NCT06888362

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Genzada Pharmaceuticals USA, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
DRUG	GZ21T	GZ21T cream is intended to be studied as a potential treatment for patients with actinic keratoses and other dermatologic conditions which may be amendable to the study treatment.

Timeline

• Start date: 2024-08-19
• Primary completion: 2025-03-31
• Completion: 2025-03-31
• First posted: 2025-03-21
• Last updated: 2026-01-28
• Results posted: 2026-01-28

Locations

1 site across 1 country: Sweden