Trials / Completed
CompletedNCT04077671
CHF6467 SAD and MAD in Patients With Diabetic Foot Ulcer
A Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles of CHF6467 After Single and Repeated Ascending Doses in Subjects With Diabetic Neurophatic Foot Ulcers (DFU).
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 93 (actual)
- Sponsor
- Chiesi Farmaceutici S.p.A. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
To assess the safety and tolerability of single and multiple days' topical dosing with CHF6467 in subjects with diabetic foot ulcer (DFU).
Detailed description
This first in human study is designed to investigate the tolerability, safety, pharmacokinetics and preliminarily pharmacodynamics following topical administration of single and multiple ascending doses of CHF6467 in subjects diagnosed with diabetic foot ulcer (DFU).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CHF6467 active | CHF6467, is mutated form of the human Nerve Growth Factor (NGF). |
Timeline
- Start date
- 2018-10-17
- Primary completion
- 2021-01-07
- Completion
- 2021-01-07
- First posted
- 2019-09-04
- Last updated
- 2022-02-23
Locations
1 site across 1 country: Bulgaria
Source: ClinicalTrials.gov record NCT04077671. Inclusion in this directory is not an endorsement.