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

PHASE1RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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) ≥ 18.5 and ≤ 32.0 kg/m2, with a body weight (to 1 decimal place) ≥ 50.0 kg at screening.

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

Exclusion criteria

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

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : Yes

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-07-28

Primary completion: 2024-10-01

Study completion finish: 2024-11-01

Study type

TREATMENT

Phase

PHASE1

Trial ID

NCT06399315

Intervention or treatment

DRUG: ZE46-0134 or placebo

DRUG: Rabeprazole, 20mg oral

Conditions

• AML

Condition: AML
DRUG: ZE46-0134 or placebo and other drugs
Perth, Nedlands, Australia
Sponsor: Eilean Therapeutics

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Linear Clinical Research Ltd

Research sites nearby

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Linear Clinical Research Ltd
Perth, Nedlands, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Level 1 Single dose Dose level 1. SAD study part. 6 participants will receive the study drug and 2 participants will receive placebo	DRUG: ZE46-0134 or placebo The patients will receive ZE46-0134 or placebo
EXPERIMENTAL: Level 2 Single dose Dose level 2. SAD study part. 6 participants will receive the study drug and 2 participants will receive placebo	DRUG: ZE46-0134 or placebo The patients will receive ZE46-0134 or placebo
EXPERIMENTAL: Level 3 Single dose Dose level 3. SAD study part. 6 participants will receive the study drug and 2 participants will receive placebo	DRUG: ZE46-0134 or placebo The patients will receive ZE46-0134 or placebo
EXPERIMENTAL: Level 3 Single dose after food Dose level 3 with a fat meal. SAD study part. 6 participants will receive the study drug and 2 participants will receive placebo	DRUG: ZE46-0134 or placebo The patients will receive ZE46-0134 or placebo
EXPERIMENTAL: Level 4 Single dose Dose level 4. SAD study part. 6 participants will receive the study drug and 2 participants will receive placebo	DRUG: ZE46-0134 or placebo The patients will receive ZE46-0134 or placebo
EXPERIMENTAL: Level 1 Multiple doses Dose level 1. MAD study part. 6 participants will receive the study drug and 2 participants will receive placebo	DRUG: ZE46-0134 or placebo The patients will receive ZE46-0134 or placebo
EXPERIMENTAL: Level 1 Multiple doses + rabeprazole 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	DRUG: ZE46-0134 or placebo The patients will receive ZE46-0134 or placebo
EXPERIMENTAL: Level 2 Multiple doses Dose level 2. MAD study part. 6 participants will receive the study drug and 2 participants will receive placebo	DRUG: ZE46-0134 or placebo The patients will receive ZE46-0134 or placebo

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Plasma concentration	Plasma concentration, ng/mL	72 hours for SAD, 10 days for MAD

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Incidence of AEs	Incidence of Adverse Events observed during the study	8 days in SAD part, 17 days for MAD part
Incidence of drug-related AEs	Incidence of Adverse Events observed during the study deemed related to the study drug by the Investigator	8 days in SAD part, 17 days for MAD part
Incidence of SAEs	Incidence of Serious Adverse Events observed during the study	8 days in SAD part, 17 days for MAD part
Incidence of lab deviations	Incidence of clinically relevant deviations in the clinical laboratory parameters	Time Frame: 8 days in SAD part, 17 days for MAD part

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

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References

Clinical Trials Gov: Study of Single and Multiple Ascending Doses of ZE46-0134 in Healthy Volunteers