Healthy Volunteers (HV)Phase 1NCT07735728
A First-in-Human Study of ZE66-0205 in Healthy Volunteers
A Phase 1 study testing ZE66-0205 in people with Healthy Volunteers (HV), run by Eilean Therapeutics at 1 site in Australia.
Trial summary
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. 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 (HV)
- What is being tested?
- ZE66-0205
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteAustralia
- Study dates
- 15 Aug 2026to 15 Aug 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
- Written informed consent provided before any study-related activities; able to understand the nature, purpose, risks, and possible adverse effects of the study.
- Male or female, 18 to 55 years of age, inclusive, at Screening.
- Body mass index 18.0 to 32.0 kg/m², inclusive, and body weight no more than 100 kg at Screening.
- Medically healthy in the opinion of the Investigator or delegate based on medical history and absence of clinically significant abnormalities, including: no clinically relevant physical-examination findings; systolic blood pressure 90 to 160 mmHg and diastolic blood pressure 50 to 95 mmHg after at least 5 minutes of rest; pulse rate 40 to 100 beats/minute after at least 5 minutes of rest; tympanic body temperature 35.5°C to 37.7°C; and electrocardiogram without clinically significant abnormalities, including QTcF less than 450 msec for males and less than 470 msec for females.
- Female participants must be of non-childbearing potential (surgically sterilised at least 6 weeks before Screening or postmenopausal with confirmatory follicle-stimulating hormone level) or, if of childbearing potential, must have negative pregnancy tests at Screening and Day -1, agree not to become pregnant or donate ova until at least 30 days after the last dose, and use protocol-defined adequate contraception during this period unless exclusively in a same-sex relationship or abstinent as a committed lifestyle.
- Male participants must agree not to donate sperm until at least 90 days after the last dose. When engaging in sexual intercourse with a female partner who could become pregnant, the participant must use a condom together with a protocol-defined highly effective method of contraception until at least 90 days after the last dose. When engaging in sexual intercourse with a female partner who is not of childbearing potential or with a same-sex partner, the participant must use a condom until at least 5 days after the last dose.
- Suitable venous access for blood sampling.
- Willing and able to comply with all study assessments, schedule requirements, and restrictions.
Who cannot join
- History of anaphylaxis or another significant allergy that, in the opinion of the Investigator or delegate, could interfere with study participation.
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric, or neurological disease or disorder, including any clinically relevant acute illness within the previous 3 months.
- Surgery or hospitalization within 3 months before Screening, or planned surgery during the study.
- History of malignant disease within the previous 10 years, except surgically resected squamous-cell or basal-cell skin carcinoma with histopathologically confirmed clear margins.
- Clinically relevant immunosuppression, including immunodeficiency conditions such as common variable hypogammaglobulinemia.
- History of risk factors for torsade de pointes, including family history of long QT syndrome or sudden cardiac death, or a known arrhythmia.
Show all 21Show fewer
- Gastrointestinal, hepatic (including Gilbert syndrome), renal, or other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Gamma-glutamyl transferase, total bilirubin, alkaline phosphatase, aspartate aminotransferase, or alanine aminotransferase greater than 1.5 times the upper limit of normal, unless an isolated elevation is considered a normal variant by the Investigator or delegate and is not accompanied by clinical signs.
- Estimated creatinine clearance below 60 mL/min using the Cockcroft-Gault formula or serum creatinine greater than 1.5 times the upper limit of normal.
- History of or positive Screening test for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus antibodies.
- Positive urine drug-of-abuse test, carbon monoxide breath test, or alcohol breath test at Screening or Day -1.
- Regular smoking of more than 5 cigarettes per week or equivalent, including tobacco, nicotine replacement therapy, e-cigarettes, or marijuana. Casual smokers may be eligible only if all protocol requirements are met.
- Pregnant or breastfeeding female, or female planning to breastfeed from Screening until 3 months after the last dose or 5 half-lives, whichever is longer.
- Unable to swallow oral medication.
- Use of prescription medication, including oral contraceptives, within 14 days or 5 half-lives, whichever is longer, before the first dose; or use of over-the-counter medication within 7 days or 5 half-lives, whichever is longer, before the first dose, except protocol-permitted paracetamol.
- Current infection requiring a systemically absorbed antibiotic, antifungal, antiparasitic, or antiviral medication within 10 days before the first dose.
- Receipt of an inactivated vaccination within 14 days or a live vaccination within 30 days before the first dose, or planned vaccination during the study.
- Use of systemic immunosuppressive or immunomodulating medication within 28 days or 5 half-lives, whichever is longer, before dosing or during the study.
- Blood or plasma donation within 30 days before the first dose; loss of more than 500 mL of whole blood within 30 days before the first dose; or receipt of a blood transfusion within 1 year before the first dose.
- Participation in a clinical study of an investigational drug or device within 30 days or 5 half-lives of the investigational drug, whichever is longer, before Screening.
- Any other condition or prior therapy that, in the opinion of the Investigator or delegate, makes the participant unsuitable for the study, including inability to cooperate fully or likely noncompliance with 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.
Carlo Cervi contact
Australia1 site
Scientia Clinical Research Ltd
Randwick, New South Wales, 2031
Christopher Argent, Dr
About this study
Official title: A Double-Blind, Placebo-Controlled, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZE66-0205 in Healthy Volunteers
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.
Read the detailed description
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.
- Conditions
- Healthy Volunteers (HV)
- Being tested
- ZE66-0205, Placebo
- Keywords
- ZE66-0205, MALT1, MALT1 degrader, proteolysis-targeting chimera, PROTAC, first-in-human, single ascending dose, pharmacokinetics, pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZE66-0205Drug
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.
PlaceboDrug
Placebo formulation not containing the active drug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
| Experimental: Cohort 1 | Experimental | ZE66-0205 50 mg. Six participants will receive a single oral 50 mg dose on Day 1 under fasted conditions. Receives: Drug: ZE66-0205 |
| Experimental: Cohort 2 | Experimental | 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. Receives: Drug: ZE66-0205 |
| Experimental: Cohort 3 | Experimental | 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. Receives: Drug: ZE66-0205 |
| Experimental: Cohort 4 | Experimental | 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. Receives: Drug: ZE66-0205 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline through Day 8 (±1 day)
Secondary outcomes (9)
Maximum observed plasma concentration (Cmax) of ZE66-0205
Cmax derived from the plasma concentration-time profile of ZE66-0205.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-dose through 168 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start15 Aug 2026 (estimated)
- Primary completion15 Aug 2027 (estimated)
- Study completion15 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers (HV)Studies 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
- Sequential
- Model description
- Sequential dose-escalation cohorts will be evaluated from lower to higher dose levels. Within each cohort, participants will be randomized in a 3:1 ratio to ZE66-0205 or matching placebo
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eilean Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ekaterina Dokukina, Study director, Eilean Therapeutics AU Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735728
- Sponsor's protocol ID
- ZE66-0205-0001
- Status last verified
- Aug 2026
- First submitted
- 24 Jul 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 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, Pharmacokinetics, and Pharmacodynamics of ZE66-0205 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07735728
- Acronym / sponsor ID
- ZE66-0205-0001
- Conditions
- Healthy Volunteers (HV)
- Keywords
- ZE66-0205, MALT1, MALT1 degrader, proteolysis-targeting chimera, PROTAC, first-in-human, single ascending dose, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Eilean TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 15 Aug 2027 (estimated)
- Study completion
- 15 Aug 2027 (estimated)
- First posted
- 30 Jul 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 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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 5
- Model description
- Sequential dose-escalation cohorts will be evaluated from lower to higher dose levels. Within each cohort, participants will be randomized in a 3:1 ratio to ZE66-0205 or matching placebo
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboMatching 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. |
| Experimental: Cohort 1 | Experimental | Drug: ZE66-0205ZE66-0205 50 mg. Six participants will receive a single oral 50 mg dose on Day 1 under fasted conditions. |
| Experimental: Cohort 2 | Experimental | Drug: ZE66-0205ZE66-0205 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. |
| Experimental: Cohort 3 | Experimental | Drug: ZE66-0205ZE66-0205 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. |
| Experimental: Cohort 4 | Experimental | Drug: ZE66-0205ZE66-0205 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Written informed consent provided before any study-related activities; able to understand the nature, purpose, risks, and possible adverse effects of the study.
- Male or female, 18 to 55 years of age, inclusive, at Screening.
- Body mass index 18.0 to 32.0 kg/m², inclusive, and body weight no more than 100 kg at Screening.
- Medically healthy in the opinion of the Investigator or delegate based on medical history and absence of clinically significant abnormalities, including: no clinically relevant physical-examination findings; systolic blood pressure 90 to 160 mmHg and diastolic blood pressure 50 to 95 mmHg after at least 5 minutes of rest; pulse rate 40 to 100 beats/minute after at least 5 minutes of rest; tympanic body temperature 35.5°C to 37.7°C; and electrocardiogram without clinically significant abnormalities, including QTcF less than 450 msec for males and less than 470 msec for females.
- Female participants must be of non-childbearing potential (surgically sterilised at least 6 weeks before Screening or postmenopausal with confirmatory follicle-stimulating hormone level) or, if of childbearing potential, must have negative pregnancy tests at Screening and Day -1, agree not to become pregnant or donate ova until at least 30 days after the last dose, and use protocol-defined adequate contraception during this period unless exclusively in a same-sex relationship or abstinent as a committed lifestyle.
Key exclusion criteria (21 listed)
- History of anaphylaxis or another significant allergy that, in the opinion of the Investigator or delegate, could interfere with study participation.
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric, or neurological disease or disorder, including any clinically relevant acute illness within the previous 3 months.
- Surgery or hospitalization within 3 months before Screening, or planned surgery during the study.
- History of malignant disease within the previous 10 years, except surgically resected squamous-cell or basal-cell skin carcinoma with histopathologically confirmed clear margins.
- Clinically relevant immunosuppression, including immunodeficiency conditions such as common variable hypogammaglobulinemia.
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 |
|---|---|---|
| ZE66-0205ZE66-0205 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. | Drug | Experimental: Cohort 1, Experimental: Cohort 2, Experimental: Cohort 3, Experimental: Cohort 4 |
| PlaceboPlacebo formulation not containing the active drug | Drug | Placebo |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: From the first dose on Day 1 through the End-of-Study visit on Day 8 (±1 day)
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.
Incidence of serious adverse events (SAEs)
Time frame: From the first dose on Day 1 through the End-of-Study visit on Day 8 (±1 day)
Number and percentage of participants with one or more SAEs, including severity and relationship to study drug.
Change from Baseline in body weight
Time frame: Baseline to Day 8 (±1 day)
Observed body weight and change from the Day 1 pre-dose Baseline, measured in kilograms.
Change from Baseline in systolic and diastolic blood pressure
Time frame: Baseline through Day 8 (±1 day)
Observed values and changes from the Day 1 pre-dose Baseline in systolic and diastolic blood pressure, measured in mmHg.
Change from Baseline in pulse rate
Time frame: Baseline through Day 8 (±1 day)
Observed pulse rate and change from the Day 1 pre-dose Baseline, measured in beats per minute.
Change from Baseline in respiratory rate
Time frame: Baseline through Day 8 (±1 day)
Observed respiratory rate and change from the Day 1 pre-dose Baseline, measured in breaths per minute.
Change from Baseline in body temperature
Time frame: Baseline through Day 8 (±1 day)
Observed body temperature and change from the Day 1 pre-dose Baseline, measured in degrees Celsius.
Change from Baseline in electrocardiogram parameters
Time frame: Baseline through Day 8 (±1 day)
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).
Participants with clinically significant post-Baseline clinical laboratory abnormalities
Time frame: Baseline through Day 8 (±1 day)
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.
9 secondary outcomes
Maximum observed plasma concentration (Cmax) of ZE66-0205
Time frame: Pre-dose through 168 hours post-dose
Time to maximum observed plasma concentration (Tmax) 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)
Time frame: Pre-dose through 168 hours post-dose
Area under the plasma concentration-time curve from time 0 to 24 hours (AUC0-24)
Time frame: Pre-dose through 24 hours post-dose
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)
Time frame: Pre-dose through 168 hours post-dose
Apparent terminal elimination half-life (t1/2) of ZE66-0205
Time frame: Pre-dose through 168 hours post-dose
Terminal elimination rate constant (lambda z) of ZE66-0205
Time frame: Pre-dose through 168 hours post-dose
Total apparent body clearance after oral administration (CL/F) of ZE66-0205
Time frame: Pre-dose through 168 hours post-dose
Apparent volume of distribution after oral administration (Vz/F) of ZE66-0205
Time frame: Pre-dose through 168 hours post-dose
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 14 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Carlo Cervi contact
Ekaterina Dokukina study director
Eilean Therapeutics AU Pty Ltd
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 testing ZE66-0205 in people with Healthy Volunteers (HV), 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 8 inclusion and 21 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: opening soon, as of the sponsor's last update on 14 Aug 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. Some participants in this study may receive a placebo. 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, MD (+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 treatment-emergent adverse events (TEAEs) (time frame: From the first dose on Day 1 through the End-of-Study visit on Day 8 (±1 day)). The study lists 9 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 14 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.