Healthy VolunteersPhase 1NCT07527221
Safety and Tolerability of ZE74-0282 in Healthy Volunteers
A Phase 1 study of Healthy Volunteers, run by Eilean Therapeutics AU Pty Ltd at 1 site in Australia.
Trial summary
This first-in-human, randomized, double-blind, placebo-controlled Phase 1 study evaluates the safety, tolerability, and pharmacokinetics of single, split, and multiple oral doses of ZE74-0282 under fasted or fed conditions in healthy adult 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 Volunteers
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteAustralia
- Study dates
- 16 Apr 2026to Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers will be included in the study if they satisfy all of the following criteria:
- 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) ≥18.0 and ≤32.0 kg/m2, with a body weight ≤100 kg at Screening.
- Medically healthy (in the opinion of the PI or delegate), as determined by pre-study medical history, and without CS abnormalities including the following:
- Physical examination without any clinically relevant findings;
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- Systolic blood pressure in the range of 90 to 160 mmHg and diastolic blood pressure in the range of 50 to 95 mmHg after resting for 5 minutes in a semi-supine or supine position.
- Pulse rate in the range of 45 to 100 beats per minute after 5 minutes resting in a semi-supine or supine position.
- Body temperature (tympanic), between 35.5°C and 37.7°C.
- Electrocardiogram without CS abnormalities including QTcF <450 msec.
- Female volunteers:
- Must be of non childbearing potential i.e., surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy) at least 6 weeks before the screening visit or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause and a follicle stimulating hormone [FSH] level consistent with postmenopausal status, per local laboratory guidelines), or
- If of childbearing potential, must:
- Have a negative pregnancy test at the screening visit and on admission to the study site on Day -1.
- Agree not to attempt to become pregnant or donate ova from signing the ICF until at least 30 days after the last dose of study drug.
- Agree to use adequate contraception (defined as use of a condom by the male partner combined with use of a highly effective method of contraception [Section 10.4.3]) from the time of consent/screening until at least 30 days after the last dose of study drug, if not exclusively in a same-sex relationship or abstinent as a committed lifestyle.
- Male volunteers:
- Must agree not to donate sperm from signing the ICF until at least 90 days after the last dose of study drug.
- If engaging in sexual intercourse with a female partner who could become pregnant, must agree to use adequate contraception (defined as use of a condom combined with use of a highly effective method of contraception) from signing the ICF until at least 90 days after the last dose of study drug.
- If engaging in sexual intercourse with a female partner who is not of childbearing potential or a same-sex partner, must agree to use a condom from signing the ICF until at least 5 days after the last dose of study drug.
- Have suitable venous access for blood sampling.
- Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
Who cannot join
- Healthy volunteers will be excluded from the study if there is evidence of any of the following at the screening visit or prior to dosing at the timepoint in the SoA:
- History of anaphylaxis or other significant allergy which, in the opinion of the PI (or delegate), would interfere with the volunteer's ability to participate in the study.
- History or presence of CS cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder, including any acute illness, within the past 3 months determined by the PI (or delegate) to be clinically relevant.
- History of surgery or hospitalisation within 3 months prior to screening, or surgery planned during the study.
- Any history of malignant disease in the last 10 years (excludes surgically resected skin squamous cell or basal cell carcinoma with histopathologically-confirmed clear margins).
- Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia.
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- History of risk factors for torsade de pointes (including a family history of long QT syndrome or sudden cardiac death) or a known arrythmia.
- Presence or having sequelae of gastrointestinal, liver (including Gilbert's syndrome), kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- Liver function test results elevated more than 1.5 fold above the ULN for gamma glutamyl transferase, bilirubin (total, conjugated and unconjugated), ALP, AST or ALT. Volunteers with ALP and/or ALT/AST above the limits specified may be included, at the discretion of the PI (or delegate), if the levels are unaccompanied by clinical signs and are determined to be normal variants.
- Estimated creatinine clearance <60 mL/min using the Cockcroft-Gault formula or serum creatinine >1.5 fold above the ULN.
- A history of or positive test results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies at the screening visit.
- Positive drugs of abuse test or alcohol breath test results at the screening visit and/or on admission to the study site on Day 1. Note that positive carbon monoxide test at Screening is not exclusionary.
- Regular consumption of more than 10 standard alcoholic drinks/week and/or more than 4 standard alcoholic drinks on any one day, where 1 standard drink is 10 g of pure alcohol and is equivalent to 285 mL beer [4.9% Alc/Vol], 100 mL wine [12% Alc/Vol], or 30 mL spirit [40% Alc/Vol]).
- Participants must be nonsmokers (including tobacco, nicotine replacement therapy, e-cigarettes and marijuana) for at least 3 months prior to the dose of study drug, have a negative carbon monoxide test at Screening and check-in (Day -1) to the clinical facility and refrain from smoking for the duration of the study. Note that positive carbon monoxide test at Screening is not exclusionary.
- Females who are breastfeeding or are planning to breastfeed from screening until 3 months after the dose of study drug (or 5 × half-lives, whichever is longer).
- Unable to swallow oral medication
- Use of any prescription or over-the-counter medication (including oral contraceptives herbal products, nutritional supplements, diet aids, vitamin supplements, minerals and hormone supplements) within 7 days or 5 half-lives of the medication (whichever is longer) prior to the dose of study drug, except the 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 in one week.
- Current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medication within 10 days prior to dose of study drug.
- Use of inactivated vaccines within 14 days or live vaccines within 30 days prior to the study drug administration and during the study.
- Participants must not take systemic immunosuppressive (e.g., corticosteroids, methotrexate, azathioprine, cyclosporine) or immunomodulating medications (e.g., interferon) within 28 days or 5 half-lives of any relevant agent(s) (whichever is longer) prior to dosing and during the study.
- Donation of blood or plasma within 30 days prior to dosing of study drug, or loss of whole blood of more than 500 mL within 30 days prior to first dose of study drug, or receipt of a blood transfusion within 1 year of the first dose of study drug.
- Participation in a clinical study of an investigational drug or investigational device within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior to screening.
- Any other condition or prior therapy that in the opinion of the PI (or delegate) 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Scientia Clinical Research Ltd.
Randwick, New South Wales, 2031
Christopher Argent, Dr., 02 9382 5844, christopher.argent@scientiaclinicalresearch.com.au
About this study
Official title: A Double-Blind, Placebo-Controlled, First-in-Human Study of the Safety, Tolerability, and Pharmacokinetics of ZE74-0282 in Healthy Volunteers
This first-in-human, randomized, double-blind, placebo-controlled Phase 1 study evaluates the safety, tolerability, and pharmacokinetics of single, split, and multiple oral doses of ZE74-0282 under fasted or fed conditions in healthy adult volunteers.
Read the detailed description
This is a double-blind, randomized, placebo-controlled, first-in-human Phase 1 study evaluating the safety, tolerability, and pharmacokinetics of ZE74-0282 in healthy adult volunteers. A total of up to 64 participants are planned: 48 participants in Part A and 16 participants in Part B. Each cohort will enroll 8 participants, with 6 randomized to ZE74-0282 and 2 randomized to matching placebo. Dose levels and cohort progression will be reviewed sequentially by the Safety Review Committee based on blinded safety and available pharmacokinetic data.
Part A comprises Cohorts 1, 2, 2a, 3, 4, and 5. It evaluates single ascending doses and, where selected by the Safety Review Committee, split or twice-daily dosing on Day 1. Cohort 2a evaluates 75 mg twice daily, administered 12 hours (+/- 30 minutes) apart on Day 1, for a total daily dose of 150 mg. Dosing in each Part A cohort begins with 2 sentinel participants before dosing the remaining participants. Part A participants are confined from Day -1 through Day 4 and complete the end-of-study visit on Day 8 (+/- 1 day).
Part B comprises Cohorts 6 and 7 and evaluates multiple ascending doses for 7 days. Cohort 6 receives 75 mg twice daily and Cohort 7 receives 150 mg twice daily. Doses are administered approximately 12 hours (+/- 30 minutes) apart on Days 1 through 6, with a morning dose only on Day 7, for a total of 13 doses. Part B participants are confined from Day -1 through Day 8, have a follow-up telephone call on Day 11, and complete the end-of-study visit on Day 18 (+/- 1 day).
- Conditions
- Healthy Volunteers
- Being tested
- ZE74-0282-0001 or placebo
- Keywords
- myelofibrosis, polycythaemia vera, essential thrombocytosis, chronic myeloid leukemia
- Medical subject headings
- Primary Myelofibrosis, Polycythemia, Thrombocythemia, Essential, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZE74-0282-0001 or placeboDrug
The participant will receive ZE74-0282-0001 or placebo
| Study group | Role | What they receive |
|---|---|---|
| Part A - Cohort 1: 75 mg single dose | Experimental | Eight participants will be randomized 3:1: 6 participants to a single oral 75 mg dose of ZE74-0282 and 2 participants to matching placebo on Day 1 under fasted conditions. Receives: Drug: ZE74-0282-0001 or placebo |
| Part A - Cohort 2: nominal 150 mg single dose | Experimental | Eight participants will be randomized 3:1: 6 participants to the Safety Review Committee-confirmed oral ZE74-0282 dose (nominally 150 mg) and 2 participants to matching placebo on Day 1. Fasted or fed conditions will be selected based on Safety Review Committee review. Receives: Drug: ZE74-0282-0001 or placebo |
| Part A - Cohort 2a: 75 mg BID split dose | Experimental | Eight participants will be randomized 3:1: 6 participants to ZE74-0282 and 2 participants to matching placebo. Two oral doses will be administered on Day 1: 75 mg at Hour 0 and 75 mg 12 hours (+/- 30 minutes) later, for a total daily dose of 150 mg. Receives: Drug: ZE74-0282-0001 or placebo |
| Part A - Cohort 3: nominal 225 mg | Experimental | Eight participants will be randomized 3:1: 6 participants to ZE74-0282 and 2 participants to matching placebo. The Safety Review Committee will confirm the dose and whether it is administered once or as divided twice-daily doses on Day 1, and whether dosing is under fasted or fed conditions. The nominal dose level is 225 mg. Receives: Drug: ZE74-0282-0001 or placebo |
| Part A - Cohort 4: nominal 300 mg | Experimental | Eight participants will be randomized 3:1: 6 participants to ZE74-0282 and 2 participants to matching placebo. The Safety Review Committee will confirm the dose and whether it is administered once or as divided twice-daily doses on Day 1, and whether dosing is under fasted or fed conditions. The nominal dose level is 300 mg. Receives: Drug: ZE74-0282-0001 or placebo |
| Part A - Cohort 5: nominal 375 mg | Experimental | Eight participants will be randomized 3:1: 6 participants to ZE74-0282 and 2 participants to matching placebo. The Safety Review Committee will confirm the dose and whether it is administered once or as divided twice-daily doses on Day 1, and whether dosing is under fasted or fed conditions. The nominal dose level is 375 mg. Receives: Drug: ZE74-0282-0001 or placebo |
| Part B - Cohort 6: 75 mg BID for 7 days | Experimental | Eight participants will be randomized 3:1: 6 participants to ZE74-0282 and 2 participants to matching placebo. Participants will receive 75 mg twice daily approximately 12 hours (+/- 30 minutes) apart on Days 1 through 6 and one 75 mg morning dose on Day 7, for a total of 13 doses. Receives: Drug: ZE74-0282-0001 or placebo |
| Part B - Cohort 7: 150 mg BID for 7 days | Experimental | Eight participants will be randomized 3:1: 6 participants to ZE74-0282 and 2 participants to matching placebo. Participants will receive 150 mg twice daily approximately 12 hours (+/- 30 minutes) apart on Days 1 through 6 and one 150 mg morning dose on Day 7, for a total of 13 doses. Receives: Drug: ZE74-0282-0001 or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AEs/SAEs
Number of participants with Adverse Events (AEs), serious Adverse Events (SAEs) (including withdrawals due to AEs)
Measured: Baseline to Day 8
Change from Baseline in body weight
A measure of change from Baseline in body weight
Measured: Baseline to Day 8
Change from Baseline in blood pressure
A measure of change from Baseline in blood pressure
Measured: Baseline to Day 8
Change from Baseline in electrocardiogram (ECG) QT interval
A measure of change from Baseline in ECG QT interval
Measured: Baseline to Day 8
Change from Baseline in haematology parameters
Change from baseline in Haematocrit, Haemoglobin, Mean corpuscular haemoglobin, Mean corpuscular haemoglobin concentration, Mean corpuscular volume, Mean platelet volume, Packed cell volume, Platelet count, Red blood cell count, Reticulocyte count, White blood cell count.
Measured: Baseline to Day 8
Change from Baseline in pulse rate
A measure of change from Baseline in pulse rate
Measured: Baseline to Day 8
Change from Baseline in respiratory rate
A measure of change from Baseline in respiratory rate
Measured: Baseline to Day 8
Change from Baseline in temperature
A measure of change from Baseline in temperature
Measured: Baseline to Day 8
Change from Baseline in clinical chemistry parameters
Change from baseline in Albumin, Alkaline phosphatase, Alanine aminotransferase, Amylase, Anion gap, Aspartate aminotransferase, Bicarbonate, Calcium, Ionised calcium, Chloride, Conjugated (direct) bilirubin, Creatinine, Creatinine kinase.
Measured: Baseline to Day 8
Change from baseline in coagulation parameters
Change from baseline in Activated partial thromboplastin time, Fibrinogen, International normalised ratio/ Prothrombin time
Measured: Baseline to Day 8
Change from Baseline in urinalysis parameters
Change from baseline in Bilirubin, Blood, Glucose, Ketones, Leukocyte esterase, Nitrite, pH, Protein, Specific gravity, Urobilinogen.
Measured: Baseline to Day 8
Secondary outcomes (14)
Maximum observed plasma concentration
To assess maximum observed plasma concentration
Measured: PK samples will be collected from Day 1 to Day 4 and on Day 8
Time to Cmax
To assess time to Cmax
Measured: PK samples will be collected from Day 1 to Day 4 and on Day 8
Area under the concentration-time curve from 0 to time of last quantifiable concentration
To assess area under the concentration-time curve from 0 to time of last quantifiable concentration
Measured: PK samples will be collected from Day 1 to Day 4 and on Day 8
Area under the concentration-time curve from 0 to 24 hours
To assess area under the concentration-time curve from 0 to 24 hours
Measured: PK samples will be collected from Day 1 to Day 4 and on Day 8
Area under the concentration-time curve from 0 to infinity
To assess area under the concentration-time curve from 0 to infinity
Measured: PK samples will be collected from Day 1 to Day 4 and on Day 8
Apparent terminal elimination half-life
To assess apparent terminal elimination half-life
Measured: PK samples will be collected from Day 1 to Day 4 and on Day 8
Terminal elimination rate constant
To assess terminal elimination rate constant
Measured: PK samples will be collected from Day 1 to Day 4 and on Day 8
Total apparent body clearance following oral administration
To assess total apparent body clearance following oral administration
Measured: PK samples will be collected from Day 1 to Day 4 and on Day 8
Apparent volume of distribution following oral administration
To assess apparent volume of distribution following oral administration
Measured: PK samples will be collected from Day 1 to Day 4 and on Day 8
Trough plasma concentration (Ctrough) - Part B
Plasma concentration immediately before the next scheduled dose during multiple dosing.
Measured: Predose on Day 1 through 264 hours after the Day 7 morning dose (Day 18).
Apparent steady-state clearance - Part B
Apparent clearance of ZE74-0282 at steady state following repeated oral administration.
Measured: Predose on Day 1 through 264 hours after the Day 7 morning dose (Day 18).
Apparent steady-state volume of distribution (Vss/F) - Part B
Apparent volume of distribution of ZE74-0282 at steady state following repeated oral administration.
Measured: Predose on Day 1 through 264 hours after the Day 7 morning dose (Day 18).
Accumulation ratio based on Cmax (RCmax) - Part B
Ratio of Cmax after repeated dosing to Cmax after the first dose.
Measured: Predose on Day 1 through 264 hours after the Day 7 morning dose (Day 18).
Accumulation ratio based on AUC0-12 (RAUC) - Part B
Ratio of AUC0-12 after repeated dosing to AUC0-12 after the first dose.
Measured: Predose on Day 1 through 264 hours after the Day 7 morning dose (Day 18).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start16 Apr 2026
- Primary completionNov 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one protocol cohort and randomized to ZE74-0282 or placebo. Cohorts are opened sequentially based on Safety Review Committee review of blinded safety and available PK data.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eilean Therapeutics AU Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07527221
- Sponsor's protocol ID
- ZE74-0282-0001
- Status last verified
- Jul 2026
- First submitted
- 23 Mar 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- 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 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, First-in-Human Study of the Safety, Tolerability, and Pharmacokinetics of ZE74-0282 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07527221
- Acronym / sponsor ID
- ZE74-0282-0001
- Conditions
- Healthy Volunteers
- Keywords
- myelofibrosis, polycythaemia vera, essential thrombocytosis, chronic myeloid leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Eilean Therapeutics AU Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 16 Apr 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This first-in-human, randomized, double-blind, placebo-controlled Phase 1 study evaluates the safety, tolerability, and pharmacokinetics of single, split, and multiple oral doses of ZE74-0282 under fasted or fed conditions in healthy adult volunteers.
Detailed description
This is a double-blind, randomized, placebo-controlled, first-in-human Phase 1 study evaluating the safety, tolerability, and pharmacokinetics of ZE74-0282 in healthy adult volunteers. A total of up to 64 participants are planned: 48 participants in Part A and 16 participants in Part B. Each cohort will enroll 8 participants, with 6 randomized to ZE74-0282 and 2 randomized to matching placebo. Dose levels and cohort progression will be reviewed sequentially by the Safety Review Committee based on blinded safety and available pharmacokinetic data.
Part A comprises Cohorts 1, 2, 2a, 3, 4, and 5. It evaluates single ascending doses and, where selected by the Safety Review Committee, split or twice-daily dosing on Day 1. Cohort 2a evaluates 75 mg twice daily, administered 12 hours (+/- 30 minutes) apart on Day 1, for a total daily dose of 150 mg. Dosing in each Part A cohort begins with 2 sentinel participants before dosing the remaining participants. Part A participants are confined from Day -1 through Day 4 and complete the end-of-study visit on Day 8 (+/- 1 day).
Part B comprises Cohorts 6 and 7 and evaluates multiple ascending doses for 7 days. Cohort 6 receives 75 mg twice daily and Cohort 7 receives 150 mg twice daily. Doses are administered approximately 12 hours (+/- 30 minutes) apart on Days 1 through 6, with a morning dose only on Day 7, for a total of 13 doses. Part B participants are confined from Day -1 through Day 8, have a follow-up telephone call on Day 11, and complete the end-of-study visit on Day 18 (+/- 1 day).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
- Model description
- Participants are assigned to one protocol cohort and randomized to ZE74-0282 or placebo. Cohorts are opened sequentially based on Safety Review Committee review of blinded safety and available PK data.
| Arm | Type | Receives |
|---|---|---|
| Part A - Cohort 1: 75 mg single dose | Experimental | Drug: ZE74-0282-0001 or placeboEight participants will be randomized 3:1: 6 participants to a single oral 75 mg dose of ZE74-0282 and 2 participants to matching placebo on Day 1 under fasted conditions. |
| Part A - Cohort 2: nominal 150 mg single dose | Experimental | Drug: ZE74-0282-0001 or placeboEight participants will be randomized 3:1: 6 participants to the Safety Review Committee-confirmed oral ZE74-0282 dose (nominally 150 mg) and 2 participants to matching placebo on Day 1. Fasted or fed conditions will be selected based on Safety Review Committee review. |
| Part A - Cohort 2a: 75 mg BID split dose | Experimental | Drug: ZE74-0282-0001 or placeboEight participants will be randomized 3:1: 6 participants to ZE74-0282 and 2 participants to matching placebo. Two oral doses will be administered on Day 1: 75 mg at Hour 0 and 75 mg 12 hours (+/- 30 minutes) later, for a total daily dose of 150 mg. |
| Part A - Cohort 3: nominal 225 mg | Experimental | Drug: ZE74-0282-0001 or placeboEight participants will be randomized 3:1: 6 participants to ZE74-0282 and 2 participants to matching placebo. The Safety Review Committee will confirm the dose and whether it is administered once or as divided twice-daily doses on Day 1, and whether dosing is under fasted or fed conditions. The nominal dose level is 225 mg. |
| Part A - Cohort 4: nominal 300 mg | Experimental | Drug: ZE74-0282-0001 or placeboEight participants will be randomized 3:1: 6 participants to ZE74-0282 and 2 participants to matching placebo. The Safety Review Committee will confirm the dose and whether it is administered once or as divided twice-daily doses on Day 1, and whether dosing is under fasted or fed conditions. The nominal dose level is 300 mg. |
| Part A - Cohort 5: nominal 375 mg | Experimental | Drug: ZE74-0282-0001 or placeboEight participants will be randomized 3:1: 6 participants to ZE74-0282 and 2 participants to matching placebo. The Safety Review Committee will confirm the dose and whether it is administered once or as divided twice-daily doses on Day 1, and whether dosing is under fasted or fed conditions. The nominal dose level is 375 mg. |
| Part B - Cohort 6: 75 mg BID for 7 days | Experimental | Drug: ZE74-0282-0001 or placeboEight participants will be randomized 3:1: 6 participants to ZE74-0282 and 2 participants to matching placebo. Participants will receive 75 mg twice daily approximately 12 hours (+/- 30 minutes) apart on Days 1 through 6 and one 75 mg morning dose on Day 7, for a total of 13 doses. |
| Part B - Cohort 7: 150 mg BID for 7 days | Experimental | Drug: ZE74-0282-0001 or placeboEight participants will be randomized 3:1: 6 participants to ZE74-0282 and 2 participants to matching placebo. Participants will receive 150 mg twice daily approximately 12 hours (+/- 30 minutes) apart on Days 1 through 6 and one 150 mg morning dose on Day 7, for a total of 13 doses. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (22 listed)
- Healthy volunteers will be included in the study if they satisfy all of the following criteria:
Key exclusion criteria (23 listed)
- Healthy volunteers will be excluded from the study if there is evidence of any of the following at the screening visit or prior to dosing at the timepoint in the SoA:
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 |
|---|---|---|
| ZE74-0282-0001 or placeboThe participant will receive ZE74-0282-0001 or placebo | Drug | Part A - Cohort 1: 75 mg single dose, Part A - Cohort 2: nominal 150 mg single dose, Part A - Cohort 2a: 75 mg BID split dose, Part A - Cohort 3: nominal 225 mg, Part A - Cohort 4: nominal 300 mg, Part A - Cohort 5: nominal 375 mg, Part B - Cohort 6: 75 mg BID for 7 days, Part B - Cohort 7: 150 mg BID for 7 days |
Primary outcome
Incidence of AEs/SAEs
Time frame: Baseline to Day 8
Number of participants with Adverse Events (AEs), serious Adverse Events (SAEs) (including withdrawals due to AEs)
Change from Baseline in body weight
Time frame: Baseline to Day 8
A measure of change from Baseline in body weight
Change from Baseline in blood pressure
Time frame: Baseline to Day 8
A measure of change from Baseline in blood pressure
Change from Baseline in electrocardiogram (ECG) QT interval
Time frame: Baseline to Day 8
A measure of change from Baseline in ECG QT interval
Change from Baseline in haematology parameters
Time frame: Baseline to Day 8
Change from baseline in Haematocrit, Haemoglobin, Mean corpuscular haemoglobin, Mean corpuscular haemoglobin concentration, Mean corpuscular volume, Mean platelet volume, Packed cell volume, Platelet count, Red blood cell count, Reticulocyte count, White blood cell count.
Change from Baseline in pulse rate
Time frame: Baseline to Day 8
A measure of change from Baseline in pulse rate
Change from Baseline in respiratory rate
Time frame: Baseline to Day 8
A measure of change from Baseline in respiratory rate
Change from Baseline in temperature
Time frame: Baseline to Day 8
A measure of change from Baseline in temperature
Change from Baseline in clinical chemistry parameters
Time frame: Baseline to Day 8
Change from baseline in Albumin, Alkaline phosphatase, Alanine aminotransferase, Amylase, Anion gap, Aspartate aminotransferase, Bicarbonate, Calcium, Ionised calcium, Chloride, Conjugated (direct) bilirubin, Creatinine, Creatinine kinase.
Change from baseline in coagulation parameters
Time frame: Baseline to Day 8
Change from baseline in Activated partial thromboplastin time, Fibrinogen, International normalised ratio/ Prothrombin time
Change from Baseline in urinalysis parameters
Time frame: Baseline to Day 8
Change from baseline in Bilirubin, Blood, Glucose, Ketones, Leukocyte esterase, Nitrite, pH, Protein, Specific gravity, Urobilinogen.
14 secondary outcomes
Maximum observed plasma concentration
Time frame: PK samples will be collected from Day 1 to Day 4 and on Day 8
Time to Cmax
Time frame: PK samples will be collected from Day 1 to Day 4 and on Day 8
Area under the concentration-time curve from 0 to time of last quantifiable concentration
Time frame: PK samples will be collected from Day 1 to Day 4 and on Day 8
Area under the concentration-time curve from 0 to 24 hours
Time frame: PK samples will be collected from Day 1 to Day 4 and on Day 8
Area under the concentration-time curve from 0 to infinity
Time frame: PK samples will be collected from Day 1 to Day 4 and on Day 8
Apparent terminal elimination half-life
Time frame: PK samples will be collected from Day 1 to Day 4 and on Day 8
Terminal elimination rate constant
Time frame: PK samples will be collected from Day 1 to Day 4 and on Day 8
Total apparent body clearance following oral administration
Time frame: PK samples will be collected from Day 1 to Day 4 and on Day 8
Apparent volume of distribution following oral administration
Time frame: PK samples will be collected from Day 1 to Day 4 and on Day 8
Trough plasma concentration (Ctrough) - Part B
Time frame: Predose on Day 1 through 264 hours after the Day 7 morning dose (Day 18).
Apparent steady-state clearance - Part B
Time frame: Predose on Day 1 through 264 hours after the Day 7 morning dose (Day 18).
Apparent steady-state volume of distribution (Vss/F) - Part B
Time frame: Predose on Day 1 through 264 hours after the Day 7 morning dose (Day 18).
Accumulation ratio based on Cmax (RCmax) - Part B
Time frame: Predose on Day 1 through 264 hours after the Day 7 morning dose (Day 18).
Accumulation ratio based on AUC0-12 (RAUC) - Part B
Time frame: Predose on Day 1 through 264 hours after the Day 7 morning dose (Day 18).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
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Screening Protocol
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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.
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 of Healthy Volunteers, run by Eilean Therapeutics AU Pty Ltd 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 22 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 28 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ekaterina Dokukina (+1 858 353 4108, kdokukina@eilenther.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AEs/SAEs (time frame: Baseline to Day 8). The study lists 11 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 Jul 2026.