CompletedPhase 1

Trial to Investigate GZ21T in Healthy Volunteers

Sweden41 participantsStarted 2024-08-19

Plain-language summary

This is a double-blind, randomised, placebo-controlled trial designed to evaluate safety, tolerability, and pharmacokinetics (PK) after topical administration of single ascending doses of GZ21T in healthy volunteers.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Willing and able to give written informed consent for participation in the trial.
✓. Healthy male or female participant aged 18 to 70 years, inclusive.
✓. Body Mass Index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 at the time of the screening visit.
✓. WOCBP must practice abstinence from heterosexual intercourse (only allowed when this is the preferred and usual lifestyle of the participant) or must agree to use a highly effective method of contraception with a failure rate of \<1 % to prevent pregnancy from at least 2 weeks prior to the administration of IMP to 4 weeks after the last administration of IMP. In addition, any male partner of a female participant must, unless he is sterile (e.g., has undergone vasectomy), agree to use a condom from the first administration of IMP until 4 weeks after the last administration of IMP.

Exclusion criteria

✕. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial or influence the results or the participant's ability to participate in the trial.
✕. Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the administration of IMP.
✕. Any clinically significant abnormalities regarding physical examination, vital signs, 12- lead ECG, and laboratory values at the time of the screening visit, as judged by the Investigator.
✕. Malignancy within the past 5 years, including removal of basal cell carcinoma.
✕. Any planned major surgery within the duration of the trial.
✕. Any skin condition including tattoos that may limit the evaluation of e.g., local tolerability as judged by the Investigator.
✕. History of chronic urticaria, known history of urticaria triggered by specific factors or currently experiencing an episode of urticaria within the past 3 months.
✕. History of psoriasis, atopic eczema and similar conditions, as judged by the Investigator.

What they're measuring

Timeframe: Day 1 to Day 7

Number of Reported Skin Reactions

Timeframe: Day 1 to Day 7.

Number of Participants With Clinically Significant Changes in Vital Signs

Timeframe: Day 1 to Day 7.

Number of Participants With Clinically Significant Changes in Electrocardiograms (ECGs)

Timeframe: Day 1 to Day 7.

Number of Participants With Clinically Significant Abnormal Laboratory Test Results (Haematology, Clinical Chemistry, Coagulation)

Timeframe: Day 1 to Day 7.

Number of Participants With Clinically Significant Changes in Physical Examination Findings.

Timeframe: Day 1 to Day 7.

Amount of Cream Absorbed After Single Dose Applications.

Timeframe: 0-2 hours after IMP administration

Trial details

NCT IDNCT06888362

SponsorGenzada Pharmaceuticals USA, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-31

Results submitted2025-12-05

View on ClinicalTrials.gov More Actinic Keratosis trials

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Willing and able to give written informed consent for participation in the trial.
✓. Healthy male or female participant aged 18 to 70 years, inclusive.
✓. Body Mass Index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 at the time of the screening visit.
✓. WOCBP must practice abstinence from heterosexual intercourse (only allowed when this is the preferred and usual lifestyle of the participant) or must agree to use a highly effective method of contraception with a failure rate of \<1 % to prevent pregnancy from at least 2 weeks prior to the administration of IMP to 4 weeks after the last administration of IMP. In addition, any male partner of a female participant must, unless he is sterile (e.g., has undergone vasectomy), agree to use a condom from the first administration of IMP until 4 weeks after the last administration of IMP.

Exclusion criteria

✕. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial or influence the results or the participant's ability to participate in the trial.
✕. Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the administration of IMP.
✕. Any clinically significant abnormalities regarding physical examination, vital signs, 12- lead ECG, and laboratory values at the time of the screening visit, as judged by the Investigator.
✕. Malignancy within the past 5 years, including removal of basal cell carcinoma.
✕. Any planned major surgery within the duration of the trial.
✕. Any skin condition including tattoos that may limit the evaluation of e.g., local tolerability as judged by the Investigator.
✕. History of chronic urticaria, known history of urticaria triggered by specific factors or currently experiencing an episode of urticaria within the past 3 months.
✕. History of psoriasis, atopic eczema and similar conditions, as judged by the Investigator.

What they're measuring

Timeframe: Day 1 to Day 7

Number of Reported Skin Reactions

Timeframe: Day 1 to Day 7.

Number of Participants With Clinically Significant Changes in Vital Signs

Timeframe: Day 1 to Day 7.

Number of Participants With Clinically Significant Changes in Electrocardiograms (ECGs)

Timeframe: Day 1 to Day 7.

Number of Participants With Clinically Significant Abnormal Laboratory Test Results (Haematology, Clinical Chemistry, Coagulation)

Timeframe: Day 1 to Day 7.

Number of Participants With Clinically Significant Changes in Physical Examination Findings.

Timeframe: Day 1 to Day 7.

Amount of Cream Absorbed After Single Dose Applications.

Timeframe: 0-2 hours after IMP administration