Study of Single and Multiple Ascending Doses of ZE46-0134 in Healthy Volunteers

Eilean Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: AML

Treatments: Drug: Rabeprazole, 20mg oral; Drug: ZE46-0134 or placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06399315

CT-2023-CTN-03208-1 (Other Identifier)

ZE46-0134-0001

Details and patient eligibility

About

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

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

  3. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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64 participants in 8 patient groups

Level 1 Single dose

Experimental group

Description:

Dose level 1. SAD study part. 6 participants will receive the study drug and 2 participants will receive placebo

Treatment:

Drug: ZE46-0134 or placebo

Level 2 Single dose

Experimental group

Description:

Dose level 2. SAD study part. 6 participants will receive the study drug and 2 participants will receive placebo

Treatment:

Drug: ZE46-0134 or placebo

Level 3 Single dose

Experimental group

Description:

Dose level 3. SAD study part. 6 participants will receive the study drug and 2 participants will receive placebo

Treatment:

Drug: ZE46-0134 or placebo

Level 3 Single dose after food

Experimental group

Description:

Dose level 3 with a fat meal. SAD study part. 6 participants will receive the study drug and 2 participants will receive placebo

Treatment:

Drug: ZE46-0134 or placebo

Level 4 Single dose

Experimental group

Description:

Dose level 4. SAD study part. 6 participants will receive the study drug and 2 participants will receive placebo

Treatment:

Drug: ZE46-0134 or placebo

Level 1 Multiple doses

Experimental group

Description:

Dose level 1. MAD study part. 6 participants will receive the study drug and 2 participants will receive placebo

Treatment:

Drug: ZE46-0134 or placebo

Level 1 Multiple doses + rabeprazole

Experimental group

Description:

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

Treatment:

Drug: Rabeprazole, 20mg oral

Drug: ZE46-0134 or placebo

Level 2 Multiple doses

Experimental group

Description:

Dose level 2. MAD study part. 6 participants will receive the study drug and 2 participants will receive placebo

Treatment:

Drug: ZE46-0134 or placebo