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AzTrials

BlisterPhase 1NCT05378997

Safety, Tolerability, and Pharmacokinetics of Ascending Topical Doses of TCP-25 Applied to Epidermal Suction Blister Wounds, Non-Healing Leg Ulcers and Patients With Dystrophic Epidermolysis Bullosa.

A Phase 1 study of Blister and Wound of Skin, run by Xinnate AB at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a three-part, Phase I, first-in-human study designed to evaluate the safety, tolerability, and potential systemic exposure of multiple topical doses of TCP-25. Part I includes healthy volunteers with acute epidermal wounds formed by the suction blister technique. Read more about this study

Who is it for?
Ages 15 years and olderHealthy volunteers can take part
Conditions the study is for
Blister, Wound of Skin, Epidermolysis Bullosa
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
35 participants
Where
1 siteSweden
Study dates
7 Apr 2022to 16 Mar 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Willing and able to give written informed consent for participation in the study.
  • Healthy male or female subject 18-60 years (inclusive) of age at the time of signing the informed consent.
  • Body Mass Index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2.
  • Healthy and intact skin where the blister suction wounds will be induced.
  • 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.
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  • 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).
  • Clinically relevant medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator.
  • Willing and able to give written informed consent for participation in the study.
  • Male patient, or female patient of non-childbearing potential, ≥40 years of age at the time of signing the informed consent.
  • 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.
  • 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 IU/L is confirmatory).
  • Clinically relevant medical history, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator.
  • Patients diagnosed with venous insufficiency by relevant physiological tests including doppler or venous plethysmography or diagnosed by relevant clinical evaluations.
  • Systolic index > 0.6 (Data from medical records from the last 2 years, or the assessment should be repeated at the screening visit).
  • Ulcer duration > 6 weeks
  • Total target ulcer area applicable for treatment: ≤ 30 cm2 (as measured with the Silhouette imaging equipment at the screening visit). (The target ulcer area may not consist of >2 separate ulcers.)
  • Ability to tolerate compression bandaging.
  • Willing to attend study site visits.
  • 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.
  • Male or female patient with documented diagnosis of inherited DEB, ≥15 years of age at the time of signing the informed consent.
  • Male patients 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.
  • WOCBP must practice abstinence (only allowed when this is the preferred and usual lifestyle of the patient) 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 patients 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 IU/L is confirmatory).
  • Clinically relevant medical history at the time of screening, as judged by the Investigator.
  • 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:
  • Including open wound with a surface area of ≤ 30 cm2 (as measured with the Silhouette imaging equipment at the screening visit).
  • At Visit 2 (first IMP treatment), each target wound should not present a surface reduction ≥ 30 % from the Screening visit.
  • Wound aged ≥ 3 weeks to < 9 months at the Screening visit.
  • 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:
  • Including open wound with a surface area of ≤ 30 cm2 (as measured with the Silhouette imaging equipment at the screening visit).
  • At Visit 2 (first IMP treatment), the wound should not present a surface reduction ≥ 30 % from the Screening visit.
  • Wound aged ≥ 3 weeks to < 9 months at the Screening visit.
  • Not located at anatomical sites with high likelihood of accidental trauma (e.g., knee, elbow).
  • Willing to attend study site visits.

Who cannot join

  • 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.
  • 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.
  • 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.
  • Any planned major surgery within the duration of the study.
  • 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
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  • Diastolic blood pressure <50 or >100 mmHg, or
  • Pulse <40 or >90 beats per minute (bpm)
  • Any clinically significant abnormalities in the resting ECG at the time of screening, as judged by the Investigator.
  • 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.
  • Female subjects who are pregnant or lactating or planning a pregnancy.
  • Systemic immunosuppressive treatment.
  • 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
  • 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.
  • 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.
  • Planned treatment or treatment with another investigational drug within 3 months prior to Day -1.
  • History of alcohol abuse or excessive intake of alcohol, as judged by the Investigator.
  • Presence or history of drug abuse, as judged by the Investigator
  • Plasma donation within one month of screening or blood donation (or corresponding blood loss) during the three months prior to screening.
  • Involvement in the planning and/or conduct of the study.
  • Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.
  • Part II:
  • 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.
  • 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.
  • 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.
  • Any planned major surgery within the duration of the study.
  • 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)
  • Any clinically significant abnormalities in the resting ECG at the time of screening, as judged by the Investigator.
  • 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.
  • Female subjects who are pregnant or lactating or planning a pregnancy.
  • Systemic immunosuppressive treatment.
  • 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
  • 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.
  • 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.
  • Planned treatment or treatment with another investigational drug within 3 months prior to Day -1.
  • History of alcohol abuse or excessive intake of alcohol, as judged by the Investigator.
  • Presence or history of drug abuse, as judged by the Investigator.
  • Plasma donation within one month of screening or blood donation (or corresponding blood loss) during the three months prior to screening.
  • Involvement in the planning and/or conduct of the study.
  • Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.
  • 9.5.2 Part II: Exclusion criteria
  • Patients must not enter the study if any of the following exclusion criteria are fulfilled:
  • Presence or documented illness, which in the Investigator's opinion may negatively affect wound healing or interfere with the study conduct.
  • Target wound present for more than 5 years.
  • Clinical signs of infection in or around the wound in need of antibiotic treatment.
  • Albumin <25 g/L or capillary Hb <90 g/L, or HbA1c > 70 mmol/mol at the time of the screening visit.
  • Any planned major surgery within the duration of the study.
  • 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.
  • 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.
  • 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.
  • Planned treatment or treatment with another investigational drug within 3 months prior to Day -1.
  • Plasma donation within one month of screening or blood donation (or corresponding blood loss) during the three months prior to screening.
  • Involvement in the planning and/or conduct of the study.
  • Investigator considers the patient unlikely to comply with study procedures, restrictions and requirements.
  • Part III:
  • Any subtype of EB other than DEB.
  • EB index wounds that have infection in need of systemic antibiotic treatment.
  • Presence of or documented illness, which in the Investigator's opinion may negatively affect wound healing or interfere with the study conduct.
  • Subject has evidence of a systemic infection or has used systemic antibiotics for EB-related infections within 7 days before the screening visit (Visit 1).
  • 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.
  • Subject has undergone stem cell transplant or gene therapy for the treatment of EB with an effect on target wounds.
  • History of malignancy, including basal cell carcinomas or squamous cell carcinomas in the wound areas that will be included in the study.
  • 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.
  • Planned treatment or treatment with another investigational drug within 3 months prior to Day -1.
  • Involvement in the planning and/or conduct of the study.
  • Investigator considers the patient unlikely to comply with study procedures, restrictions and requirements.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Skåne University Hospital in Lund, Clinical Trial Unit

    Lund, SE-221 85

Other trials in Sweden

About this study

Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study in Healthy Male and Female Volunteers to Investigate the Safety, Tolerability, and Pharmacokinetics of Ascending Topical Doses of TCP-25 Applied to Epidermal Suction Blister Wounds and in Patients With Non-Healing Leg Ulcers and Patients With Dystrophic Epidermolysis Bullosa

This is a three-part, Phase I, first-in-human study designed to evaluate the safety, tolerability, and potential systemic exposure of multiple topical doses of TCP-25. Part I includes healthy volunteers with acute epidermal wounds formed by the suction blister technique. Part II includes patients with non-healing leg ulcers and Part III patients with dystrophic epidermolysis bullosa (DEB).

Being tested
TCP-25 gel 0.86 mg/ml or placebo gel, TCP-25 gel 2.9 mg/ml or placebo gel, TCP-25 gel 8.6 mg/ml or placebo gel
Keywords
acute epidermal wounds, suction blister, healthy volunteers
Medical subject headings
Blister, Epidermolysis Bullosa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TCP-25 gel 0.86 mg/ml or placebo gelDrug

    TCP-25 gel (0.86 mg/mL) applied to two wounds per patient and placebo gel applied to two wounds per patient

  • TCP-25 gel 2.9 mg/ml or placebo gelDrug

    TCP-25 gel (2.9 mg/mL) applied to two wounds per patient and placebo gel applied to two wounds per patient

  • TCP-25 gel 8.6 mg/ml or placebo gelDrug

    TCP-25 gel (8.6 mg/mL) applied to two wounds per patient and placebo gel applied to two wounds per patient

Study groups in NCT05378997
Study groupRoleWhat they receive
Dose group 1Experimental0.15 mL of TCP-25 gel (0.86 mg/mL) or 0.15 mL placebo gel per wound applied as topical treatment on days 1, 2, 3, 5, and 8
Receives: Drug: TCP-25 gel 0.86 mg/ml or placebo gel
Dose group 2Experimental0.15 mL of TCP-25 gel (2.9 mg/mL) or 0.15 mL placebo gel per wound applied as topical treatment on days 1, 2, 3, 5, and 8
Receives: Drug: TCP-25 gel 2.9 mg/ml or placebo gel
Dose group 3Experimental0.15 mL of TCP-25 gel (8.6 mg/mL) or 0.15 mL placebo gel per wound applied as topical treatment on days 1, 2, 3, 5, and 8
Receives: Drug: TCP-25 gel 8.6 mg/ml or placebo gel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events

    Frequency, intensity and seriousness of adverse events (AEs)

    Measured: 15 days in Part I (modified endpoints & timeframes in Part II & III)

  2. Incidence of abnormal local reactions (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

    Measured: Day 1 in Part I (modified endpoints & timeframes in Part II & III)

  3. Incidence of abnormal local reactions (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

    Measured: Day 2 in Part I (modified endpoints & timeframes in Part II & III)

  4. Incidence of abnormal local reactions (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

    Measured: Day 3 in Part I (modified endpoints & timeframes in Part II & III)

  5. Incidence of abnormal local reactions (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

    Measured: Day 5 in Part I (modified endpoints & timeframes in Part II & III)

  6. Incidence of abnormal local reactions (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

    Measured: Day 8 in Part I (modified endpoints & timeframes in Part II & III)

  7. Incidence of abnormal local reactions (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

    Measured: Day 11 in Part I (modified endpoints & timeframes in Part II & III)

  8. Incidence of abnormal local reactions (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

    Measured: Day 15 in Part I (modified endpoints & timeframes in Part II & III)

  9. Number of patients with clinically significant changes from baseline in electrocardiogram (ECG)

    Systolic and diastolic blood pressure and pulse will be measured. Any abnormalities will be specified and documented as clinically significant or not clinically significant by the investigator.

    Measured: During screening (baseline) and on day 11 in Part I (modified endpoints & timeframes in Part II & III)

  10. Number of patients with clinically significant changes from baseline in vital signs.

    Vital signs include systolic/diastolic blood pressure and pulse rate. Any vital signs outside the normal ranges will be judged as not clinically significant or clinically significant by the investigator.

    Measured: During screening (baseline) and on day 11 in Part I (modified endpoints & timeframes in Part II & III)

  11. Number of patients with clinically significant changes from baseline in physical examinations

    A physical examination will include assessments of general condition, lymph nodes, throat, heart, lungs and abdomen. Any abnormalities will be specified and documented as clinically significant or not clinically significant by the investigator.

    Measured: During screening (baseline) and on day 11 in Part I (modified endpoints & timeframes in Part II & III)

  12. Number of patients with clinically significant changes from baseline in safety laboratory parameters

    Safety laboratory parameters include haematology, clinical chemistry and coagulation. Any lab values outside the normal ranges will be judged as not clinically significant or clinically significant by the investigator.

    Haematology parameters to be measured are:

    • Haematocrit
    • Haemoglobin
    • Erythrocytes
    • Mean corpuscular volume
    • Mean corpuscular haemoglobin
    • Mean corpuscular haemoglobin concentration
    • Thrombocytes
    • Leukocytes
    • Eosinophils
    • Neutrophils
    • Basophils
    • Lymphocytes
    • Monocytes

    Clinical chemistry parameters to be measured are:

    • Alanine aminotransferase (ALT)
    • Aspartate aminotransferase (AST)
    • Creatinine
    • C-reactive protein (CRP)
    • Glucose
    • Haemoglobin A1c (HbA1C)

    Coagulation parameters to be measured are:

    • Activated partial thromboplastin time (APTT)
    • Prothrombin complex/International Normalised Ratio (PK/INR)

    Measured: During screening (baseline) and on day 2 in Part I (modified endpoints & timeframes in Part II & III)

  13. Number of patients with clinically significant changes from baseline in safety laboratory parameters

    Safety laboratory parameters include haematology, clinical chemistry and coagulation. Any lab values outside the normal ranges will be judged as not clinically significant or clinically significant by the investigator.

    Haematology parameters to be measured are:

    • Haematocrit
    • Haemoglobin
    • Erythrocytes
    • Mean corpuscular volume
    • Mean corpuscular haemoglobin
    • Mean corpuscular haemoglobin concentration
    • Thrombocytes
    • Leukocytes
    • Eosinophils
    • Neutrophils
    • Basophils
    • Lymphocytes
    • Monocytes

    Clinical chemistry parameters to be measured are:

    • Alanine aminotransferase (ALT)
    • Aspartate aminotransferase (AST)
    • Creatinine
    • C-reactive protein (CRP)
    • Glucose
    • Haemoglobin A1c (HbA1C)

    Coagulation parameters to be measured are:

    • Activated partial thromboplastin time (APTT)
    • Prothrombin complex/International Normalised Ratio (PK/INR)

    Measured: During screening (baseline) and on day 3 in Part I (modified endpoints & timeframes in Part II & III)

  14. Number of patients with clinically significant changes from baseline in safety laboratory parameters

    Safety laboratory parameters include haematology, clinical chemistry and coagulation. Any lab values outside the normal ranges will be judged as not clinically significant or clinically significant by the investigator.

    Haematology parameters to be measured are:

    • Haematocrit
    • Haemoglobin
    • Erythrocytes
    • Mean corpuscular volume
    • Mean corpuscular haemoglobin
    • Mean corpuscular haemoglobin concentration
    • Thrombocytes
    • Leukocytes
    • Eosinophils
    • Neutrophils
    • Basophils
    • Lymphocytes
    • Monocytes

    Clinical chemistry parameters to be measured are:

    • Alanine aminotransferase (ALT)
    • Aspartate aminotransferase (AST)
    • Creatinine
    • C-reactive protein (CRP)
    • Glucose
    • Haemoglobin A1c (HbA1C)

    Coagulation parameters to be measured are:

    • Activated partial thromboplastin time (APTT)
    • Prothrombin complex/International Normalised Ratio (PK/INR)

    Measured: During screening (baseline) and on day 5 in Part I (modified endpoints & timeframes in Part II & III)

  15. Number of patients with clinically significant changes from baseline in safety laboratory parameters

    Safety laboratory parameters include haematology, clinical chemistry and coagulation. Any lab values outside the normal ranges will be judged as not clinically significant or clinically significant by the investigator.

    Haematology parameters to be measured are:

    • Haematocrit
    • Haemoglobin
    • Erythrocytes
    • Mean corpuscular volume
    • Mean corpuscular haemoglobin
    • Mean corpuscular haemoglobin concentration
    • Thrombocytes
    • Leukocytes
    • Eosinophils
    • Neutrophils
    • Basophils
    • Lymphocytes
    • Monocytes

    Clinical chemistry parameters to be measured are:

    • Alanine aminotransferase (ALT)
    • Aspartate aminotransferase (AST)
    • Creatinine
    • C-reactive protein (CRP)
    • Glucose
    • Haemoglobin A1c (HbA1C)

    Coagulation parameters to be measured are:

    • Activated partial thromboplastin time (APTT)
    • Prothrombin complex/International Normalised Ratio (PK/INR)

    Measured: During screening (baseline) and on day 11 in Part I (modified endpoints & timeframes in Part II & III)

Secondary outcomes (4)

  1. Plasma concentration of TCP-25

    Measurement of TCP-25 concentration in plasma

    Measured: Day 1 (measured before blister formation) in Part I (modified endpoints & timeframes in Part II & III)

  2. Plasma concentration of TCP-25

    Measurement of TCP-25 concentration in plasma

    Measured: Day 2 (measured before administration of the intervention and 0.5 and 1 hours after administration of the intervention) in Part I (modified endpoints & timeframes in Part II & III)

  3. Plasma concentration of TCP-25

    Measurement of TCP-25 concentration in plasma

    Measured: Day 3 (measured before administration of the intervention 1 hour after administration of the intervention) in Part I (modified endpoints & timeframes in Part II & III)

  4. Plasma concentration of TCP-25

    Measurement of TCP-25 concentration in plasma

    Measured: Day 5 (measured before administration of intervention) in Part I (modified endpoints & timeframes in Part II & III)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2022
  2. Study start7 Apr 2022
  3. Primary completion16 Mar 2024
  4. Study completion16 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Part I: Multiple topical doses of TCP-25 will be administered in 3 sequential dose groups, each of 8 subjects. Within each cohort, the subjects will receive TCP-25 on one wound on each thigh and placebo on one wound on each thigh in a randomized fashion as topical treatment. In Part II: Multiple topical doses of TCP-25 will be administered to 6 patients with non-healing leg ulcers. In Part III: Up to 4 dose levels of TCP-25 will be administered in up to 5 patients with DEB by topical application of TCP-25 gel of two concentrations.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05378997
Sponsor's protocol ID
TCP-25-001
Other IDs
2021-004728-14
Status last verified
Mar 2024
First submitted
25 Apr 2022
Last updated
26 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Publication of the study results and access to the study data is at the discretion of the Sponsor. It may be made available upon reasonable request.

Publications

  • Wallblom K, Lundgren S, Petruk G, Puthia M, Fisher J, Hugerth M, Saleh K, Schmidtchen A. A First-In-Human Randomized Controlled Phase 1 Study Assessing the Safety and Tolerability of Topical TCP-25 Gel in Epidermal Suction Blister Wounds. Clin Transl Sci. 2026 Feb;19(2):e70497. doi: 10.1111/cts.70497.

    PubMed 41645556

  • Wallblom K, Holmgren K, Lundgren S, Belfrage E, Hoppe T, Hugerth M, Lindqvist AK, Sonkoly E, Schmidtchen A. Results of a non-randomized, open-label phase I study evaluating the novel immunomodulatory peptide TCP-25 for treatment of dystrophic epidermolysis bullosa. Orphanet J Rare Dis. 2025 Dec 2;21(1):4. doi: 10.1186/s13023-025-04156-7.

    PubMed 41327356

  • Wallblom K, Forsberg F, Lundgren S, Fisher J, Cardoso J, Petruk G, Stromdahl AC, Saleh K, Puthia M, Schmidtchen A. Bactogram: Spatial Analysis of Bacterial Colonisation in Epidermal Wounds. Exp Dermatol. 2024 Dec;33(12):e70018. doi: 10.1111/exd.70018.

    PubMed 39627888

  • Lundgren S, Wallblom K, Fisher J, Erdmann S, Schmidtchen A, Saleh K. Study protocol for a phase 1, randomised, double-blind, placebo-controlled study to investigate the safety, tolerability and pharmacokinetics of ascending topical doses of TCP-25 applied to epidermal suction blister wounds in healthy male and female volunteers. BMJ Open. 2023 Feb 22;13(2):e064866. doi: 10.1136/bmjopen-2022-064866.

    PubMed 36813496

Questions about this trial

What is this clinical trial studying?

A Phase 1 study of Blister and Wound of Skin, run by Xinnate AB at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 36 inclusion and 74 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (time frame: 15 days in Part I (modified endpoints & timeframes in Part II & III)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05378997, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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