Safety and Tolerability of ZE74-0282 in Healthy Volunteers (NCT07527221) | Clinical Trial Compass
RecruitingPhase 1
Safety and Tolerability of ZE74-0282 in Healthy Volunteers
Australia64 participantsStarted 2026-04-16
Plain-language 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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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;
. 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.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of AEs/SAEs
Timeframe: Baseline to Day 8
2
Change from Baseline in body weight
Timeframe: Baseline to Day 8
3
Change from Baseline in blood pressure
Timeframe: Baseline to Day 8
4
Change from Baseline in electrocardiogram (ECG) QT interval
. 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.
. 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.
Timeframe: Baseline to Day 8
9
Change from Baseline in clinical chemistry parameters