Trial to Investigate GZ21T in Healthy Volunteers

Last updated: March 14, 2025
Sponsor: Genzada Pharmaceuticals USA, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Warts

Squamous Cell Carcinoma

Sun Poisoning

Treatment

GZ21T

Clinical Study ID

NCT06888362
A24-0001..
2024-512893-86-00
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

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 thisis the preferred and usual lifestyle of the participant) or must agree to use ahighly effective method of contraception with a failure rate of <1 % to preventpregnancy from at least 2 weeks prior to the administration of IMP to 4 weeks afterthe last administration of IMP. In addition, any male partner of a femaleparticipant must, unless he is sterile (e.g., has undergone vasectomy), agree to usea condom from the first administration of IMP until 4 weeks after the lastadministration of IMP.

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

Exclusion

Exclusion Criteria:

  1. History of any clinically significant disease or disorder which, in the opinion ofthe Investigator, may either put the participant at risk because of participation inthe trial or influence the results or the participant's ability to participate inthe trial.

  2. Any clinically significant illness, medical/surgical procedure, or trauma within 4weeks of the administration of IMP.

  3. Any clinically significant abnormalities regarding physical examination, vitalsigns, 12- lead ECG, and laboratory values at the time of the screening visit, asjudged 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., localtolerability as judged by the Investigator.

  7. History of chronic urticaria, known history of urticaria triggered by specificfactors or currently experiencing an episode of urticaria within the past 3 months.

  8. History of psoriasis, atopic eczema and similar conditions, as judged by theInvestigator.

  9. Prescence of body hair or tattoos on the intended application areas, which in theopinion of the Investigator could interfere with local tolerability assessments.

  10. Females who are pregnant, currently breastfeeding, or intend to become pregnantduring 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 valuesoutside 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 significantabnormalities in the resting ECG at the screening visit, as judged by theInvestigator.

  14. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, asjudged by the Investigator, or history of hypersensitivity to drugs or food with asimilar 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 ofIMP, except occasional intake of paracetamol (maximum 2000 mg/day and not exceeding 3000 mg/week), as well as nasal decongestants without cortisone, antihistamine, oranticholinergics for a maximum of 10 days, at the discretion of the Investigator.

  16. Unwillingness to abstain from the use of topical treatment (including but notlimited to corticosteroids, calcineurin inhibitors, vitamin D analogues, andretinoids) at the application site within 1 week prior to Day 1 and from the use ofmoisturising ointment cream, emollients, oils (including shower oil) or sunscreenwithin 24 hours prior to Day 1 until 1 week after IMP administration.

  17. Planned treatment or treatment with another investigational drug within 3 monthsprior to Day 1. Participants who consented and screened but were not dosed inprevious 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 beforescreening visit.

  19. Positive screening result for drugs of abuse or alcohol at the screening visit or onadmission to the trial site prior to the administration of the IMP. (Positiveresults that are expected given the participant's medical history and prescribedmedications can be disregarded as judged by the Investigator.)

  20. History of alcohol abuse or excessive intake of alcohol, history or presence of drugabuse including anabolic steroids, as judged by the Investigator.

  21. Plasma donation within approximately 1 month of screening or blood donation (orcorresponding blood loss) during the last 3 months prior to screening, at thediscretion of the Investigator.

  22. The Investigator considers the participant unlikely to comply with trial procedures,restrictions and requirements.

Study Design

Total Participants: 41
Treatment Group(s): 1
Primary Treatment: GZ21T
Phase: 1
Study Start date:
August 19, 2024
Estimated Completion Date:
March 31, 2025

Study 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.

Connect with a study center

  • CTC (Clinical Trial Consultants) AB

    Uppsala, 75237
    Sweden

    Active - Recruiting

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