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A First-In-Human Randomized Controlled Phase 1 Study Assessing the Safety and Tolerability of Topical TCP-25 Gel in Epidermal Suction Blister Wounds

Wallblom, Karl LU orcid ; Lundgren, Sigrid LU ; Petruk, Ganna LU orcid ; Puthia, Manoj LU ; Fisher, Jane LU ; Hugerth, Matilda ; Saleh, Karim LU and Schmidtchen, Artur LU (2026) In Clinical and Translational Science 19(2).
Abstract

Inflammation and infection remain unmet challenges in wounds of various etiologies, delaying healing, impacting quality of life, and increasing healthcare costs. The thrombin-derived C-terminal peptide TCP-25 has demonstrated dual anti-inflammatory and antibacterial activities in animal wound infection models, thereby promoting healing, highlighting its therapeutic potential as a wound treatment. This first-in-human, double-blind, randomized, within-person and placebo-controlled clinical trial (NCT05378997) evaluated the safety, tolerability, and pharmacokinetics of topical TCP-25 in healthy volunteers. Twenty-four participants each received four suction blister wounds (two per thigh), with two wounds treated with TCP-25 (either 0.86,... (More)

Inflammation and infection remain unmet challenges in wounds of various etiologies, delaying healing, impacting quality of life, and increasing healthcare costs. The thrombin-derived C-terminal peptide TCP-25 has demonstrated dual anti-inflammatory and antibacterial activities in animal wound infection models, thereby promoting healing, highlighting its therapeutic potential as a wound treatment. This first-in-human, double-blind, randomized, within-person and placebo-controlled clinical trial (NCT05378997) evaluated the safety, tolerability, and pharmacokinetics of topical TCP-25 in healthy volunteers. Twenty-four participants each received four suction blister wounds (two per thigh), with two wounds treated with TCP-25 (either 0.86, 2.9, or 8.6 mg/mL) and two with placebo gel, 5 times over 8 days. For the primary safety endpoint, no serious or significant adverse events or withdrawals due to adverse events were reported. Twenty-one participants (88%) reported at least 1 adverse event; all were mild or moderate and judged to be unlikely related to TCP-25 treatment. No abnormal local reactions occurred and no clinically relevant changes in electrocardiogram, vital signs, laboratory parameters, or physical examination findings were observed between baseline and end of treatment. For the secondary endpoint, TCP-25 was undetectable (< 90 nmol/L) in all plasma samples at all timepoints. Thus, topical TCP-25 gel was safe and well tolerated by healthy volunteers with epidermal wounds, with no evidence of measurable systemic exposure. Exploratory analyses indicated reduced wound exudation with TCP-25 treatment, particularly at 2.9 and 8.6 mg/mL. Taken together, these findings support further clinical evaluation of TCP-25 in relevant patient populations.

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author
; ; ; ; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
epidermolysis bullosa, inflammation, therapeutic peptide, wound exudation
in
Clinical and Translational Science
volume
19
issue
2
article number
e70497
publisher
Wiley-Blackwell
external identifiers
  • pmid:41645556
  • scopus:105029551119
ISSN
1752-8054
DOI
10.1111/cts.70497
language
English
LU publication?
yes
additional info
Publisher Copyright: © 2026 The Author(s). Clinical and Translational Science published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.
id
1e6435f5-f023-4676-8770-3ef6697373d6
date added to LUP
2026-02-23 08:36:13
date last changed
2026-02-23 10:26:05
@article{1e6435f5-f023-4676-8770-3ef6697373d6,
  abstract     = {{<p>Inflammation and infection remain unmet challenges in wounds of various etiologies, delaying healing, impacting quality of life, and increasing healthcare costs. The thrombin-derived C-terminal peptide TCP-25 has demonstrated dual anti-inflammatory and antibacterial activities in animal wound infection models, thereby promoting healing, highlighting its therapeutic potential as a wound treatment. This first-in-human, double-blind, randomized, within-person and placebo-controlled clinical trial (NCT05378997) evaluated the safety, tolerability, and pharmacokinetics of topical TCP-25 in healthy volunteers. Twenty-four participants each received four suction blister wounds (two per thigh), with two wounds treated with TCP-25 (either 0.86, 2.9, or 8.6 mg/mL) and two with placebo gel, 5 times over 8 days. For the primary safety endpoint, no serious or significant adverse events or withdrawals due to adverse events were reported. Twenty-one participants (88%) reported at least 1 adverse event; all were mild or moderate and judged to be unlikely related to TCP-25 treatment. No abnormal local reactions occurred and no clinically relevant changes in electrocardiogram, vital signs, laboratory parameters, or physical examination findings were observed between baseline and end of treatment. For the secondary endpoint, TCP-25 was undetectable (&lt; 90 nmol/L) in all plasma samples at all timepoints. Thus, topical TCP-25 gel was safe and well tolerated by healthy volunteers with epidermal wounds, with no evidence of measurable systemic exposure. Exploratory analyses indicated reduced wound exudation with TCP-25 treatment, particularly at 2.9 and 8.6 mg/mL. Taken together, these findings support further clinical evaluation of TCP-25 in relevant patient populations.</p>}},
  author       = {{Wallblom, Karl and Lundgren, Sigrid and Petruk, Ganna and Puthia, Manoj and Fisher, Jane and Hugerth, Matilda and Saleh, Karim and Schmidtchen, Artur}},
  issn         = {{1752-8054}},
  keywords     = {{epidermolysis bullosa; inflammation; therapeutic peptide; wound exudation}},
  language     = {{eng}},
  number       = {{2}},
  publisher    = {{Wiley-Blackwell}},
  series       = {{Clinical and Translational Science}},
  title        = {{A First-In-Human Randomized Controlled Phase 1 Study Assessing the Safety and Tolerability of Topical TCP-25 Gel in Epidermal Suction Blister Wounds}},
  url          = {{http://dx.doi.org/10.1111/cts.70497}},
  doi          = {{10.1111/cts.70497}},
  volume       = {{19}},
  year         = {{2026}},
}