Investigating GZ21T in Healthy Volunteers

A Double-blind, Randomised, Placebo-controlled Phase I Trial to Investigate Safety, Tolerability and Pharmacokinetics of Single Ascending Topical Doses of GZ21T in Healthy Volunteers

This study is testing a new topical treatment called GZ21T on healthy volunteers to see how safe it is and how the body processes it compared to a placebo.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Genzada Pharmaceuticals USA, Inc. (Industry-sponsored)
• Locations: 1 site (Uppsala)
• Trial ID: NCT06888362 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety, tolerability, and pharmacokinetics of GZ21T through a double-blind, randomized, placebo-controlled approach. Healthy volunteers will receive a single topical application of GZ21T or a placebo across various body surface areas. Participants will undergo monitoring for safety assessments and pharmacokinetic evaluations over three clinic visits. The study aims to gather data on the effects of GZ21T in a controlled environment.

Who should consider this trial

Good fit: Ideal candidates are healthy males and females aged 18 to 70 with a BMI between 18.5 and 30.0.

Not a fit: Patients with existing skin conditions or those who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a new treatment option for actinic keratosis.

How similar studies have performed: While this approach is being tested in this specific context, similar studies have shown promise in evaluating topical treatments for skin conditions.

Eligibility criteria

Inclusion Criteria:

1. Willing and able to give written informed consent for participation in the trial.
2. Healthy male or female participant aged 18 to 70 years, inclusive.
3. Body Mass Index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 at the time of the screening visit.
4. 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.

WOCBP must refrain from donating eggs from the first IMP administration until 3 months after the last IMP administration.

Exclusion Criteria:

1. 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.
2. Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the administration of IMP.
3. 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.
4. Malignancy within the past 5 years, including removal of basal cell carcinoma.
5. Any planned major surgery within the duration of the trial.
6. Any skin condition including tattoos that may limit the evaluation of e.g., local tolerability as judged by the Investigator.
7. History of chronic urticaria, known history of urticaria triggered by specific factors or currently experiencing an episode of urticaria within the past 3 months.
8. History of psoriasis, atopic eczema and similar conditions, as judged by the Investigator.
9. Prescence of body hair or tattoos on the intended application areas, which in the opinion of the Investigator could interfere with local tolerability assessments.
10. Females who are pregnant, currently breastfeeding, or intend to become pregnant during the course of the trial.
11. Any positive result at the screening visit for serum hepatitis B surface antigen, hepatitis B and C antibodies and/or human immunodeficiency virus (HIV).
12. After 10 minutes of supine rest at the screening visit, any vital signs values outside the following ranges: - Systolic blood pressure: \<90 or ≥140 mmHg, or - Diastolic blood pressure \<50 or ≥90 mmHg, or - Pulse \<40 or \>90 bpm
13. Prolonged QTcF (\>450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG at the screening visit, as judged by the Investigator.
14. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs or food with a similar chemical structure or class to GZ21T.
15. Regular use of any prescribed or non-prescribed medications, including antacids, analgesics, herbal remedies, within 2 weeks prior to the (first) administration of IMP, except occasional intake of paracetamol (maximum 2000 mg/day and not exceeding 3000 mg/week), as well as nasal decongestants without cortisone, antihistamine, or anticholinergics for a maximum of 10 days, at the discretion of the Investigator.
16. Unwillingness to abstain from the use of topical treatment (including but not limited to corticosteroids, calcineurin inhibitors, vitamin D analogues, and retinoids) at the application site within 1 week prior to Day 1 and from the use of moisturising ointment cream, emollients, oils (including shower oil) or sunscreen within 24 hours prior to Day 1 until 1 week after IMP administration.
17. Planned treatment or treatment with another investigational drug within 3 months prior to Day 1. Participants who consented and screened but were not dosed in previous clinical trials are not to be excluded.
18. Current smokers or users of nicotine products. Irregular use of nicotine (e.g., smoking, snuffing, chewing tobacco) less than 3 times per week is allowed before screening visit.
19. Positive screening result for drugs of abuse or alcohol at the screening visit or on admission to the trial site prior to the administration of the IMP. (Positive results that are expected given the participant's medical history and prescribed medications can be disregarded as judged by the Investigator.)
20. History of alcohol abuse or excessive intake of alcohol, history or presence of drug abuse including anabolic steroids, as judged by the Investigator.
21. Plasma donation within approximately 1 month of screening or blood donation (or corresponding blood loss) during the last 3 months prior to screening, at the discretion of the Investigator.
22. The Investigator considers the participant unlikely to comply with trial procedures, restrictions and requirements.

Where this trial is running

Uppsala

• CTC (Clinical Trial Consultants) AB — Uppsala, Sweden (Recruiting)

Study contacts

• Study coordinator: Cameron West

Conditions Actinic Keratosis; Actinic keratosis