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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
112
The patients will receive ZE46-0134 or placebo
Rabeprazole 20 mg daily will be administered for 2 prior ZE46-0134 and 7 co-administered
Itraconazole 200 mg BID
Linear Clinical Research Ltd
Perth, Nedlands, Australia
Plasma concentration
Plasma concentration, ng/mL
Time frame: 72 hours for SAD, 10 days for MAD
Incidence of AEs
Incidence of Adverse Events observed during the study
Time frame: 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
Time frame: 8 days in SAD part, 17 days for MAD part
Incidence of SAEs
Incidence of Serious Adverse Events observed during the study
Time frame: 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: Time Frame: 8 days in SAD part, 17 days for MAD part
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