Clinical Study Aiming to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics… (NCT06787131) | Clinical Trial Compass
CompletedPhase 1
Clinical Study Aiming to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Administration of ZE50-0134 at 5 Dose Levels in Healthy Volunteers
Australia104 participantsStarted 2024-05-21
Plain-language summary
A first-in-human study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of ZE50-0134 administered orally in healthy volunteers.
Who can participate
Age range18 Years – 55 Years
SexALL
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 (to 1 decimal place) ≥ 50.0 kg (males) or 45.0 kg (females) at screening.
✓. Medically healthy without clinically significant abnormalities (in the opinion of the Investigator) at the screening visit and prior to dosing at the timepoints indicated in the Schedule of Assessments, including:
✓. Physical examination without any clinically significant findings.
✓. Systolic blood pressure in the range of 90 mm Hg to 160 mm Hg; diastolic blood pressure in the range of 40 mm Hg to 95 mm Hg.
✓. Heart rate (HR) in the range of 40 to 100 bpm after 5 minutes in a supine or semi-supine position
✓. Body temperature (tympanic or oral) in the range 35.5°C to 37.7°C (inclusive).
Exclusion criteria
✕. History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or major surgery within the past 3 months determined by the PI to be clinically significant. Note: participants with a history of fully resolved childhood asthma are permitted.
What they're measuring
1
Plasma pharmacokinetics of ZE50-0134
Timeframe: Within 15 min prior to dosing with ZE50-0134/placebo to 168 hours post-dose
2
Plasma pharmacokinetics of ZE50-0134 with and without rabeprazole (PPI)
Timeframe: Within 60 min prior to dosing with ZE50-0134/placebo to 168 hours post-dose
. Acute infections within 4 weeks prior to Day -1 (nominal Cohorts 1-10) or Day -4 (nominal Cohort 11), or current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications.
✕. Presence or history of any abnormality or illness, including gastrointestinal surgery, which in the opinion of the PI may affect absorption, distribution, metabolism or elimination of the study drug. Note: participants with Gilbert's syndrome may be permitted, at the discretion of the PI (or delegate). Participants with a history of cholecystectomy may be permitted at the discretion of the PI (or delegate).
✕. Any history of malignant disease in the last 5 years (excludes surgically resected skin squamous cell or basal cell carcinoma)
✕. Any screening laboratory result outside the normal laboratory reference range (as confirmed upon repeated testing) and deemed clinically significant by the PI.
✕. Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia.
✕. Use of or plans to use systemic immunosuppressive (e.g., corticosteroids by any route, methotrexate, azathioprine, cyclosporine) or immunomodulating medications (e.g., interferon) during the study or within 5 half-lives of individual agent or within 28 days (whichever is longer) prior to first study drug administration.
✕. Use of or plans to use agents (e.g., grapefruit and grapefruit products) that have clinically significant interaction with CYP3A4 or the use of any medications that could have a significantly impact on organ function (e.g., barbiturates, omeprazole, cimetidine) during the study or within 5 half-lives of individual agent or within 28 days (whichever is longer) prior to first study drug administration. Note: timeframe = 3 days for grapefruit and grapefruit products or other foods/drinks (e.g. pomelo) that may have a clinically significant interaction with CYP3A4.