Safety and Tolerability of ZE74-0282 in Healthy Volunteers (NCT07527221) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Safety and Tolerability of ZE74-0282 in Healthy Volunteers
Australia40 participantsStarted 2026-04-30
Plain-language summary
A first-in-human study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single doses under fasted and fed conditions of ZE74-0282 administered orally in healthy volunteers.
Who can participate
Age range18 Years – 55 Years
SexALL
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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.
✕. 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.
What they're measuring
1
Incidence of AEs/SAEs
Timeframe: up to Day 8
2
Change from Baseline in body weight
Timeframe: up to Day 8
3
Change from Baseline in blood pressure
Timeframe: up to Day 8
4
Change from Baseline in electrocardiogram (ECG) QT interval
Timeframe: up to Day 8
5
Change from Baseline in haematology parameters
Timeframe: Baseline to Day 8
6
Change from Baseline in pulse rate
Timeframe: up to Day 8
7
Change from Baseline in respiratory rate
Timeframe: up to Day 8
8
Change from Baseline in temperature
Timeframe: up to Day 8
9
Change from Baseline in clinical chemistry parameters