Have current evidence of osteomyelitis, cellulitis, or evidence of systemic infection
Have gangrene present on any part of the affected foot
Known peripheral arterial disease requiring revascularization
Have a glycated hemoglobin A1C level of greater than (>) 15% assessed at screening
Are receiving oral or parenteral corticosteroids, immunosuppressive, or cytotoxic agents
Have active malignancy or any history of a malignancy
Use of oral antibiotics at the time of randomization for any reason in participants to be enrolled in Cohorts A, B, E, and any additional uninfected patient cohorts

This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

Results Disclaimer

What is Clinical Research?

In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.

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

Basic Details

Study Summary

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com

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

For the latest version of this information please go to www.forpatients.roche.com