A Phase 1 interventional study of GZ21T in Actinic Keratosis, sponsored by Genzada Pharmaceuticals USA, Inc.. Completed at 1 site in Sweden. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-28.
Sponsored by Genzada Pharmaceuticals USA, Inc. · Phase 1, Interventional, and Treatment
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.
Participants will receive a single topical application of GZ21T or placebo:
Part A:
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:
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.
364 studies on the registry are indexed under Keratosis, Actinic; 31 are open to participants now.
This study's enrollment of 41 is below the median of 60 across 315 interventional studies indexed under Keratosis, Actinic.
Browse Keratosis, Actinic studies →Genzada Pharmaceuticals USA, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
WOCBP must refrain from donating eggs from the first IMP administration until 3 months after the last IMP administration.
Exclusion Criteria:
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
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
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
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
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
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
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
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.
AE
Number of reported adverse events (AEs).
Time frame: 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).
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 0-2 hours after IMP administration
Plasma Concentrations
Plasma concentrations of GZ21T after single dose applications.
Time frame: Day 1 to Day 7.
PK Parameters- AUCinf
PK parameters after a single dose application (to be calculated if data permits): area under the plasma concentration curve from time 0 to infinity (AUCinf).
Time frame: Day 1 to Day 7.
PK Parameters - AUClast
PK parameters after a single dose application (to be calculated if data permits): AUC from time 0 to the last measurable concentration (AUClast).
Time frame: Day 1 to Day 7.
PK Parameters - Cmax
PK parameters after a single dose application (to be calculated if data permits): maximum plasma concentration (Cmax).
Time frame: Day 1 to Day 7.
PK Parameters - Tmax
PK parameters after a single dose application (to be calculated if data permits): time to Cmax (Tmax).
Time frame: Day 1 to Day 7.
PK Parameters - T½
PK parameters after a single dose application (to be calculated if data permits): terminal elimination half-life (T½).
Time frame: Day 1 to Day 7.
| Milestone | Part A, Cohort 1 | Part A, Cohort 2 | Part A, Cohort 3 | Part A, Cohort 4 | Part A: Placebo | Part B, Cohort 1 | Part B, Cohort 2 | Part B, Cohort 3 |
|---|---|---|---|---|---|---|---|---|
| Started | 6 | 6 | 6 | 6 | 8 | 3 | 3 | 3 |
| Completed | 6 | 6 | 6 | 6 | 8 | 3 | 3 | 3 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Number of reported adverse events (AEs).
| participants | Part A, Cohort 1 | Part A, Cohort 2 | Part A, Cohort 3 | Part A, Cohort 4 | Part A: Placebo | Part B, Cohort 1 | Part B, Cohort 2 | Part B, Cohort 3 |
|---|---|---|---|---|---|---|---|---|
| Any AE | 3 | 0 | 2 | 3 | 3 | 1 | 1 | 0 |
| Any SAE | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Causality: not related | 0 | 0 | 1 | 1 | 2 | 1 | 0 | 0 |
| Causality: unlikely related | 3 | 0 | 1 | 2 | 2 | 0 | 1 | 0 |
| Causality: possibly related | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Causality: probably related | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Causality: definetly related | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Severity: mild | 3 | 0 | 2 | 3 | 3 | 1 | 1 | 0 |
| Severity: moderate | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Severity: severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Severity: life-threatening | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Severity: death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Local tolerability reactions, such as Erythema, swelling, pruritus, burning, blistering and urticaria, discolouration and dryness (Investigator's assessment 0-3 none/mild/moderate/severe).
| participants | Part A, Cohort 1 | Part A, Cohort 2 | Part A, Cohort 3 | Part A, Cohort 4 | Part A: Placebo | Part B, Cohort 1 | Part B, Cohort 2 | Part B, Cohort 3 |
|---|---|---|---|---|---|---|---|---|
| Any erythema | 2 | 0 | 0 | 4 | 2 | 0 | 0 | 0 |
| Any swelling | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Any pruritus | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Any burning | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 |
| Any blistering | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Any urticaria | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Any discoloration | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Any dryness | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Number of participants in Part A with clinically significant changes from baseline in vital signs (systolic, diastolic blood pressure and pulse)
| participants | Part A, Cohort 1 | Part A, Cohort 2 | Part A, Cohort 3 | Part A, Cohort 4 | Part A: Placebo |
|---|---|---|---|---|---|
| Systolic blood pressure | 0 | 0 | 0 | 0 | 0 |
| Diastolic blood pressure | 0 | 0 | 0 | 0 | 0 |
| Pulse | 0 | 0 | 0 | 0 | 0 |
Number of participants in Part A with clinically significant changes from baseline in ECG results (resting heart rate, PQ/PR, QRS, QT and QTcF).
| participants | Part A, Cohort 1 | Part A, Cohort 2 | Part A, Cohort 3 | Part A, Cohort 4 | Part A: Placebo |
|---|---|---|---|---|---|
| Resting heart rate | 0 | 0 | 0 | 0 | 0 |
| PQ/PR | 0 | 0 | 0 | 0 | 0 |
| QRS | 0 | 0 | 0 | 0 | 0 |
| QT | 0 | 0 | 0 | 0 | 0 |
| QTcF | 0 | 0 | 0 | 0 | 0 |
Number of participants in Part A with clinically significant abnormal laboratory tests results (clinical chemistry, hematology and coagulation parameters).
| participants | Part A, Cohort 1 | Part A, Cohort 2 | Part A, Cohort 3 | Part A, Cohort 4 | Part A: Placebo |
|---|---|---|---|---|---|
| Haematology | 0 | 0 | 0 | 0 | 0 |
| Clinical chemistry | 0 | 0 | 0 | 0 | 0 |
| Coagulation | 0 | 0 | 0 | 0 | 0 |
Number of participants in Part A with clinically significant changes from baseline in physical examination findings.
| participants | Part A, Cohort 1 | Part A, Cohort 2 | Part A, Cohort 3 | Part A, Cohort 4 | Part A: Placebo |
|---|---|---|---|---|---|
| Number of Participants With Clinically Significant Changes in Physical Examination Findings. | 1 | 0 | 0 | 0 | 0 |
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.
| participants | Part B, Cohort 1 | Part B, Cohort 2 | Part B, Cohort 3 |
|---|---|---|---|
| 30 min post-dose. Score 1 - not absorbed | 0 | 0 | 0 |
| 30 min postdose. Score 2 - somewhat absorbed | 3 | 3 | 2 |
| 30 min postdose. Score 3 - mostly absorbed | 0 | 0 | 1 |
| 30 min postdose. Score 4 - completely absorbed | 0 | 0 | 0 |
| 1 hour post-dose. Score 1 - not absorbed | 0 | 0 | 0 |
| 1 hour postdose. Score 2 - somewhat absorbed | 3 | 3 | 0 |
| 1 hour postdose. Score 3 - mostly absorbed | 0 | 0 | 3 |
| 1 hour postdose. Score 4 - completely absorbed | 0 | 0 | 0 |
| 2 hours post-dose. Score 1 - not absorbed | 0 | 0 | 0 |
| 2 hours postdose. Score 2 - somewhat absorbed | 3 | 3 | 0 |
| 2 hours postdose. Score 3 - mostly absorbed | 0 | 0 | 3 |
| 2 hours postdose. Score 4 - completely absorbed | 0 | 0 | 0 |
Plasma concentrations of GZ21T after single dose applications.
Results for this outcome have not been posted.
PK parameters after a single dose application (to be calculated if data permits): area under the plasma concentration curve from time 0 to infinity (AUCinf).
Results for this outcome have not been posted.
PK parameters after a single dose application (to be calculated if data permits): AUC from time 0 to the last measurable concentration (AUClast).
Results for this outcome have not been posted.
PK parameters after a single dose application (to be calculated if data permits): maximum plasma concentration (Cmax).
Results for this outcome have not been posted.
PK parameters after a single dose application (to be calculated if data permits): time to Cmax (Tmax).
Results for this outcome have not been posted.
PK parameters after a single dose application (to be calculated if data permits): terminal elimination half-life (T½).
Results for this outcome have not been posted.
Collected over AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part A, Cohort 1 | 0/6 (0%) | 0/6 (0%) | 3/6 (50%) |
| Part A, Cohort 2 | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Part A, Cohort 3 | 0/6 (0%) | 1/6 (16.7%) | 2/6 (33.3%) |
| Part A, Cohort 4 | 0/6 (0%) | 0/6 (0%) | 3/6 (50%) |
| Part A: Placebo | 0/8 (0%) | 0/8 (0%) | 3/8 (37.5%) |
| Part B, Cohort 1 | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) |
| Part B, Cohort 2 | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) |
| Part B, Cohort 3 | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Event | Part A, Cohort 1 | Part A, Cohort 2 | Part A, Cohort 3 | Part A, Cohort 4 | Part A: Placebo | Part B, Cohort 1 | Part B, Cohort 2 | Part B, Cohort 3 |
|---|---|---|---|---|---|---|---|---|
| Catheter site thrombosisGeneral disorders | 0/6 | 0/6 | 1/6 | 0/6 | 0/8 | 0/3 | 0/3 | 0/3 |
| Event | Part A, Cohort 1 | Part A, Cohort 2 | Part A, Cohort 3 | Part A, Cohort 4 | Part A: Placebo | Part B, Cohort 1 | Part B, Cohort 2 | Part B, Cohort 3 |
|---|---|---|---|---|---|---|---|---|
| ErythemaSkin and subcutaneous tissue disorders | 2/6 | 0/6 | 0/6 | 0/6 | 1/8 | 0/3 | 0/3 | 0/3 |
| PruritusSkin and subcutaneous tissue disorders | 2/6 | 0/6 | 0/6 | 0/6 | 0/8 | 0/3 | 0/3 | 0/3 |
| Application site warmthGeneral disorders | 0/6 | 0/6 | 0/6 | 0/6 | 0/8 | 0/3 | 1/3 | 0/3 |
| Back painMusculoskeletal and connective tissue disorders | 0/6 | 0/6 | 0/6 | 0/6 | 0/8 | 1/3 | 0/3 | 0/3 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/6 | 0/6 | 0/6 | 0/6 | 0/8 | 0/3 | 1/3 | 0/3 |
| HeadacheNervous system disorders | 0/6 | 0/6 | 0/6 | 1/6 | 2/8 | 0/3 | 0/3 | 0/3 |
| MigraineNervous system disorders | 0/6 | 0/6 | 1/6 | 0/6 | 0/8 | 0/3 | 0/3 | 0/3 |
| Application site pruritusGeneral disorders | 1/6 | 0/6 | 0/6 | 0/6 | 0/8 | 0/3 | 0/3 | 0/3 |
| Abdominal painGastrointestinal disorders | 0/6 | 0/6 | 0/6 | 1/6 | 0/8 | 0/3 | 0/3 | 0/3 |
| StomatitisGastrointestinal disorders | 1/6 | 0/6 | 0/6 | 0/6 | 0/8 | 0/3 | 0/3 | 0/3 |
| Age, Categorical(Participants) | Part A, Cohort 1 | Part A, Cohort 2 | Part A, Cohort 3 | Part A, Cohort 4 | Part A: Placebo | Part B, Cohort 1 | Part B, Cohort 2 | Part B, Cohort 3 | Total |
|---|---|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 3 | 5 | 6 | 8 | 2 | 3 | 3 | 35 |
| >=65 years | 1 | 3 | 1 | 0 | 0 | 1 | 0 | 0 | 6 |
| Age, Continuous(years) | Part A, Cohort 1 | Part A, Cohort 2 | Part A, Cohort 3 | Part A, Cohort 4 | Part A: Placebo | Part B, Cohort 1 | Part B, Cohort 2 | Part B, Cohort 3 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 35.5 ± 16.6 | 62.2 ± 5.8 | 47.0 ± 21.6 | 39.7 ± 9.9 | 39.5 ± 17.8 | 25.0 ± 2.6 | 20.3 ± 1.2 | 37.3 ± 27.5 | 40.7 ± 17.0 |
| Sex: Female, Male(Participants) | Part A, Cohort 1 | Part A, Cohort 2 | Part A, Cohort 3 | Part A, Cohort 4 | Part A: Placebo | Part B, Cohort 1 | Part B, Cohort 2 | Part B, Cohort 3 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female | 3 | 3 | 3 | 6 | 6 | 3 | 3 | 3 | 30 |
| Male | 3 | 3 | 3 | 0 | 2 | 0 | 0 | 0 | 11 |
| Ethnicity (NIH/OMB)(Participants) | Part A, Cohort 1 | Part A, Cohort 2 | Part A, Cohort 3 | Part A, Cohort 4 | Part A: Placebo | Part B, Cohort 1 | Part B, Cohort 2 | Part B, Cohort 3 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Not Hispanic or Latino | 6 | 6 | 6 | 6 | 8 | 3 | 2 | 3 | 40 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Part A, Cohort 1 | Part A, Cohort 2 | Part A, Cohort 3 | Part A, Cohort 4 | Part A: Placebo | Part B, Cohort 1 | Part B, Cohort 2 | Part B, Cohort 3 | Total |
|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| White | 6 | 6 | 6 | 6 | 8 | 3 | 3 | 3 | 41 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Part A, Cohort 1 | Part A, Cohort 2 | Part A, Cohort 3 | Part A, Cohort 4 | Part A: Placebo | Part B, Cohort 1 | Part B, Cohort 2 | Part B, Cohort 3 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sweden | 6 | 6 | 6 | 6 | 8 | 3 | 3 | 3 | 41 |
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Genzada Pharmaceuticals USA, Inc.