A Phase 1 interventional study of ZE74-0282-0001 or placebo in Healthy Volunteers, sponsored by Eilean Therapeutics AU Pty Ltd. Recruiting at 1 site in Australia. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Eilean Therapeutics AU Pty Ltd · Phase 1, Interventional, and Other
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.
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).
625 studies on the registry are indexed under Primary Myelofibrosis; 124 are open to participants now.
This study's planned enrollment of 64 is above the median of 43 across 489 interventional studies indexed under Primary Myelofibrosis.
Browse Primary Myelofibrosis studies →This is the only study on the registry with Eilean Therapeutics AU Pty Ltd as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Healthy volunteers will be included in the study if they satisfy all of the following criteria:
Medically healthy (in the opinion of the PI or delegate), as determined by pre-study medical history, and without CS abnormalities including the following:
Female volunteers:
i. Have a negative pregnancy test at the screening visit and on admission to the study site on Day -1.
ii. 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.
iii. Agree to use adequate (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:
Exclusion Criteria:
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: ZE74-0282-0001 or placebo
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.
Drug: ZE74-0282-0001 or placebo
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.
Drug: ZE74-0282-0001 or placebo
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.
Drug: ZE74-0282-0001 or placebo
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.
Drug: ZE74-0282-0001 or placebo
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.
Drug: ZE74-0282-0001 or placebo
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.
Drug: ZE74-0282-0001 or placebo
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.
Drug: ZE74-0282-0001 or placebo
The participant will receive ZE74-0282-0001 or placebo
Incidence of AEs/SAEs
Number of participants with Adverse Events (AEs), serious Adverse Events (SAEs) (including withdrawals due to AEs)
Time frame: Baseline to Day 8
Change from Baseline in body weight
A measure of change from Baseline in body weight
Time frame: Baseline to Day 8
Change from Baseline in blood pressure
A measure of change from Baseline in blood pressure
Time frame: Baseline to Day 8
Change from Baseline in electrocardiogram (ECG) QT interval
A measure of change from Baseline in ECG QT interval
Time frame: 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.
Time frame: Baseline to Day 8
Change from Baseline in pulse rate
A measure of change from Baseline in pulse rate
Time frame: Baseline to Day 8
Change from Baseline in respiratory rate
A measure of change from Baseline in respiratory rate
Time frame: Baseline to Day 8
Change from Baseline in temperature
A measure of change from Baseline in temperature
Time frame: 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.
Time frame: Baseline to Day 8
Change from baseline in coagulation parameters
Change from baseline in Activated partial thromboplastin time, Fibrinogen, International normalised ratio/ Prothrombin time
Time frame: 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.
Time frame: Baseline to Day 8
Maximum observed plasma concentration
To assess maximum observed plasma concentration
Time frame: PK samples will be collected from Day 1 to Day 4 and on Day 8
Time to Cmax
To assess 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
To assess 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
To assess 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
To assess 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
To assess 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
To assess 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
To assess 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
To assess 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
Plasma concentration immediately before the next scheduled dose during multiple dosing.
Time frame: 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.
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
Apparent volume of distribution of ZE74-0282 at steady state following repeated oral administration.
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
Ratio of Cmax after repeated dosing to Cmax after the first dose.
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
Ratio of AUC0-12 after repeated dosing to AUC0-12 after the first dose.
Time frame: Predose on Day 1 through 264 hours after the Day 7 morning dose (Day 18).
Comparison of trough concentrations after 150 mg single-dose and 75 mg BID split-dose administration
Compare the 24-hour plasma concentration after a single 150 mg dose with the 12-hour plasma concentrations after each 75 mg dose in the split-dose cohort.
Time frame: Predose through 24 hours after the first dose on Day 1.
Comparison of Cmax and AUC0-24 after 150 mg single-dose and 75 mg BID split-dose administration
Compare Cmax and AUC0-24 between the 150 mg single-dose cohort and the 75 mg twice-daily split-dose cohort.
Time frame: Predose through 24 hours after the first dose on Day 1.
Exposure after the second versus first 75 mg dose in the split-dose cohort
For Cohort 2a, compare exposure after the second 75 mg dose with exposure after the first 75 mg dose, including an accumulation ratio where data permit.
Time frame: Part A: Predose through 24 hours after the first dose on Day 1.
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Nov 2026, 7 months after the start.
Of 67 phase 1 interventional studies under Primary Myelofibrosis, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 103. This study's planned 7 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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