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HealthyPhase 1NCT06780124

Сlinical Study Aiming to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of ZE63-0302 in Healthy Volunteers

A Phase 1 study of Healthy, run by Eilean Therapeutics at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A first-in-human study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of ZE63-0302 administered orally in healthy volunteers. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
82 participants
Where
1 siteAustralia
Study dates
12 Apr 2024to 7 Nov 2025
Phase
Phase 1
Are there results?
None posted in the registry

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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
  • Adult males and females, 18 to 55 years of age (inclusive) at screening.
  • Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2, with a body weight (to 1 decimal place) ≥ 50.0 kg at screening, to be included in the main group for all SAD and MAD cohorts. BMI ≥ 30.0 and ≤ 35.0 kg/m2, with a body weight (to 1 decimal place) ≥ 50.0 kg at screening, to be included in the high BMI group for SAD Cohorts 5 and 7.
  • Medically healthy without clinically significant abnormalities (in the opinion of the Investigator) at the screening visit and prior to dosing at the timepoints indicated in the SoA, including:
  • Physical examination without any clinically significant findings.
  • Systolic blood pressure in the range of 90 mm Hg to 140 mm Hg; diastolic blood pressure in the range of 40 mm Hg to 90 mm Hg.
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  • HR in the range of 40 to 100 bpm after at least 5 minutes in a supine position
  • Body temperature (tympanic or oral) in the range 35.5°C to 37.5°C (inclusive).
  • No clinically significant findings in serum chemistry, hematology, coagulation and urinalysis tests as judged by the Investigator. Note: for SAD Cohort 6, ALT, AST, ALP and gamma-glutamyl transferase (GGT) must be normal (within the reference range).
  • Triplicate 12-lead ECG (taken after the volunteer has been supine for at least 5 minutes) with a QTcF ≤ 450 msec for males and ≤ 470 msec for females and no clinically significant abnormalities.
  • Be nonsmokers (including tobacco, nicotine replacement therapy, e-cigarettes and marijuana) for at least 3 months prior to first study drug administration (self-reported to the Investigator) at screening visit, Day -4 (SAD Cohort 6 only) and at check-in on Day -1.
  • Female volunteers must:
  • Be of nonchildbearing potential i.e., surgically sterilized (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before screening) or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause, and a follicle-stimulating hormone (FSH) level >40 IU/L at the screening visit), or
  • If of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use an acceptable method of contraception from one month prior to screening until at least 30 days after the last dose of study drug.
  • Male volunteers must agree not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use an acceptable method of contraception from signing the consent form until at least 90 days after the last dose of study drug.
  • Have suitable venous access for blood sampling.
  • Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.

Who cannot join

  • History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or major surgery within the past 3 months determined by the PI to be clinically significant.
  • Acute infections or infestations within 4 weeks prior to dosing or current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications.
  • Presence or history of any abnormality or illness, including gastrointestinal surgery, which in the opinion of the PI may affect absorption, distribution, metabolism or elimination of the study drug.
  • Any history of malignant disease in the last 5 years (excludes surgically resected skin squamous cell or basal cell carcinoma).
  • Any screening laboratory result outside the normal laboratory reference range (as confirmed upon repeated testing) and deemed clinically significant by the PI.
  • Participants who have Gilbert's syndrome, or who have hyperbilirubinemia consistent with Gilbert's syndrome, will not be eligible.
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  • Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia.
  • Use of or plans to use systemic immunosuppressive (e.g., corticosteroids by any route, methotrexate, azathioprine, cyclosporine) or immunomodulating medications (e.g., interferon) within 5 half-lives of individual agent or within 28 days (whichever is longer) prior to dosing or during the study.
  • Use of or plans to use agents (e.g., grapefruit and grapefruit products) that have clinically significant interaction with CYP3A4 or the use of any medications that could have a significantly impact on organ function (e.g., barbiturates, omeprazole, cimetidine) during the study or within 5 half-lives of individual agent or within 28 days (whichever is longer) prior to dosing.
  • History of risk factors for torsade de pointes (including a family history of long QT syndrome or sudden cardiac death) or clinically significant arrythmia.
  • Participant is planning to have surgery between Screening and the EoS visit.
  • Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies at the screening visit.
  • Presence or having sequelae of gastrointestinal, liver, kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
  • Estimated creatinine clearance < 60 mL/min using the Cockcroft-Gault formula.
  • History of any drug or alcohol abuse in the past 2 years defined as >21 units of alcohol per week for males and >14 units of alcohol per week for females. Where 1 unit = 360 mL of beer, 150 mL wine, or 30 mL of spirits.
  • No alcohol consumption within 24 hours prior to Day -4 (SAD Cohort 6 only), and/or check-in (Day -1).
  • Positive drugs of abuse, cotinine or alcohol breath test results at the screening visit, Day -4 (SAD Cohort 6 only) or at check-in (Day -1).
  • Use of any prescription medications within 14 days or at least 5 half-lives of the medication (whichever is longer) prior to the first study drug administration, including oral contraceptives and use of any over-the-counter medication (including herbal products, nutritional, diet aids, vitamin supplements, minerals and hormone supplements) within 7 days or at least 5 half-lives of the medication (whichever is longer) prior to the first study drug administration, with the exception of the occasional use of paracetamol (doses of 500 mg up to every 6 hours or 2 g per day maximum for no more than 3 consecutive days).
  • Demonstrated clinically significant (required intervention, e.g., emergency room visit, epinephrine administration) allergic reactions (e.g., food, drug, or atopic reactions, asthmatic episodes) which, in the opinion of the Investigator, would interfere with thevolunteer's ability to participate in the trial
  • Known hypersensitivity to any of the study drug ingredients.
  • Use of any inactivated vaccinations within 14 days, or any live vaccinations within 30 days prior to the first study drug administration. Note: Subjects vaccinated for COVID-19 or influenza within at least 2 weeks prior to enrollment or earlier will be considered eligible for enrollment as long as they do not present with post-vaccination clinical symptoms, have a negative rapid antigen test (in the case of COVID-19), and are deemed otherwise healthy.
  • For women of childbearing potential, a positive serum pregnancy test at the screening visit or a positive urine pregnancy test (with confirmatory serum pregnancy test) at check-in (Day -1).
  • Females who are breastfeeding or planning to breast feed at any time during the study.
  • Donation of blood or plasma within 30 days prior to first study drug administration, or loss of whole blood of more than 500 mL within 30 days prior to first study drug administration, or receipt of a blood transfusion within 1 year of first study drug administration.
  • Receiving an investigational drug in another clinical trial within 60 days or 5 half-lives of the investigational agent (whichever is longer) prior to the first study drug administration.
  • Any other condition or prior therapy that in the opinion of the Investigators would make the volunteer unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.
  • Any history of long COVID infection (defined by continuation or development of new symptoms 3 months after the initial SARS-CoV-2 infection, with these symptoms lasting for at least 2 months with no other explanation).
  • Additional exclusion criteria for SAD Cohort 6 only:
  • History or presence of clinically significant hypersensitivity or idiosyncratic reaction to itraconazole or other azole compounds, or any inactive ingredients.
  • History or presence of clinically significant liver disease.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Linear Clinical Research Ltd

    Perth, Nedlands, WA6009

Other trials in Australia

About this study

Official title: An Exploratory Randomized, Double-Blind, Placebo-Controlled, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of ZE63-0302 in Healthy Volunteers

A first-in-human study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of ZE63-0302 administered orally in healthy volunteers.

Read the detailed description

This is an exploratory Phase I, single- and multiple-dose escalation clinical trial conducted in healthy volunteers. The safety, tolerability, pharmacokinetics and pharmacodynamics of ZE63-0302 following oral administration in healthy volunteers will be evaluated using a randomized, double-blind, placebo-controlled trial design.

This study will be subdivided into two parts: a single ascending dose (SAD) part and a multiple ascending dose (MAD) part.

Healthy volunteers (BMI ≥ 18.5 and ≤ 32.0 kg/m2) and healthy volunteers with a high BMI (≥ 30.0 and ≤ 35.0 kg/m2) will be enrolled to receive single ascending doses (SAD) of ZE63-0302 or placebo under fasted or fed conditions, depending on the cohort, and healthy volunteers (BMI ≥ 18.5 and ≤ 32.0 kg/m2) will receive multiple ascending doses (MAD) of ZE63-0302 or placebo under fasted or fed conditions, depending on the cohort. The starting dose will be 20 mg with up to 7 SAD and 4 MAD cohorts planned. Sentinel dosing will be utilized in SAD Cohorts 1 to 4.

Conditions
Healthy
Being tested
ZE63-0302 or placebo
Keywords
Acute leukemia, Acute KMTRAR mutated myeloid leukemia, Acute NPM1 mutated myeloid leukemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZE63-0302 or placeboDrug

    The participants will receive ZE63-0302 or placebo

Study groups in NCT06780124
Study groupRoleWhat they receive
Level 1 Single doseExperimentalDose level 1: 6 participants will receive 20 mg ZE63-0302 and 2 participants will receive placebo under fasted conditions.
Receives: Drug: ZE63-0302 or placebo
Level 2 Single doseExperimentalDose level 2: 6 participants will receive 100 mg ZE63-0302 and 2 participants will receive placebo under fasted conditions.
Receives: Drug: ZE63-0302 or placebo
Level 3 Single doseExperimentalDose level 3: 6 participants will receive 300 mg ZE63-0302 and 2 participants will receive placebo under fasted conditions.
Receives: Drug: ZE63-0302 or placebo
Level 4 Single doseExperimentalDose level 4: 6 participants will receive 600 mg ZE63-0302 and 2 participants will receive placebo under fasted conditions.
Receives: Drug: ZE63-0302 or placebo
Level 5 Single doseExperimentalDose level 5: 9 participants will receive 300 mg ZE63-0302 and 3 participants will receive placebo under fed conditions.
Receives: Drug: ZE63-0302 or placebo
Level 6 Single doseExperimentalDose level 6: 6 participants will receive 600 mg ZE63-0302 plus itraconazole and 2 participants will receive placebo plus itraconazole under fasted conditions.
Receives: Drug: ZE63-0302 or placebo
Level 7 Single doseExperimentalDose level 7: 3 participants will receive 600 mg ZE63-0302 and 1 participant will receive placebo under fed conditions.
Receives: Drug: ZE63-0302 or placebo
Level 1 Multiple dosesExperimentalDose level 1: 6 participants will receive 600 mg ZE63-0302 and 2 participants will receive placebo once daily under fasted and/or fed conditions. Duration of dosing (ZE63-0302 or placebo) is 7 days.
Receives: Drug: ZE63-0302 or placebo
Level 2 Multiple dosesExperimentalDose level 2: 6 participants will receive 300 mg ZE63-0302 and 2 participants will receive placebo twice daily under fasted and/or fed conditions. Duration of dosing (ZE63-0302 or placebo) is 7 days.
Receives: Drug: ZE63-0302 or placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plasma pharmacokinetics of ZE63-0302

    Plasma concentration, ng/mL

    Measured: Within 15 min prior to dosing with ZE63-0302/placebo to 168 hours post-dose for SAD . Within 15 min prior to dosing with ZE63-0302/placebo to 264 hours post-dose for MAD.

  2. Effect of BMI on the PK of ZE63-0302 in plasma following administration of single oral doses (for dose levels 5 and 6 only)

    Plasma concentration, ng/mL

    Measured: Within 15 min prior to dosing with ZE63-0302/placebo to 168 h post-dose.

Secondary outcomes (1)

  1. Incidence of adverse events (AEs)

    Incidence of AEs/SAEs (serious adverse events)including significant changes from baseline in body weight, vital signs, electrocardiogram parameters and laboratory assessments qualifying and reported as AEs.

    Measured: From the signing of the consent form until day 8 for SAD dose levels 1-5 and 7 and until day 11 for SAD dose level 6 and until day 18 for MAD.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2025
  2. Study start12 Apr 2024
  3. Primary completion24 Jun 2025
  4. Study completion7 Nov 2025

Resources

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
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06780124
Sponsor's protocol ID
ZE63-0302-0001
Status last verified
Jan 2026
First submitted
13 Jan 2025
Last updated
22 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study of Healthy, run by Eilean Therapeutics at 1 site in Australia.

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 17 inclusion and 30 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 22 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 Australia. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Plasma pharmacokinetics of ZE63-0302 (time frame: Within 15 min prior to dosing with ZE63-0302/placebo to 168 hours post-dose for SAD . Within 15 min prior to dosing with ZE63-0302/placebo to 264 hours post-dose for MAD.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06780124.

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 22 Jan 2026.

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