Study of Single and Multiple Ascending Doses of ZE46-0134 in Healthy Volunteers
- Conditions
- AML
- Interventions
- Drug: ZE46-0134 or placeboDrug: Rabeprazole, 20mg oral
- Registration Number
- NCT06399315
- Lead Sponsor
- Eilean Therapeutics
- Brief Summary
This is a clinical study aiming to assess pharmacokinetics and biomarker evidence of ZE46-0134 efficacy in Healthy Volunteers after single and multiple daily doses of the study drug
- Detailed Description
This is a Phase 1, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, PK, PD of orally administered ZE46-0134 in Healthy Volunteers. The study will be conducted in 2 parts: a single ascending dose (SAD) part at up to 5 dose levels and a multiple ascending dose (MAD) part at up to 3 dose levels. Evaluation of dose levels will be conducted in a sequential fashion with lower dose levels evaluated first in the sequence. Dosing in each cohort will start with two sentinel participants with one of the two sentinels randomised to receive ZE46-0134 and the other randomised to receive placebo. The food-effect will be investigated in SAD part and safety/PK of co-administration with rabeprazole will be investigated in MAD part.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 64
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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.
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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.
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Medically healthy without clinically significant abnormalities (in the opinion of the Investigator) at the screening visit and prior to dosing
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- 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.
- Acute infections within 4 weeks prior to screening 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Level 1 Single dose ZE46-0134 or placebo Dose level 1. SAD study part. 6 participants will receive the study drug and 2 participants will receive placebo Level 1 Multiple doses + rabeprazole Rabeprazole, 20mg oral Dose level 2. MAD study part. 6 participants will receive the study drug and 2 participants will receive placebo. The drug is co-administered with rabeprazole Level 2 Multiple doses ZE46-0134 or placebo Dose level 2. MAD study part. 6 participants will receive the study drug and 2 participants will receive placebo Level 2 Single dose ZE46-0134 or placebo Dose level 2. SAD study part. 6 participants will receive the study drug and 2 participants will receive placebo Level 3 Single dose ZE46-0134 or placebo Dose level 3. SAD study part. 6 participants will receive the study drug and 2 participants will receive placebo Level 3 Single dose after food ZE46-0134 or placebo Dose level 3 with a fat meal. SAD study part. 6 participants will receive the study drug and 2 participants will receive placebo Level 4 Single dose ZE46-0134 or placebo Dose level 4. SAD study part. 6 participants will receive the study drug and 2 participants will receive placebo Level 1 Multiple doses ZE46-0134 or placebo Dose level 1. MAD study part. 6 participants will receive the study drug and 2 participants will receive placebo Level 1 Multiple doses + rabeprazole ZE46-0134 or placebo Dose level 2. MAD study part. 6 participants will receive the study drug and 2 participants will receive placebo. The drug is co-administered with rabeprazole
- Primary Outcome Measures
Name Time Method Plasma concentration 72 hours for SAD, 10 days for MAD Plasma concentration, ng/mL
- Secondary Outcome Measures
Name Time Method Incidence of drug-related AEs 8 days in SAD part, 17 days for MAD part Incidence of Adverse Events observed during the study deemed related to the study drug by the Investigator
Incidence of AEs 8 days in SAD part, 17 days for MAD part Incidence of Adverse Events observed during the study
Incidence of SAEs 8 days in SAD part, 17 days for MAD part Incidence of Serious Adverse Events observed during the study
Incidence of lab deviations Time Frame: 8 days in SAD part, 17 days for MAD part Incidence of clinically relevant deviations in the clinical laboratory parameters
Trial Locations
- Locations (1)
Linear Clinical Research Ltd
🇦🇺Perth, Nedlands, Australia