AML
Conditions
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 6 dose levels and a multiple ascending dose (MAD) part at up to 5 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.
Interventions
DRUGZE46-0134 or placebo
The patients will receive ZE46-0134 or placebo
DRUGRabeprazole, 20mg oral
Rabeprazole 20 mg daily will be administered for 2 prior ZE46-0134 and 7 co-administered
Itraconazole 200 mg BID
Sponsors
Lomond Therapeutics Holdings, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-Blind, Placebo-Controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentration | 72 hours for SAD, 10 days for MAD | Plasma concentration, ng/mL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of AEs | 8 days in SAD part, 17 days for MAD part | Incidence of Adverse Events observed during the study |
| Incidence of drug-related AEs | 8 days in SAD part, 17 days for MAD part | Incidence of Adverse Events observed during the study deemed related to the study drug by the Investigator |
| Incidence of SAEs | 8 days in SAD part, 17 days for MAD part | Incidence of Serious Adverse Events observed during the study |
| Incidence of lab deviations | Time Frame: 8 days in SAD part, 17 days for MAD part | Incidence of clinically relevant deviations in the clinical laboratory parameters |
Countries
Australia
Outcome results
None listed