To Evaluate the Adhesion of TK-254RX on Healthy Participants (NCT07307794) | Clinical Trial Compass
RecruitingPhase 1
To Evaluate the Adhesion of TK-254RX on Healthy Participants
Germany90 participantsStarted 2026-01-19
Plain-language summary
This study is a single-center, open-label, multiple-dose trial in healthy participants. The primary purpose of this study is to assess the adhesion of TK-254RX. Secondary purposes are to assess the safety of TK-254RX and the residual amount of the patch.
Who can participate
Age range18 Years – 64 Years
SexALL
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Inclusion Criteria:
* age: 18 to 64 years
* good state of health
* written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the participants enrolled in the clinical trial
Exclusion Criteria:
* any injury of body which may induce the restriction of body movement
* excessively hairy skin at application site
* current or anamnestic known skin disorder (e.g., atopic dermatitis (eczema), neurodermatitis, contact allergy, psoriasis, vitiligo, melanoma, squamous cell carcinoma) or shaving hair at application site, which might interfere with the safety or tolerability of the active ingredient
* history of excessive sweating/hyperhidrosis inclusive of application site
* participation in a clinical study within 30 days before inclusion in the study or concomitantly
* drug or alcohol abuse in the opinion of the investigator
* pregnant and lactating women
* women of child-bearing potential (WOCBP) who do not agree to apply highly effective contraceptive methods
* Surgical sterilization
* Hormonal contraception: combined (estrogen and progestogen containing) hormonal contraception, e.g., oral, intravaginal, transdermal, and progestogen-only hormonal contraception e.g. oral, injectable, implantable as well as intrauterine device (IUD) and intrauterine hormone-releasing system (IUS) each in combination with male condom to increase safety effect (double barrier method))
* B…