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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06399315




Registration number
NCT06399315
Ethics application status
Date submitted
1/05/2024
Date registered
3/05/2024
Date last updated
3/05/2024

Titles & IDs
Public title
Study of Single and Multiple Ascending Doses of ZE46-0134 in Healthy Volunteers
Scientific 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
Secondary ID [1] 0 0
CT-2023-CTN-03208-1
Secondary ID [2] 0 0
ZE46-0134-0001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
AML 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ZE46-0134 or placebo
Treatment: Drugs - Rabeprazole, 20mg oral

Experimental: Level 1 Single dose - Dose level 1. SAD study part. 6 participants will receive the study drug and 2 participants will receive 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

Experimental: Level 3 Single dose - Dose level 3. SAD study part. 6 participants will receive the study drug and 2 participants will receive 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

Experimental: Level 4 Single dose - Dose level 4. SAD study part. 6 participants will receive the study drug and 2 participants will receive 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

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

Experimental: Level 2 Multiple doses - Dose level 2. MAD study part. 6 participants will receive the study drug and 2 participants will receive placebo


Treatment: Drugs: ZE46-0134 or placebo
The patients will receive ZE46-0134 or placebo

Treatment: Drugs: Rabeprazole, 20mg oral
Rabeprazole 20 mg daily will be administered for 2 prior ZE46-0134 and 7 co-administered
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Plasma concentration
Timepoint [1] 0 0
72 hours for SAD, 10 days for MAD
Secondary outcome [1] 0 0
Incidence of AEs
Timepoint [1] 0 0
8 days in SAD part, 17 days for MAD part
Secondary outcome [2] 0 0
Incidence of drug-related AEs
Timepoint [2] 0 0
8 days in SAD part, 17 days for MAD part
Secondary outcome [3] 0 0
Incidence of SAEs
Timepoint [3] 0 0
8 days in SAD part, 17 days for MAD part
Secondary outcome [4] 0 0
Incidence of lab deviations
Timepoint [4] 0 0
Time Frame: 8 days in SAD part, 17 days for MAD part

Eligibility
Key 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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2024
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Nedland
Recruitment hospital [1] 0 0
Linear Clinical Research Ltd - Perth
Recruitment postcode(s) [1] 0 0
WA 6009 - Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eilean Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT06399315
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ekaterina Dokukina, MD, Mphil
Address 0 0
Country 0 0
Phone 0 0
069728309
Fax 0 0
Email 0 0
kdokukina@eileanther.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06399315