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.
Conditions
Interventions
Product Name: TCP-25
Product Code: TCP-25
Pharmaceutical Form: Transdermal gel
INN or Proposed INN: TCP-25
Current Sponsor code: TCP-25
Other descriptive name: H-Gly-Lys-Tyr-Gly-Phe-Tyr-Thr-His-Val-Ph
Sponsors
Xinnate AB
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
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 160 mmHg, or •Diastolic blood pressure 100 mmHg, or •Pulse 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part 1: The primary objective is to evaluate the safety and tolerability of three dose levels of TCP-25 gel (0.86 mg/mL, 2.9 mg/ml and 8.6 mg/mL) applied topically to epidermal suction blister wounds. Part 2: The primary objective is to evaluate the safety and tolerability of two doses of TCP-25 gel (2.9 mg/mL and 8.6 mg/mL) after applied topically to non-healing leg ulcers. Part 3: The primary objective is to evaluate the safety and tolerability of up to four dose levels of TCP-25 applied by two strengths of TCP-25 gel (2.9 mg/mL and 8.6 mg/mL, respectively) topically to patients with XYZ.;Secondary Objective: Part 1: The secondary objective is to evaluate the systemic exposure of TCP-25 after applied topically to epidermal suction blister wounds. Part 2: The secondary objective is to evaluate the systemic exposure of TCP-25 after applied topically to non-healing leg ulcers. Part 3: The secondary objective is to evaluate the systemic exposure of TCP-25 when applied topically in up to four dose levels by two strengths of TCP-25 gel (2.9 mg/mL and 8.6 mg/mL) topically to patients with XYZ.;Primary end point(s): Part 1 and 2: •Frequency, intensity and seriousness of adverse events (AEs). •Local tolerability: Incidence of abnormal local reactions as compared to expected wound healing outcome, by direct assessment by Investigator: -Skin and wound erythema (abnormal reaction noted). -Skin and wound oedema and swelling (abnormal reaction noted). -Wound necrosis, crusting, and hemorrhage (abnormal reactions noted). -Wound purulent discharge as sign of excessive bacterial colonization and/or infection. •Clinically significant changes from baseline in electrocardiogram (ECG), vital signs (systolic/diastolic blood pressure, pulse rate), safety laboratory parameters (haematology, clinical chemistry and coagulation) and physical examinations. Part 3 •Frequency, intensity and seriousness of adverse events (AEs). •Local tolerability: Incidence of abnormal | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Part 1: TCP-25 plasma concentrations as measured at Day 1, Day 2, Day 3 and Day 5. Part 2: TCP-25 plasma concentrations as measured at Day 8, 12, 15, 19, 22, 26 29 (optional), and 33 (optional). Part 3: TCP-25 plasma concentrations as measured at Day 22;Timepoint(s) of evaluation of this end point: Through-out the study period | — |
Countries
Sweden
Contacts
Public ContactCRM
CTC Clinical Trial Consultants AB
Outcome results
None listed