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 range15 Years

SexALL

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

✕. 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.

What they're measuring

Adverse Events

Timeframe: 15 days in Part I (modified endpoints & timeframes in Part II & III)

Incidence of abnormal local reactions (Local tolerability)

Timeframe: Day 1 in Part I (modified endpoints & timeframes in Part II & III)

Incidence of abnormal local reactions (Local tolerability)

Timeframe: Day 2 in Part I (modified endpoints & timeframes in Part II & III)

Incidence of abnormal local reactions (Local tolerability)

Timeframe: Day 3 in Part I (modified endpoints & timeframes in Part II & III)

Incidence of abnormal local reactions (Local tolerability)

Timeframe: Day 5 in Part I (modified endpoints & timeframes in Part II & III)

Incidence of abnormal local reactions (Local tolerability)

Timeframe: Day 8 in Part I (modified endpoints & timeframes in Part II & III)

Incidence of abnormal local reactions (Local tolerability)

Timeframe: Day 11 in Part I (modified endpoints & timeframes in Part II & III)

Trial details

NCT IDNCT05378997

SponsorXinnate AB

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-16

View on ClinicalTrials.gov More Blister trials

Plain-language summary

Who can participate

Age range15 Years

SexALL

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

✕. 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.

What they're measuring

Adverse Events

Timeframe: 15 days in Part I (modified endpoints & timeframes in Part II & III)

Incidence of abnormal local reactions (Local tolerability)

Timeframe: Day 1 in Part I (modified endpoints & timeframes in Part II & III)

Incidence of abnormal local reactions (Local tolerability)

Timeframe: Day 2 in Part I (modified endpoints & timeframes in Part II & III)

Incidence of abnormal local reactions (Local tolerability)

Timeframe: Day 3 in Part I (modified endpoints & timeframes in Part II & III)

Incidence of abnormal local reactions (Local tolerability)

Timeframe: Day 5 in Part I (modified endpoints & timeframes in Part II & III)

Incidence of abnormal local reactions (Local tolerability)

Timeframe: Day 8 in Part I (modified endpoints & timeframes in Part II & III)

Incidence of abnormal local reactions (Local tolerability)

Timeframe: Day 11 in Part I (modified endpoints & timeframes in Part II & III)