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    Summary
    EudraCT Number:2021-004728-14
    Sponsor's Protocol Code Number:TCP25-001
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-11-16
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSweden - MPA
    A.2EudraCT number2021-004728-14
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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
    A.4.1Sponsor's protocol code numberTCP25-001
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorXinnate AB
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportXinnate AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCTC Clinical Trial Consultants AB
    B.5.2Functional name of contact pointCRM
    B.5.3 Address:
    B.5.3.1Street AddressDag Hammarskjöldsväg 10 B
    B.5.3.2Town/ cityUppsala
    B.5.3.3Post code75237
    B.5.3.4CountrySweden
    B.5.6E-mailcaroline.hammarstrom@ctc-ab.se
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTCP-25
    D.3.2Product code TCP-25
    D.3.4Pharmaceutical form Transdermal gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTCP-25
    D.3.9.2Current sponsor codeTCP-25
    D.3.9.3Other descriptive nameH-Gly-Lys-Tyr-Gly-Phe-Tyr-Thr-His-Val-Phe-Arg-Leu-Lys-Lys-Trp-Ile-Gln-Lys-Val-Ile-Asp-Gln-Phe-Gly-Glu-OH
    D.3.9.4EV Substance CodeSUB245389
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.86 to 8.6
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTransdermal gel
    D.8.4Route of administration of the placeboTopical
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    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.
    E.1.1.1Medical condition in easily understood language
    Treatment is to be given to patients with XYZ to promote wound healing.
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    E.2.2Secondary objectives of the trial
    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.
    E.2.3Trial contains a sub-study No
    E.3Principal 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 prevent pregnancy
    4.Clinically relevant medical history at the time of screening, as judged by the Investigator
    5.Presence of two target wound areas of 50 cm2.The primary wound area should not be located at anatomical sites with high likelihood of accidental trauma (e.g., knee, elbow).The secondary wound area could be located at anatomical sites with high likelihood of accidental trauma or be within the higher age span. Both wound areas should meet all the following characteristics:
    a.Including open wound with a surface area of ≤ 30 cm2 (as measured with the Silhouette imaging equipment at the screening visit).
    b.At Visit 2 (first IMP treatment), each target wound should not present a surface reduction ≥ 30 % from the Screening visit
    c.Wound aged ≥ 3 weeks to < 9 months at the Screening visit
    6.Presence of a reference wound area of 50 cm2 to be treated with standard of care only and to be included in the exploratory assessment. The wound area should match the primary wound area for following characteristics:
    a.Including open wound with a surface area of ≤30 cm2 (as measured with the Silhouette imaging equipment at the screening visit).
    b.At Visit 2 (first IMP treatment), the wound should not present a surface reduction ≥ 30 % from the Screening visit
    c.Wound aged ≥3 weeks to <9 months at the Screening visit
    d.Not located at anatomical sites with high likelihood of accidental trauma (e.g., knee, elbow)
    7.Willing to attend study site visits
    E.4Principal 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 similar chemical structure or class to TCP-25 or to any excipients of the hydrogel.

    Part 3
    1.Any subtype of XYZ other than XYZ.
    2.XYZ index wounds that have infection in need of systemic antibiotic treatment.
    3.Presence of or documented illness, which in the Investigator’s opinion may negatively affect wound healing or interfere with the study conduct.
    4.Subject has evidence of a systemic infection or has used systemic antibiotics for XYZ-related infections within 7 days before the screening visit (Visit 1).
    5.Administration of systemic corticosteroids within 30 days (> 10 mg daily of prednisolone or corresponding) or of topical corticosteroids on target wound areas (primary, secondary and reference wound areas) within 14 days before the screening visit (Visit 1). Corticosteroids for inhalation, ophthalmic, or intranasal use are permitted.
    6.Subject has undergone stem cell transplant or gene therapy for the treatment of XYZ with an effect on target wounds.
    7.History of malignancy, including basal cell carcinomas or squamous cell carcinomas in the wound areas that will be included in the study.
    8.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.
    9.Planned treatment or treatment with another investigational drug within 3 months prior to Day -1.

    E.5 End points
    E.5.1Primary 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 local reactions as compared to baseline , by direct assessment by Investigator :
    - Peri-wound and open wound erythema of treated area (abnormal reaction noted)
    - Peri-wound and open wound oedema and swelling of treated area (abnormal reaction noted)
    - Peri-wound and open wound scaling of treated area (abnormal reaction noted)
    - Peri-wound and open wound stinging/burning of treated area (abnormal reaction noted)




    E.5.1.1Timepoint(s) of evaluation of this end point
    Through-out the study period
    E.5.2Secondary 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
    E.5.2.1Timepoint(s) of evaluation of this end point
    Through-out the study period
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Part 1= controlled, randomised and double blind. Part 2 and 3 = open
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial5
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the study is defined as the date of the last visit of the last subject in the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 5
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 5
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state35
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-02-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-10
    P. End of Trial
    P.End of Trial StatusOngoing
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