Safety, Tolerability, and Pharmacokinetics of Ascending Topical Doses of TCP-25 Applied to Epidermal Suction Blister Wounds

• Status: Recruiting
• Trial end date: 2022-06-20
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase I, double-blind, placebo-controlled, randomized first-in-human study including healthy volunteers with acute epidermal wounds formed by the suction blister technique designed to evaluate the safety, tolerability, and potential systemic exposure of multiple topical doses of TCP-25.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Xinnate AB
• Collaborator: Region Skane

Criteria

Inclusion Criteria:

1. Willing and able to give written informed consent for participation in the study.

2. Healthy male or female subject 18-60 years (inclusive) of age at the time of signing the informed consent.

3. Body Mass Index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2.

4. Healthy and intact skin where the blister suction wounds will be induced.

5. 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.

WOCBP must practice abstinence (only allowed when this is the preferred and usual lifestyle of the subject) or must agree to use a highly effective method of contraception with a failure rate of < 1% to prevent pregnancy (combined [oestrogen and progestogen containing] hormonal contraception associated with inhibition of ovulation [oral, intravaginal, transdermal], progestogen-only hormonal contraception associated with inhibition of ovulation [oral, injectable, implantable], intrauterine device [IUD] or intrauterine hormone-releasing system [IUS]) from at least 4 weeks prior to dose to 4 weeks after last dose. Female subjects must refrain from donating eggs from the date of dosing until 3 months after dosing with the IMP. Their male partner must agree to use a condom during the same time frame if he has not undergone vasectomy.

Women of non-childbearing potential are defined as pre-menopausal females who are sterilised (tubal ligation or permanent bilateral occlusion of fallopian tubes); or females who have undergone hysterectomy or bilateral oophorectomy; or post-menopausal defined as 12 months of amenorrhea (in questionable cases a blood sample with detection of follicle stimulating hormone [FSH] 25-140 IE/L is confirmatory).

Male subjects must be willing to use condom or be vasectomised or practice sexual abstinence to prevent pregnancy and drug exposure of a partner and refrain from donating sperm from the date of last dosing until 3 months after the last dosing with the IMP. Their female partner of child-bearing potential must use contraceptive methods with a failure rate of < 1% to prevent pregnancy (see above).

6. Clinically relevant medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator.

Exclusion Criteria:

1. 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.

2. 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.

3. 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.

4. Any planned major surgery within the duration of the study.

5. After 10 minutes supine rest at the time of screening, any vital signs values outside the following ranges:

• Systolic blood pressure <90 or >160 mmHg, or

• Diastolic blood pressure <50 or >100 mmHg, or

• Pulse <40 or >90 beats per minute (bpm)

6. Any clinically significant abnormalities in the resting ECG at the time of screening, as judged by the Investigator.

7. 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.

8. Female subjects who are pregnant or lactating or planning a pregnancy.

9. Systemic immunosuppressive treatment.

10. Subjects who are currently receiving or have received the following treatments within 2 weeks prior to screening are excluded from the study: - systemic corticosteroids or immunosuppressant agents; or - antibiotics via any route

11. Regular use of anticoagulants (i.e., heparin, warfarin, coumarins, other anticoagulants per Investigator's judgement) or non-steroidal anti-inflammatory drugs (NSAIDs) within 2 weeks prior to the (first) administration of IMP, at the discretion of the Investigator.

12. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to TCP-25 or to any excipients of the hydrogel.

13. Planned treatment or treatment with another investigational drug within 3 months prior to Day -1.

14. History of alcohol abuse or excessive intake of alcohol, as judged by the Investigator.

15. Presence or history of drug abuse, as judged by the Investigator

16. Plasma donation within one month of screening or blood donation (or corresponding blood loss) during the three months prior to screening.

17. Involvement in the planning and/or conduct of the study.

18. Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.