Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GZ21T · 1 trial · 1 indication
Number of reported adverse events (AEs).
Local tolerability reactions, such as Erythema, swelling, pruritus, burning, blistering and urticaria, discolouration and dryness (Investigator's assessment 0-3 none/mild/moderate/severe).
Number of participants in Part A with clinically significant changes from baseline in vital signs (systolic, diastolic blood pressure and pulse)
Number of participants in Part A with clinically significant changes from baseline in ECG results (resting heart rate, PQ/PR, QRS, QT and QTcF).
Number of participants in Part A with clinically significant abnormal laboratory tests results (clinical chemistry, hematology and coagulation parameters).
Number of participants in Part A with clinically significant changes from baseline in physical examination findings.
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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 |
| 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 |
| 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 |
| Name | Type | Description |
|---|---|---|
| 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. |
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 ...