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.

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).

Timeline

Start

2022-04-07

Primary completion

2024-03-16

Completion

2024-03-16

Publications

• Wallblom K, Holmgren K, Lundgren S, Belfrage E, Hoppe T, Hugerth M, Lindqvist AK, Sonkoly E, Schmidtchen A. Results of a non-randomized, open-label phase I study evaluating the novel immunomodulatory peptide TCP-25 for treatment of dystrophic epidermolysis bullosa. Orphanet J Rare Dis. 2025 Dec 2;21(1):4. doi: 10.1186/s13023-025-04156-7.
• Wallblom K, Forsberg F, Lundgren S, Fisher J, Cardoso J, Petruk G, Stromdahl AC, Saleh K, Puthia M, Schmidtchen A. Bactogram: Spatial Analysis of Bacterial Colonisation in Epidermal Wounds. Exp Dermatol. 2024 Dec;33(12):e70018. doi: 10.1111/exd.70018.
• Lundgren S, Wallblom K, Fisher J, Erdmann S, Schmidtchen A, Saleh K. Study protocol for a phase 1, randomised, double-blind, placebo-controlled study to investigate the safety, tolerability and pharmacokinetics of ascending topical doses of TCP-25 applied to epidermal suction blister wounds in healthy male and female volunteers. BMJ Open. 2023 Feb 22;13(2):e064866. doi: 10.1136/bmjopen-2022-064866.

Drugs

Indications