A First-in-Human Study of ZE66-0205 in Healthy Volunteers
ConditionHealthy Volunteers (HV)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorEilean Therapeutics
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
ZE66-0205
DrugZE66-0205 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
DrugPlacebo formulation not containing the active drug
Treatment groups
32 Participants
are divided into 5 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: Experimental: Cohort 1Experimental treatment 1 intervention
Group C: Experimental: Cohort 2Experimental treatment 1 intervention
Group D: Experimental: Cohort 3Experimental treatment 1 intervention
Group E: Experimental: Cohort 4Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)2
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)3
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)4
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)Secondary outcomes
1
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-dose2
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-dose3
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-dose4
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-doseOther outcomes
1
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-dose2
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-doseSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: