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

AML Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06399315
• Other study ID #: ZE46-0134-0001
• Secondary ID: CT-2023-CTN-0320
• Status: Recruiting
• Phase: Phase 1
• Start date: July 28, 2023
• Est. completion date: November 2024

Study information

• Verified date: April 2024
• Source: Eilean Therapeutics
• Contact: Ekaterina Dokukina, MD, Mphil
• Phone: 069728309
• Email: kdokukina[@]eileanther.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: November 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• AML

Intervention

Drug:
• ZE46-0134 or placebo
The patients will receive ZE46-0134 or placebo
• Rabeprazole, 20mg oral
Rabeprazole 20 mg daily will be administered for 2 prior ZE46-0134 and 7 co-administered

Locations

Country	Name	City	State
Australia	Linear Clinical Research Ltd	Perth	Nedlands

Sponsors (1)

Lead Sponsor	Collaborator
Eilean Therapeutics

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentration	Plasma concentration, ng/mL	72 hours for SAD, 10 days for MAD
Secondary	Incidence of AEs	Incidence of Adverse Events observed during the study	8 days in SAD part, 17 days for MAD part
Secondary	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
Secondary	Incidence of SAEs	Incidence of Serious Adverse Events observed during the study	8 days in SAD part, 17 days for MAD part
Secondary	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