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CompletedNCT06888362Updated Jan 28, 2026Results posted

Trial to Investigate GZ21T in Healthy Volunteers

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

Phase
Phase 1
Study type
Interventional
Enrollment
41
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Actinic Keratosis

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Keywords

  • Actinic keratosis
03

In context

Keratosis, Actinic

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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 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.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the administration of IMP.
  3. 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.
  4. Malignancy within the past 5 years, including removal of basal cell carcinoma.
  5. Any planned major surgery within the duration of the trial.
  6. Any skin condition including tattoos that may limit the evaluation of e.g., local tolerability as judged by the Investigator.
  7. History of chronic urticaria, known history of urticaria triggered by specific factors or currently experiencing an episode of urticaria within the past 3 months.
  8. History of psoriasis, atopic eczema and similar conditions, as judged by the Investigator.
  9. Prescence of body hair or tattoos on the intended application areas, which in the opinion of the Investigator could interfere with local tolerability assessments.
  10. Females who are pregnant, currently breastfeeding, or intend to become pregnant during the course of the trial.
  11. Any positive result at the screening visit for serum hepatitis B surface antigen, hepatitis B and C antibodies and/or human immunodeficiency virus (HIV).
  12. 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
  13. Prolonged QTcF (>450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG at the screening visit, as judged by the Investigator.
  14. 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.
  15. 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.
  16. 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.
  17. 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.
  18. 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.
  19. 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.)
  20. History of alcohol abuse or excessive intake of alcohol, history or presence of drug abuse including anabolic steroids, as judged by the Investigator.
  21. 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.
  22. The Investigator considers the participant unlikely to comply with trial procedures, restrictions and requirements.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
41 participants (actual)

Study arms

  • Experimental
    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.

    Drug: GZ21T

  • Experimental
    Part A, 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.

    Drug: GZ21T

  • Experimental
    Part A, 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.

    Drug: GZ21T

  • Experimental
    Part A, 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.

    Drug: GZ21T

  • Experimental
    Part B, Cohort 1

    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

  • Experimental
    Part B, Cohort 2

    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

  • Experimental
    Part B, Cohort 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

    Drug: GZ21T

Interventions

  • DrugGZ21T

    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.

06

What researchers measure

Primary outcomes

  1. AE

    Number of reported adverse events (AEs).

    Time frame: Day 1 to Day 7

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  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

Secondary outcomes

  1. Plasma Concentrations

    Plasma concentrations of GZ21T after single dose applications.

    Time frame: Day 1 to Day 7.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

07

Results

Posted Jan 28, 2026

Participant flow

Participant flow — Overall Study
MilestonePart A, Cohort 1Part A, Cohort 2Part A, Cohort 3Part A, Cohort 4Part A: PlaceboPart B, Cohort 1Part B, Cohort 2Part B, Cohort 3
Started66668333
Completed66668333
Not completed00000000

Outcome measures

PrimaryAE

Number of reported adverse events (AEs).

Time frame:
Day 1 to Day 7
Reported as:
Number · participants
AE
participantsPart A, Cohort 1Part A, Cohort 2Part A, Cohort 3Part A, Cohort 4Part A: PlaceboPart B, Cohort 1Part B, Cohort 2Part B, Cohort 3
Any AE30233110
Any SAE00100000
Causality: not related00112100
Causality: unlikely related30122010
Causality: possibly related10000010
Causality: probably related00000000
Causality: definetly related00000000
Severity: mild30233110
Severity: moderate00100000
Severity: severe00000000
Severity: life-threatening00000000
Severity: death00000000
PrimaryNumber 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.
Reported as:
Number · participants
Number of Reported Skin Reactions
participantsPart A, Cohort 1Part A, Cohort 2Part A, Cohort 3Part A, Cohort 4Part A: PlaceboPart B, Cohort 1Part B, Cohort 2Part B, Cohort 3
Any erythema20042000
Any swelling00000000
Any pruritus00000000
Any burning00020000
Any blistering00000000
Any urticaria00000000
Any discoloration00001000
Any dryness00000100
PrimaryNumber 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.
Reported as:
Number · participants
Number of Participants With Clinically Significant Changes in Vital Signs
participantsPart A, Cohort 1Part A, Cohort 2Part A, Cohort 3Part A, Cohort 4Part A: Placebo
Systolic blood pressure00000
Diastolic blood pressure00000
Pulse00000
PrimaryNumber 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.
Reported as:
Number · participants
Number of Participants With Clinically Significant Changes in Electrocardiograms (ECGs)
participantsPart A, Cohort 1Part A, Cohort 2Part A, Cohort 3Part A, Cohort 4Part A: Placebo
Resting heart rate00000
PQ/PR00000
QRS00000
QT00000
QTcF00000
PrimaryNumber 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.
Reported as:
Number · participants
Number of Participants With Clinically Significant Abnormal Laboratory Test Results (Haematology, Clinical Chemistry, Coagulation)
participantsPart A, Cohort 1Part A, Cohort 2Part A, Cohort 3Part A, Cohort 4Part A: Placebo
Haematology00000
Clinical chemistry00000
Coagulation00000
PrimaryNumber 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.
Reported as:
Number · participants
Number of Participants With Clinically Significant Changes in Physical Examination Findings.
participantsPart A, Cohort 1Part A, Cohort 2Part A, Cohort 3Part A, Cohort 4Part A: Placebo
Number of Participants With Clinically Significant Changes in Physical Examination Findings.10000
PrimaryAmount 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
Reported as:
Number · participants
Amount of Cream Absorbed After Single Dose Applications.
participantsPart B, Cohort 1Part B, Cohort 2Part B, Cohort 3
30 min post-dose. Score 1 - not absorbed000
30 min postdose. Score 2 - somewhat absorbed332
30 min postdose. Score 3 - mostly absorbed001
30 min postdose. Score 4 - completely absorbed000
1 hour post-dose. Score 1 - not absorbed000
1 hour postdose. Score 2 - somewhat absorbed330
1 hour postdose. Score 3 - mostly absorbed003
1 hour postdose. Score 4 - completely absorbed000
2 hours post-dose. Score 1 - not absorbed000
2 hours postdose. Score 2 - somewhat absorbed330
2 hours postdose. Score 3 - mostly absorbed003
2 hours postdose. Score 4 - completely absorbed000
SecondaryPlasma Concentrations

Plasma concentrations of GZ21T after single dose applications.

Time frame:
Day 1 to Day 7.

Results for this outcome have not been posted.

SecondaryPK 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.

Results for this outcome have not been posted.

SecondaryPK 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.

Results for this outcome have not been posted.

SecondaryPK 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.

Results for this outcome have not been posted.

SecondaryPK 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.

Results for this outcome have not been posted.

SecondaryPK 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.

Results for this outcome have not been posted.

Adverse events

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.

Adverse event summary by group
GroupDeathsSeriousOther
Part A, Cohort 10/6 (0%)0/6 (0%)3/6 (50%)
Part A, Cohort 20/6 (0%)0/6 (0%)0/6 (0%)
Part A, Cohort 30/6 (0%)1/6 (16.7%)2/6 (33.3%)
Part A, Cohort 40/6 (0%)0/6 (0%)3/6 (50%)
Part A: Placebo0/8 (0%)0/8 (0%)3/8 (37.5%)
Part B, Cohort 10/3 (0%)0/3 (0%)1/3 (33.3%)
Part B, Cohort 20/3 (0%)0/3 (0%)1/3 (33.3%)
Part B, Cohort 30/3 (0%)0/3 (0%)0/3 (0%)
Most frequent serious events
Most frequent serious events
EventPart A, Cohort 1Part A, Cohort 2Part A, Cohort 3Part A, Cohort 4Part A: PlaceboPart B, Cohort 1Part B, Cohort 2Part B, Cohort 3
Catheter site thrombosisGeneral disorders0/60/61/60/60/80/30/30/3
Most frequent other events
Showing 10 of 13
Most frequent other events
EventPart A, Cohort 1Part A, Cohort 2Part A, Cohort 3Part A, Cohort 4Part A: PlaceboPart B, Cohort 1Part B, Cohort 2Part B, Cohort 3
ErythemaSkin and subcutaneous tissue disorders2/60/60/60/61/80/30/30/3
PruritusSkin and subcutaneous tissue disorders2/60/60/60/60/80/30/30/3
Application site warmthGeneral disorders0/60/60/60/60/80/31/30/3
Back painMusculoskeletal and connective tissue disorders0/60/60/60/60/81/30/30/3
CoughRespiratory, thoracic and mediastinal disorders0/60/60/60/60/80/31/30/3
HeadacheNervous system disorders0/60/60/61/62/80/30/30/3
MigraineNervous system disorders0/60/61/60/60/80/30/30/3
Application site pruritusGeneral disorders1/60/60/60/60/80/30/30/3
Abdominal painGastrointestinal disorders0/60/60/61/60/80/30/30/3
StomatitisGastrointestinal disorders1/60/60/60/60/80/30/30/3

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Part A, Cohort 1Part A, Cohort 2Part A, Cohort 3Part A, Cohort 4Part A: PlaceboPart B, Cohort 1Part B, Cohort 2Part B, Cohort 3Total
<=18 years000000000
Between 18 and 65 years5356823335
>=65 years131001006
Age, Continuous
Age, Continuous(years)Part A, Cohort 1Part A, Cohort 2Part A, Cohort 3Part A, Cohort 4Part A: PlaceboPart B, Cohort 1Part B, Cohort 2Part B, Cohort 3Total
Mean35.5 ± 16.662.2 ± 5.847.0 ± 21.639.7 ± 9.939.5 ± 17.825.0 ± 2.620.3 ± 1.237.3 ± 27.540.7 ± 17.0
Sex: Female, Male
Sex: Female, Male(Participants)Part A, Cohort 1Part A, Cohort 2Part A, Cohort 3Part A, Cohort 4Part A: PlaceboPart B, Cohort 1Part B, Cohort 2Part B, Cohort 3Total
Female3336633330
Male3330200011
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Part A, Cohort 1Part A, Cohort 2Part A, Cohort 3Part A, Cohort 4Part A: PlaceboPart B, Cohort 1Part B, Cohort 2Part B, Cohort 3Total
Hispanic or Latino000000101
Not Hispanic or Latino6666832340
Unknown or Not Reported000000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Part A, Cohort 1Part A, Cohort 2Part A, Cohort 3Part A, Cohort 4Part A: PlaceboPart B, Cohort 1Part B, Cohort 2Part B, Cohort 3Total
American Indian or Alaska Native000000000
Asian000000000
Native Hawaiian or Other Pacific Islander000000000
Black or African American000000000
White6666833341
More than one race000000000
Unknown or Not Reported000000000
Region of Enrollment
Region of Enrollment(participants)Part A, Cohort 1Part A, Cohort 2Part A, Cohort 3Part A, Cohort 4Part A: PlaceboPart B, Cohort 1Part B, Cohort 2Part B, Cohort 3Total
Sweden6666833341
08

Study locations

1 site
  • CTC (Clinical Trial Consultants) AB
    Uppsala, Sweden 75237, Sweden
09

References and documents

Study documents

  • Study protocol · Nov 20, 2024
  • Statistical analysis plan · Apr 28, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06888362
Lead sponsor
Genzada Pharmaceuticals USA, Inc.
Collaborators
CTC Clinical Trial Consultants AB
Responsible party
Sponsor
First posted
Mar 21, 2025
Start date
Aug 19, 2024
Primary completion
Mar 31, 2025
Completion
Mar 31, 2025
Results posted
Jan 28, 2026
Last update
Jan 28, 2026

Study contacts

Cameron West
study director · Ankh Life Sciences Limited

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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