This is a FIH, randomized, double- blind, placebo-controlled, dose -escalation study to investigate the safety, tolerability, PK, and PD of ENN0403 after single and multiple oral dose administration in healthy adult subjects. The study will include 2 parts which will proceed in a parallel staggered manner: Part A, a single ascending dose (SAD) study and Part B, a multiple ascending dose (MAD) study. Approximately 80 healthy adult subjects will be enrolled at a single site in Australia, in up to 6 cohorts in Part A (SAD study), including a Food Effect (FE) study, and up to 4 cohorts in Part B (MAD study). Part A is for the single dose use of IP, while Part B is once daily use for 14 consecutive days. Each cohort will include 8 subjects (6 receiving ENN0403 and 2 receiving placebo). Each subject will be enrolled in only 1 cohort and receive only one dose regimen in this study. Dosing will be escalated in a sequential fashion, contingent on a review of safety, tolerability, and available PK data of the previous dose level by a Safety Review Committee (SRC). The proposed dose levels/ dosing frequency of ENN0403 may be adjusted over the course of the whole study and cohorts may be added or removed depending on the emerging safety, tolerability, and available PK data.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
69
ENN0403 capsules for oral use
ENN0403 capsules for oral use
ENN0403 capsules for oral use
ENN0403 capsules for oral use
ENN0403 capsules for oral use
ENN0403 capsules for oral use
ENN0403 capsules for oral use
ENN0403 capsules for oral use
ENN0403 capsules for oral use
Placebo capsules for oral use
CMAX Clinical Research Pty Ltd
Adelaide, Adelaide, Australia
Number of participants with treatment emergent adverse events (TEAE) following ENN0403 administration
Time frame: From first dose of ENN0403 administration till 7 days after last dose of ENN0403 administration.
Maximum Plasma Concentration [Cmax]
Cmax is the maximum measured concentration of ENN0403 in plasma after oral administration
Time frame: Single Ascending Dose (SAD) part: up to Day 4, 72 hours post dose; Multiple Ascending Dose (MAD) part: up to Day 17, 72 hours post last dose
Area Under the Curve [AUC]
AUC is the area under the concentration-time curve of ENN0403 in plasma after oral administration
Time frame: Single Ascending Dose (SAD) part: up to Day 4, 72 hours post dose; Multiple Ascending Dose (MAD) part: up to Day 17, 72 hours post last dose
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