Trial to Investigate GZ21T in Healthy Volunteers (NCT06888362) | Clinical Trial Compass
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 range
18 Years – 70 Years
Sex
ALL
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
AE
Timeframe: Day 1 to Day 7
2
Number of Reported Skin Reactions
Timeframe: Day 1 to Day 7.
3
Number of Participants With Clinically Significant Changes in Vital Signs
Timeframe: Day 1 to Day 7.
4
Number of Participants With Clinically Significant Changes in Electrocardiograms (ECGs)
Timeframe: Day 1 to Day 7.
5
Number of Participants With Clinically Significant Abnormal Laboratory Test Results (Haematology, Clinical Chemistry, Coagulation)
Timeframe: Day 1 to Day 7.
6
Number of Participants With Clinically Significant Changes in Physical Examination Findings.
Timeframe: Day 1 to Day 7.
7
Amount of Cream Absorbed After Single Dose Applications.
. 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.