NCT05378997

Safety, Tolerability, and Pharmacokinetics of Ascending Topical Doses of TCP-25 Applied to Epidermal Suction Blister Wounds, Non-Healing Leg Ulcers and Patients With Dystrophic Epidermolysis Bullosa.

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study in Healthy Male and Female Volunteers to Investigate the Safety, Tolerability, and Pharmacokinetics of Ascending Topical Doses of TCP-25 Applied to Epidermal Suction Blister Wounds and in Patients With Non-Healing Leg Ulcers and Patients With Dystrophic Epidermolysis Bullosa

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Xinnate AB · Industry
• Sex: All
• Age: 15 Years
• Healthy volunteers: Accepted

Summary

This is a three-part, Phase I, first-in-human study designed to evaluate the safety, tolerability, and potential systemic exposure of multiple topical doses of TCP-25. Part I includes healthy volunteers with acute epidermal wounds formed by the suction blister technique. Part II includes patients with non-healing leg ulcers and Part III patients with dystrophic epidermolysis bullosa (DEB).

Conditions

• Blister
• Wound of Skin
• Epidermolysis Bullosa
• Varicose Ulcer of Lower Limb

Interventions

Type	Name	Description
DRUG	TCP-25 gel 0.86 mg/ml or placebo gel	TCP-25 gel (0.86 mg/mL) applied to two wounds per patient and placebo gel applied to two wounds per patient
DRUG	TCP-25 gel 2.9 mg/ml or placebo gel	TCP-25 gel (2.9 mg/mL) applied to two wounds per patient and placebo gel applied to two wounds per patient
DRUG	TCP-25 gel 8.6 mg/ml or placebo gel	TCP-25 gel (8.6 mg/mL) applied to two wounds per patient and placebo gel applied to two wounds per patient

Timeline

• Start date: 2022-04-07
• Primary completion: 2024-03-16
• Completion: 2024-03-16
• First posted: 2022-05-18
• Last updated: 2024-03-26

Locations

1 site across 1 country: Sweden