A Phase 1 interventional study of ZE66-0205 and Placebo in Healthy Volunteers (HV), sponsored by Eilean Therapeutics. Recruiting at 1 site in Australia. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Eilean Therapeutics · Phase 1, Interventional, and Other
This first-in-human study will evaluate ZE66-0205 in healthy adults. The main purpose is to assess the safety and tolerability of single oral doses and, if evaluated, two doses given on Day 1. The study will also assess how ZE66-0205 is absorbed, distributed, and eliminated from the body and how it affects MALT1 levels in blood cells. Participants will be assigned by chance to receive ZE66-0205 or placebo in sequential ascending-dose cohorts.
This is a Phase 1, randomised, double-blind, placebo-controlled, first-in-human study in healthy male and female adult volunteers. The study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ZE66-0205, a novel orally administered small-molecule degrader of mucosa-associated lymphoid tissue lymphoma translocation protein 1 (MALT1).
Up to 32 participants are planned to be enrolled in four sequential dose-escalation cohorts. Each cohort will include 8 participants, with 6 participants randomised to ZE66-0205 and 2 participants randomised to matching placebo. The starting dose is 50 mg. The nominal dose levels for Cohorts 2, 3, and 4 are 100 mg, 200 mg, and 300 mg, respectively; however, the dose level for each subsequent cohort may be adjusted by the Safety Review Committee (SRC) after review of blinded safety and available PK and PD data. Sequential dose escalation will generally not exceed a 2-fold increase, except that escalation from Cohort 1 to Cohort 2 may be up to 4-fold based on emerging PK data.
Dosing within each cohort will begin with 2 sentinel participants, with 1 sentinel assigned to ZE66-0205 and 1 assigned to placebo. Sentinel safety and tolerability data through Day 3 will be reviewed before the remaining participants in the cohort are dosed. The SRC will review all available blinded safety data through the End-of-Study visit and available blinded PK data before recommending escalation, dose adjustment, repetition of a dose level, evaluation of fed conditions or twice-daily dosing, addition of another cohort, or termination of enrolment. Additional higher-dose, food-effect, or twice-daily cohorts may be added as permitted by the protocol. Evaluation of CYP3A4 interaction or the effect of a proton pump inhibitor would require a protocol amendment before implementation.
Participants will be screened from Day -28 to Day -2, admitted to the clinical facility on Day -1, dosed on Day 1, and remain confined through Day 4. A follow-up telephone call will occur between Days 5 and 7, and the End-of-Study visit will occur on Day 8 (plus or minus 1 day). Safety assessments include adverse-event monitoring, physical examinations, body weight, vital signs, 12-lead electrocardiograms, and clinical laboratory testing. Blood samples for PK and PD assessments will be collected through approximately 168 hours after dosing.
Eilean Therapeutics is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
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.
Exclusion Criteria:
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.
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.
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.
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.
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.
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.
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.
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.
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.
Matching placebo. Two participants in each planned cohort will receive placebo capsules that match ZE66-0205 in appearance. Placebo will be administered orally under the same dosing and meal conditions as the corresponding active cohort. If twice-daily dosing is evaluated, placebo participants will receive a second dose approximately 12 hours after the first dose.
Drug: Placebo
ZE66-0205 50 mg. Six participants will receive a single oral 50 mg dose on Day 1 under fasted conditions.
Drug: ZE66-0205
ZE66-0205 nominal 100 mg. Six participants will receive the SRC-confirmed oral dose on Day 1. The nominal dose is 100 mg; the actual dose may be adjusted based on emerging safety, PK, and PD data. Fed conditions or twice-daily dosing may be evaluated if selected by the SRC.
Drug: ZE66-0205
ZE66-0205 nominal 200 mg. Six participants will receive the SRC-confirmed oral dose on Day 1. The nominal dose is 200 mg; the actual dose may be adjusted based on emerging safety, PK, and PD data. Fed conditions or twice-daily dosing may be evaluated if selected by the SRC.
Drug: ZE66-0205
ZE66-0205 nominal 300 mg. Six participants will receive the SRC-confirmed oral dose on Day 1. The nominal dose is 300 mg; the actual dose may be adjusted based on emerging safety, PK, and PD data. Fed conditions or twice-daily dosing may be evaluated if selected by the SRC.
Drug: ZE66-0205
ZE66-0205 oral soft gelatin capsules, 50 mg strength. Participants will receive the assigned total dose orally with approximately 240 mL of water. Planned nominal single-dose levels are 50 mg, 100 mg, 200 mg, and 300 mg. If twice-daily dosing is evaluated, a second dose will be administered approximately 12 hours after the morning dose.
Placebo formulation not containing the active drug
Incidence of treatment-emergent adverse events (TEAEs)
Number and percentage of participants with one or more TEAEs. Events will be summarised by severity and relationship to study drug; adverse events leading to withdrawal will also be reported.
Time frame: From the first dose on Day 1 through the End-of-Study visit on Day 8 (±1 day)
Incidence of serious adverse events (SAEs)
Number and percentage of participants with one or more SAEs, including severity and relationship to study drug.
Time frame: From the first dose on Day 1 through the End-of-Study visit on Day 8 (±1 day)
Change from Baseline in body weight
Observed body weight and change from the Day 1 pre-dose Baseline, measured in kilograms.
Time frame: Baseline to Day 8 (±1 day)
Change from Baseline in systolic and diastolic blood pressure
Observed values and changes from the Day 1 pre-dose Baseline in systolic and diastolic blood pressure, measured in mmHg.
Time frame: Baseline through Day 8 (±1 day)
Change from Baseline in pulse rate
Observed pulse rate and change from the Day 1 pre-dose Baseline, measured in beats per minute.
Time frame: Baseline through Day 8 (±1 day)
Change from Baseline in respiratory rate
Observed respiratory rate and change from the Day 1 pre-dose Baseline, measured in breaths per minute.
Time frame: Baseline through Day 8 (±1 day)
Change from Baseline in body temperature
Observed body temperature and change from the Day 1 pre-dose Baseline, measured in degrees Celsius.
Time frame: Baseline through Day 8 (±1 day)
Change from Baseline in electrocardiogram parameters
Observed values and changes from the Day 1 pre-dose Baseline in ventricular heart rate, PR interval, QRS duration, QT interval, and QT interval corrected using Fridericia's formula (QTcF).
Time frame: Baseline through Day 8 (±1 day)
Participants with clinically significant post-Baseline clinical laboratory abnormalities
Number and percentage of participants with clinically significant abnormalities in haematology, clinical chemistry, coagulation, or urinalysis. Observed values and changes from the Day 1 pre-dose Baseline will also be summarised.
Time frame: Baseline through Day 8 (±1 day)
Maximum observed plasma concentration (Cmax) of ZE66-0205
Cmax derived from the plasma concentration-time profile of ZE66-0205.
Time frame: Pre-dose through 168 hours post-dose
Time to maximum observed plasma concentration (Tmax) of ZE66-0205
Tmax derived from the plasma concentration-time profile of ZE66-0205.
Time frame: Pre-dose through 168 hours post-dose
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC0-last)
AUC0-last for ZE66-0205 calculated using noncompartmental methods.
Time frame: Pre-dose through 168 hours post-dose
Area under the plasma concentration-time curve from time 0 to 24 hours (AUC0-24)
AUC0-24 for ZE66-0205 calculated using noncompartmental methods.
Time frame: Pre-dose through 24 hours post-dose
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)
AUC0-inf for ZE66-0205 calculated using noncompartmental methods, as data permit.
Time frame: Pre-dose through 168 hours post-dose
Apparent terminal elimination half-life (t1/2) of ZE66-0205
Terminal elimination half-life calculated from the plasma concentration-time profile, as data permit.
Time frame: Pre-dose through 168 hours post-dose
Terminal elimination rate constant (lambda z) of ZE66-0205
Terminal elimination rate constant calculated from the terminal portion of the plasma concentration-time profile, as data permit.
Time frame: Pre-dose through 168 hours post-dose
Total apparent body clearance after oral administration (CL/F) of ZE66-0205
Apparent oral clearance calculated using noncompartmental methods, as data permit.
Time frame: Pre-dose through 168 hours post-dose
Apparent volume of distribution after oral administration (Vz/F) of ZE66-0205
Apparent volume of distribution during the terminal phase calculated using noncompartmental methods, as data permit.
Time frame: Pre-dose through 168 hours post-dose
Change from Baseline in MALT1 level in peripheral blood mononuclear cells (PBMCs)
MALT1 levels in PBMCs will be measured at Screening, before dosing, and after dosing. The Day 1 pre-dose value will be used as Baseline; observed values and changes from Baseline will be summarised.
Time frame: Screening and pre-dose through 168 hours post-dose
Relationship between ZE66-0205 plasma concentrations and MALT1 levels in PBMCs
Where data permit, plasma ZE66-0205 concentrations will be correlated with MALT1 levels in PBMCs as an exploratory PK/PD analysis.
Time frame: Pre-dose through 168 hours post-dose
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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