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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

Lundgren, Sigrid LU ; Wallblom, Karl LU orcid ; Fisher, Jane LU ; Erdmann, Susanne ; Schmidtchen, Artur LU and Saleh, Karim LU (2023) In BMJ Open 13(2).
Abstract

Introduction TCP-25 gel is intended for use in treatment of wound infection and inflammation. Current local therapies for wounds have limited efficacy to prevent infections and there are no wound treatments available today that target the excessive inflammation that often hampers wound healing in both acute and chronic wounds. There is therefore a high medical need for new therapeutic alternatives. Methods and analysis A randomised, double-blinded, first-in-human study was designed to evaluate the safety, tolerability and potential systemic exposure of three increasing doses of the TCP-25 gel applied topically on suction blister wounds in healthy adults. The dose-escalation will be divided into three sequential dose groups with eight... (More)

Introduction TCP-25 gel is intended for use in treatment of wound infection and inflammation. Current local therapies for wounds have limited efficacy to prevent infections and there are no wound treatments available today that target the excessive inflammation that often hampers wound healing in both acute and chronic wounds. There is therefore a high medical need for new therapeutic alternatives. Methods and analysis A randomised, double-blinded, first-in-human study was designed to evaluate the safety, tolerability and potential systemic exposure of three increasing doses of the TCP-25 gel applied topically on suction blister wounds in healthy adults. The dose-escalation will be divided into three sequential dose groups with eight subjects in each group (24 patients in total). Within each dose group, the subjects will receive four wounds, with two wounds on each thigh. Each subject will receive TCP-25 on one wound per thigh and placebo on one wound per thigh in a randomised double-blinded manner, with a reverse reciprocal position on each respective thigh, to a total of five doses over 8 days. An internal safety review committee will monitor emerging safety and plasma concentration data over the course of the study and must give a favourable recommendation prior to initiating the next dose group, which will receive placebo gel or a higher concentration of TCP-25 in exactly the same manner described above. Ethics and dissemination The study will be performed in accordance with ethical principles consistent with the Declaration of Helsinki, ICH/GCPE6 (R2), European Union Clinical Trials Directive and applicable local regulatory requirements. This study is approved by the Swedish Medical Products Agency and the Swedish ethics committee under the registration number 2022-00527-01. The results of this study will be disseminated via publication to a peer-reviewed journal at the discretion of the Sponsor. Trial registration number NCT05378997.

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author
; ; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Clinical trials, DERMATOLOGY, WOUND MANAGEMENT
in
BMJ Open
volume
13
issue
2
article number
e064866
publisher
BMJ Publishing Group
external identifiers
  • scopus:85148550723
  • pmid:36813496
ISSN
2044-6055
DOI
10.1136/bmjopen-2022-064866
project
Translational wound healing studies with focus on microbes, inflammation, and methods for non-invasive wound evaluation
language
English
LU publication?
yes
id
e87ac5fe-b713-4a24-95fa-21015bbf0709
date added to LUP
2023-03-15 16:36:19
date last changed
2024-04-17 03:17:43
@article{e87ac5fe-b713-4a24-95fa-21015bbf0709,
  abstract     = {{<p>Introduction TCP-25 gel is intended for use in treatment of wound infection and inflammation. Current local therapies for wounds have limited efficacy to prevent infections and there are no wound treatments available today that target the excessive inflammation that often hampers wound healing in both acute and chronic wounds. There is therefore a high medical need for new therapeutic alternatives. Methods and analysis A randomised, double-blinded, first-in-human study was designed to evaluate the safety, tolerability and potential systemic exposure of three increasing doses of the TCP-25 gel applied topically on suction blister wounds in healthy adults. The dose-escalation will be divided into three sequential dose groups with eight subjects in each group (24 patients in total). Within each dose group, the subjects will receive four wounds, with two wounds on each thigh. Each subject will receive TCP-25 on one wound per thigh and placebo on one wound per thigh in a randomised double-blinded manner, with a reverse reciprocal position on each respective thigh, to a total of five doses over 8 days. An internal safety review committee will monitor emerging safety and plasma concentration data over the course of the study and must give a favourable recommendation prior to initiating the next dose group, which will receive placebo gel or a higher concentration of TCP-25 in exactly the same manner described above. Ethics and dissemination The study will be performed in accordance with ethical principles consistent with the Declaration of Helsinki, ICH/GCPE6 (R2), European Union Clinical Trials Directive and applicable local regulatory requirements. This study is approved by the Swedish Medical Products Agency and the Swedish ethics committee under the registration number 2022-00527-01. The results of this study will be disseminated via publication to a peer-reviewed journal at the discretion of the Sponsor. Trial registration number NCT05378997.</p>}},
  author       = {{Lundgren, Sigrid and Wallblom, Karl and Fisher, Jane and Erdmann, Susanne and Schmidtchen, Artur and Saleh, Karim}},
  issn         = {{2044-6055}},
  keywords     = {{Clinical trials; DERMATOLOGY; WOUND MANAGEMENT}},
  language     = {{eng}},
  month        = {{02}},
  number       = {{2}},
  publisher    = {{BMJ Publishing Group}},
  series       = {{BMJ Open}},
  title        = {{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}},
  url          = {{http://dx.doi.org/10.1136/bmjopen-2022-064866}},
  doi          = {{10.1136/bmjopen-2022-064866}},
  volume       = {{13}},
  year         = {{2023}},
}