Safety, Tolerability, and Pharmacokinetics of Ascending Topical Doses of TCP-25 Applied to Epider… (NCT05378997) | Clinical Trial Compass
CompletedPhase 1
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.
Sweden35 participantsStarted 2022-04-07
Plain-language 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).
Who can participate
Age range
15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Willing and able to give written informed consent for participation in the study.
. Healthy male or female subject 18-60 years (inclusive) of age at the time of signing the informed consent.
. Body Mass Index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2.
. Healthy and intact skin where the blister suction wounds will be induced.
. Women of childbearing potential (WOCBP) must have a documented negative serum pregnancy test done at the screening visit, within 4 weeks prior to suction blister formation and the start of study treatment.
. Clinically relevant medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse Events
Timeframe: 15 days in Part I (modified endpoints & timeframes in Part II & III)
2
Incidence of abnormal local reactions (Local tolerability)
Timeframe: Day 1 in Part I (modified endpoints & timeframes in Part II & III)
3
Incidence of abnormal local reactions (Local tolerability)
Timeframe: Day 2 in Part I (modified endpoints & timeframes in Part II & III)
4
Incidence of abnormal local reactions (Local tolerability)
Timeframe: Day 3 in Part I (modified endpoints & timeframes in Part II & III)
5
Incidence of abnormal local reactions (Local tolerability)
Timeframe: Day 5 in Part I (modified endpoints & timeframes in Part II & III)
6
Incidence of abnormal local reactions (Local tolerability)
Timeframe: Day 8 in Part I (modified endpoints & timeframes in Part II & III)
7
Incidence of abnormal local reactions (Local tolerability)
. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
. Disease that may interfere with wound healing, e.g., diabetes type I/II, arterial-, renal-, liver, or cardiac insufficiency, chronic obstructive lung disease, cancer, autoimmune disease, edema at the study site, severe obesity, or previous known wound healing problems, as judged by the investigator.
. Active skin disease, e.g., dermatitis, psoriasis and wounds, and/or tattoos in the areas where suction blister wounds will be induced, as judged by the investigator.
. Any planned major surgery within the duration of the study.
. After 10 minutes supine rest at the time of screening, any vital signs values outside the following ranges:
. Any clinically significant abnormalities in the resting ECG at the time of screening, as judged by the Investigator.
. Current smokers or users of nicotine products. Irregular use of nicotine (e.g., smoking, snuffing, chewing tobacco) less than three times per week is allowed before screening visit.
. Female subjects who are pregnant or lactating or planning a pregnancy.
Timeframe: Day 11 in Part I (modified endpoints & timeframes in Part II & III)
8
Incidence of abnormal local reactions (Local tolerability)
Timeframe: Day 15 in Part I (modified endpoints & timeframes in Part II & III)
9
Number of patients with clinically significant changes from baseline in electrocardiogram (ECG)
Timeframe: During screening (baseline) and on day 11 in Part I (modified endpoints & timeframes in Part II & III)
10
Number of patients with clinically significant changes from baseline in vital signs.
Timeframe: During screening (baseline) and on day 11 in Part I (modified endpoints & timeframes in Part II & III)
11
Number of patients with clinically significant changes from baseline in physical examinations
Timeframe: During screening (baseline) and on day 11 in Part I (modified endpoints & timeframes in Part II & III)
12
Number of patients with clinically significant changes from baseline in safety laboratory parameters
Timeframe: During screening (baseline) and on day 2 in Part I (modified endpoints & timeframes in Part II & III)
13
Number of patients with clinically significant changes from baseline in safety laboratory parameters
Timeframe: During screening (baseline) and on day 3 in Part I (modified endpoints & timeframes in Part II & III)
14
Number of patients with clinically significant changes from baseline in safety laboratory parameters
Timeframe: During screening (baseline) and on day 5 in Part I (modified endpoints & timeframes in Part II & III)
15
Number of patients with clinically significant changes from baseline in safety laboratory parameters
Timeframe: During screening (baseline) and on day 11 in Part I (modified endpoints & timeframes in Part II & III)