Trial to Investigate GZ21T in Healthy Volunteers

Launched by GENZADA PHARMACEUTICALS USA, INC. · Mar 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called GZ21T, which is being tested on healthy volunteers to see how safe it is and how well it works when applied to the skin. The trial is designed to ensure that the treatment is tolerable and to understand how it behaves in the body after a single use. If you are between 18 and 70 years old and generally healthy, you might be eligible to participate. Key requirements include being within a specific weight range and agreeing to certain precautions regarding pregnancy and contraception.

Participants in the trial will receive either the treatment or a placebo (a non-active version) without knowing which one they got. They will be monitored closely for any side effects and how their body responds to the treatment. It's important to note that individuals with certain medical conditions, recent surgeries, or specific skin issues may not qualify. This trial is an opportunity to help advance research on actinic keratosis while contributing to the understanding of this new treatment.

Gender

ALL

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.