A Three-part, Phase I Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of Topical Doses of TCP-25 in Healthy Male and Female Volunteers with Epidermal Suction Blister Wounds and in Patients with Non-Healing Leg Ulcers and Patients with XYZ

Phase 1

Active, not recruiting

• Conditions: TCP-25 gel targets both bacteria and inflammation, aspects common to many wounds and is being developed for a range of wound healing indications including prevention and treatment of infection and inflammation in XYZ and in other acute or non-healing wounds.; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2021-004728-14-SE
• Lead Sponsor: Xinnate AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-16
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Part 1
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 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. 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
6.Clinically relevant medical history, physical findings,vital signs,ECG and laboratory values at the time of screening, as judged by the Investigator

Part 2:
1.Willing and able to give written informed consent for participation in the study
2.Male patient, or female patient of non-childbearing potential, =40 years of age at the time of signing the informed consent.
3.Male subjects must be willing to use condom or be vasectomized 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.
4.Clinically relevant medical history,vital signs,ECG and laboratory values at the time of screening, as judged by the Investigator.
5.Patients diagnosed with venous insufficiency by relevant physiological tests including doppler or venous plethysmography or diagnosed by relevant clinical evaluations.
6.Systolic index > 0.6 (Data from medical records from the last 2 years, or the assessment should be repeated at the screening visit)
7.Ulcer duration > 6 weeks
8.Total target ulcer area applicable for treatment: = 40 and = 120 cm2 (as measured with the Silhouette imaging equipment at the screening visit). (The target ulcer area may not consist of >2 separate ulcers)
9.Ability to tolerate compression bandaging
10.Willing to attend study site visits

Part 3
1.Willing and able to give written informed consent for participation in the study.For 15 to 17-year-olds: A separate consent is required from both (if applicable) the patient’s parents/legal guardians
2.Male patient,or female patient of non-childbearing potential with documented diagnosis of inherited XYZ, =15 years of age at the time of signing the informed consent.
3.Male subjects must be willing to use condom or be vasectomized 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 p

Exclusion Criteria

Part 1:
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.
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

Part 2:
1.Presence or documented illness, which in the Investigator’s opinion may negatively affect wound healing or interfere with the study conduct.
2.Target wound present for more than 5 years.
3.Clinical signs of infection in or around the wound in need of antibiotic treatment.
4.Albumin <25 g/L or capillary Hb <90 g/L, or HbA1c > 70 mmol/mol at the time of the screening visit.
5.Any planned major surgery within the duration of the study.
6.Patients who are currently receiving or have received the following treatments within 2 weeks prior to screening are excluded from the study:
- systemic corticosteroids above 5 mg prednisolone or equivalent, or
- immunosuppressant agents; or
- antibiotics via any route.
7.Regular use of anticoagulants (i.e., heparin, warfarin, coumarins, other anticoagulants affecting APTT and/or PK/INR per Investigator’s judgement) within 2 weeks prior to the (first) administration of IMP, at the discretion of the Investigator.
8.History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a simi

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified