Testing ZE46-0134 in healthy volunteers for safety and effectiveness

A Randomised, Double-Blind, Placebo-Controlled, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of ZE46-0134 in Healthy Volunteers

This study is testing a new drug called ZE46-0134 in healthy volunteers to see if it's safe and how well it works.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Eilean Therapeutics (Industry-sponsored)
• Locations: 1 site (Perth, Nedlands)
• Trial ID: NCT06399315 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the pharmacokinetics and biomarker evidence of ZE46-0134 in healthy volunteers through a Phase 1, double-blind, placebo-controlled, dose escalation approach. The study consists of two parts: a single ascending dose (SAD) and a multiple ascending dose (MAD), with participants receiving either the study drug or a placebo. The aim is to assess the safety, tolerability, and pharmacodynamics of ZE46-0134, including the effects of food and co-administration with rabeprazole. Participants will be closely monitored for any adverse effects throughout the dosing periods.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 to 55 with a BMI between 18.5 and 32.0 kg/m2.

Not a fit: Patients with significant underlying health conditions or recent acute illnesses may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the safety and efficacy of ZE46-0134, potentially leading to new treatment options for conditions like AML.

How similar studies have performed: Other studies involving similar dose escalation and pharmacokinetic assessments have shown promise, but this specific approach with ZE46-0134 is novel.

Eligibility criteria

Inclusion Criteria:

* 1. 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.

  2. Adult males and females, 18 to 55 years of age (inclusive) at screening. 3. Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2, with a body weight (to 1 decimal place) ≥ 50.0 kg at screening.

  4. Medically healthy without clinically significant abnormalities (in the opinion of the Investigator) at the screening visit and prior to dosing

Exclusion Criteria:

1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, 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.
2. Acute infections within 4 weeks prior to screening or current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications.
3. 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.
4. Any history of malignant disease in the last 5 years (excludes surgically resected skin squamous cell or basal cell carcinoma).
5. Any screening laboratory result outside the normal laboratory reference range (as confirmed upon repeated testing) and deemed clinically significant by the PI.
6. Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia

Where this trial is running

Perth, Nedlands

• Linear Clinical Research Ltd — Perth, Nedlands, Australia (Recruiting)

Study contacts

• Study coordinator: Ekaterina Dokukina, MD, Mphil

Conditions AML