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Trial to Investigate GZ21T in Healthy Volunteers | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Trial to Investigate 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

NCT06888362•Genzada Pharmaceuticals USA, Inc.

View on ClinicalTrials.gov

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.

Detailed Description

Participants will receive a single topical application of GZ21T or placebo: Part A: * Cohort 1: 25.5 mg/cm2 GZ21T or placebo will be applied to 900 cm2 of the skin, corresponding to approximately 5% body surface area (BSA) and 23 g cream. * Cohort 2: 25.5 mg/cm2 GZ21T or placebo will be applied to 1350 cm2 of the skin, corresponding to approximately 7.5% BSA and 35 g cream. * Cohort 3: 25.5 mg/cm2 GZ21T or placebo will be applied to 1800 cm2 of the skin, corresponding to approximately 10% BSA and 46 g cream. * Cohort 4: 25.5 mg/cm2 GZ21T or placebo will be applied to the face, corresponding to approximately 3-3.5% BSA (540 - 630% cm2) and 16 g cream. Participants will come for 3 visits to the research clinic for screening, treatment, and follow-up. Sentinel dosing will be applied. All participants will be carefully monitored by clinical staff during and after IMP application and will remain at the research clinic for at least 24 hours after treatment (Day 2) for safety assessments, including safety laboratory testing, 12-lead ECG, vital signs, local tolerability, physical examination and AEs, and PK assessments. Part B: * Cohort 1: 13 mg/cm2 GZ21T will be applied to 900 cm2 of the skin, corresponding to approximately 5% body surface area (BSA) * Optional cohorts 2 and 3: A single dose of GZ21T decided based on the results from preceding cohorts will be applied to 900 cm2 of the skin corresponding to approximately 5% BSA. Participants will come for 3 visits to the research clinic and 1 telephone visit for screening, treatment, and follow-up. All participants will be carefully monitored by clinical staff during and after IMP application and will remain at the research clinic for 2 hours after treatment for local tolerability and AE evaluation. On Day 2 (Visit 3), approximately 24 hours post-dose, participants will visit the research clinic for follow-up of local tolerability and AEs. A remote telephone call will be performed on Day 7 (Visit 4) to follow-up on local tolerability and AEs.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Yes

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.
+12 more criteria

Locations (1)

CTC (Clinical Trial Consultants) AB

Uppsala, Sweden, Sweden

Key Dates

Start Date

August 19, 2024

Primary Completion Date

March 31, 2025

Completion Date

March 31, 2025

Last Updated

January 28, 2026

Enrollment

ACTUAL participants

Conditions

Actinic Keratosis

Interventions

GZ21T

DRUG

The Effect of Topical Imipramine on Photodynamic Therapy-Mediated Immunosuppression on Forearms or Face on US Veterans

NCT06778434

Actinic KeratosisImipramine+1 more

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RECRUITING

Investigation of the Efficacy and Tolerability of Topical Applied Tirbanibulin on Actinic Keratoses With Downward-directed Proliferation Patterns

NCT06648447

Actinic Keratosis (AK)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 28, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Trial to Investigate GZ21T in Healthy Volunteers

Inclusion Criteria

Exclusion Criteria

The Effect of Topical Imipramine on Photodynamic Therapy-Mediated Immunosuppression on Forearms or Face on US Veterans

Investigation of the Efficacy and Tolerability of Topical Applied Tirbanibulin on Actinic Keratoses With Downward-directed Proliferation Patterns

The Effect of Topical Imipramine on Pain and Effectiveness of Topical Photodynamic Therapy

Indoor Daylight Photodynamic Therapy is an Effective, First-line Treatment for AK, But Its Feasibility is Limited by the Time Required for the Illumination (2 Hours). Our Objective Was to Evaluate the Efficacy of Idl-PDT With an Illumination Time of 1 Hour Versus 2 Hours in the Treatment of Scalp AK

Safety and Efficacy of Ingenol Mebutate Once Daily for 2 or 3 Consecutive Days in Subjects With Actinic Keratosis

Efficacy and Safety of Ingenol Mebutate Gel 0.06% When Applied Once Daily for 2, 3 or 4 Consecutive Days to a Treatment Area of Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis