Actinic KeratosisPhase 1NCT06888362
Trial to Investigate GZ21T in Healthy Volunteers
A Phase 1 study testing GZ21T in people with Actinic Keratosis, run by Genzada Pharmaceuticals USA, Inc. at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- GZ21T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSweden
- Study dates
- 19 Aug 2024to 31 Mar 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 22Show fewer
- 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.
- Unwillingness to abstain from the use of topical treatment (including but not limited to corticosteroids, calcineurin inhibitors, vitamin D analogues, and retinoids) at the application site within 1 week prior to Day 1 and from the use of moisturising ointment cream, emollients, oils (including shower oil) or sunscreen within 24 hours prior to Day 1 until 1 week after IMP administration.
- Planned treatment or treatment with another investigational drug within 3 months prior to Day 1. Participants who consented and screened but were not dosed in previous clinical trials are not to be excluded.
- Current smokers or users of nicotine products. Irregular use of nicotine (e.g., smoking, snuffing, chewing tobacco) less than 3 times per week is allowed before screening visit.
- Positive screening result for drugs of abuse or alcohol at the screening visit or on admission to the trial site prior to the administration of the IMP. (Positive results that are expected given the participant's medical history and prescribed medications can be disregarded as judged by the Investigator.)
- History of alcohol abuse or excessive intake of alcohol, history or presence of drug abuse including anabolic steroids, as judged by the Investigator.
- Plasma donation within approximately 1 month of screening or blood donation (or corresponding blood loss) during the last 3 months prior to screening, at the discretion of the Investigator.
- The Investigator considers the participant unlikely to comply with trial procedures, restrictions and requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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
- Being tested
- GZ21T
- Keywords
- Actinic keratosis
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GZ21TDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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 Receives: 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 Receives: 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 Receives: Drug: GZ21T |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE
Number of reported adverse events (AEs).
Measured: 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).
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 0-2 hours after IMP administration
Secondary outcomes (6)
Plasma Concentrations
Plasma concentrations of GZ21T after single dose applications.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Day 1 to Day 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start19 Aug 2024
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzada Pharmaceuticals USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CTC Clinical Trial Consultants AB
- Responsible party
- Sponsor
- Investigators
- Cameron West, Study director, Ankh Life Sciences Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888362
- Sponsor's protocol ID
- A24-0001..
- Other IDs
- 2024-512893-86-00
- Status last verified
- Jan 2026
- First submitted
- 15 Jul 2024
- Last updated
- 28 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06888362
- Acronym / sponsor ID
- A24-0001..
- Conditions
- Actinic Keratosis
- Keywords
- Actinic keratosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Genzada Pharmaceuticals USA, Inc.Industry (pharma, biotech, devices)
- Collaborators
- CTC Clinical Trial Consultants AB
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 21 Mar 2025 (actual)
- Results
- Posted 28 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 7
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Part A, Cohort 1 | Experimental | Drug: GZ21T25.5 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 | Drug: GZ21T25.5 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 | Drug: GZ21T25.5 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 | Drug: GZ21T25.5 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 | Drug: GZ21T13 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 | Drug: GZ21TA 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 | Drug: GZ21TA 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GZ21TGZ21T 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. | Drug | 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 |
Primary outcome
AE
Time frame: Day 1 to Day 7
Number of reported adverse events (AEs).
Number of Reported Skin Reactions
Time frame: Day 1 to Day 7.
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 With Clinically Significant Changes in Vital Signs
Time frame: Day 1 to Day 7.
Number of participants in Part A with clinically significant changes from baseline in vital signs (systolic, diastolic blood pressure and pulse)
Number of Participants With Clinically Significant Changes in Electrocardiograms (ECGs)
Time frame: Day 1 to Day 7.
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 With Clinically Significant Abnormal Laboratory Test Results (Haematology, Clinical Chemistry, Coagulation)
Time frame: Day 1 to Day 7.
Number of participants in Part A with clinically significant abnormal laboratory tests results (clinical chemistry, hematology and coagulation parameters).
Number of Participants With Clinically Significant Changes in Physical Examination Findings.
Time frame: Day 1 to Day 7.
Number of participants in Part A with clinically significant changes from baseline in physical examination findings.
Amount of Cream Absorbed After Single Dose Applications.
Time frame: 0-2 hours after IMP administration
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.
6 secondary outcomes
Plasma Concentrations
Time frame: Day 1 to Day 7.
PK Parameters- AUCinf
Time frame: Day 1 to Day 7.
PK Parameters - AUClast
Time frame: Day 1 to Day 7.
PK Parameters - Cmax
Time frame: Day 1 to Day 7.
PK Parameters - Tmax
Time frame: Day 1 to Day 7.
PK Parameters - T½
Time frame: Day 1 to Day 7.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Actinic Keratosis
Active, not recruitingPhase 1
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725
Netherton Syndrome
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
Actinic Keratosis
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
Actinic Keratosis
Active, not recruitingPhase 3
A Pilot Clinical Trial Comparing Topical Fluorouracil to Fluorouracil Plus Calcipotriene Field Treatments in Patients With Multiple Actinic Keratoses
Multiple Actinic Keratoses
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cameron West study director
Ankh Life Sciences Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GZ21T in people with Actinic Keratosis, run by Genzada Pharmaceuticals USA, Inc. at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AE (time frame: Day 1 to Day 7). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.