Clinical trial NCT06399315: Study of Single and Multiple Ascending Doses of ZE46-0134 in Healthy Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: AML
Lead sponsor: Eilean Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-05-03
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Plasma concentration
timeFrame: 72 hours for SAD, 10 days for MAD
Secondary outcomes:
measure: Incidence of AEs
timeFrame: 8 days in SAD part, 17 days for MAD part
measure: Incidence of drug-related AEs
timeFrame: 8 days in SAD part, 17 days for MAD part
measure: Incidence of SAEs
timeFrame: 8 days in SAD part, 17 days for MAD part
measure: Incidence of lab deviations
timeFrame: Time Frame: 8 days in SAD part, 17 days for MAD part
Other outcomes:
Locations:
city: Perth
country: Australia
facility: Linear Clinical Research Ltd
state: Nedlands
Study officials:
References: