Trial to Investigate GZ21T in Healthy Volunteers

NCT06888362 | Completed Phase 1 Results

• 2 other identifiers: A24-0001..2024-512893-86-00
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Actinic Keratosis

Keywords

Actinic keratosis

Outcome Measures

Primary Outcomes (7)

• AE

  Number of reported adverse events (AEs).

  Day 1 to Day 7

• Number of Reported Skin Reactions

  Local tolerability reactions, such as Erythema, swelling, pruritus, burning, blistering and urticaria, discolouration and dryness (Investigator's assessment 0-3 none/mild/moderate/severe).

  Day 1 to Day 7.

• Number of Participants With Clinically Significant Changes in Vital Signs

  Number of participants in Part A with clinically significant changes from baseline in vital signs (systolic, diastolic blood pressure and pulse)

  Day 1 to Day 7.

• Number of Participants With Clinically Significant Changes in Electrocardiograms (ECGs)

  Number of participants in Part A with clinically significant changes from baseline in ECG results (resting heart rate, PQ/PR, QRS, QT and QTcF).

  Day 1 to Day 7.

• Number of Participants With Clinically Significant Abnormal Laboratory Test Results (Haematology, Clinical Chemistry, Coagulation)

  Number of participants in Part A with clinically significant abnormal laboratory tests results (clinical chemistry, hematology and coagulation parameters).

  Day 1 to Day 7.

• Number of Participants With Clinically Significant Changes in Physical Examination Findings.

  Number of participants in Part A with clinically significant changes from baseline in physical examination findings.

  Day 1 to Day 7.

• Amount of Cream Absorbed After Single Dose Applications.

  Cream absorption measured on a 4-point scale: "1= not absorbed"; "2= somewhat absorbed"; "3= mostly absorbed"; "4= completely absorbed". This outcome was prespecified to be assessed only for Part B.

  0-2 hours after IMP administration

Secondary Outcomes (6)

• Plasma Concentrations

  Day 1 to Day 7.

• PK Parameters- AUCinf

  Day 1 to Day 7.

• PK Parameters - AUClast

  Day 1 to Day 7.

• PK Parameters - Cmax

  Day 1 to Day 7.

• PK Parameters - Tmax

  Day 1 to Day 7.

Study Arms (7)

Part A, Cohort 1

EXPERIMENTAL

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.

Drug: GZ21T

Part A, Cohort 2

EXPERIMENTAL

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.

Drug: GZ21T

Part A, Cohort 3

EXPERIMENTAL

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.

Drug: GZ21T

Part A, Cohort 4:

EXPERIMENTAL

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.

Drug: GZ21T

Part B, Cohort 1

EXPERIMENTAL

13 mg/cm2 GZ21T will be applied to 900 cm2 of the skin, corresponding to approximately 5% BSA and 11.7 g cream

Drug: GZ21T

Part B, Cohort 2

EXPERIMENTAL

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

Drug: GZ21T

Part B, Cohort 3

EXPERIMENTAL

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

Drug: GZ21T

Interventions

GZ21T DRUG

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.

Part A, Cohort 1; Part A, Cohort 2; Part A, Cohort 3; Part A, Cohort 4:; Part B, Cohort 1; Part B, Cohort 2; Part B, Cohort 3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• 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.
• Prescence of body hair or tattoos on the intended application areas, which in the opinion of the Investigator could interfere with local tolerability assessments.
• Females who are pregnant, currently breastfeeding, or intend to become pregnant during the course of the trial.
• Any positive result at the screening visit for serum hepatitis B surface antigen, hepatitis B and C antibodies and/or human immunodeficiency virus (HIV).
• 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
• Prolonged QTcF (\>450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG at the screening visit, as judged by the Investigator.
• 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.
• 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.

Sponsors & Collaborators

• Genzada Pharmaceuticals USA, Inc.: lead
• CTC Clinical Trial Consultants AB: collaborator

Study Sites (1)

CTC (Clinical Trial Consultants) AB

Uppsala, Sweden, 75237, Sweden

Location

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Cameron West, Chief Operating Officer
• Organization: Ankh Life Sciences Limited

Cameron.West@genzada.com

+1 620

Study Officials

• Cameron West

  Ankh Life Sciences Limited

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Part A: Double-blind Part B: Open-label
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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. 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.

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: March 21, 2025
• Study Start: August 19, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: January 28, 2026
• Results First Posted: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)