This is a single-center, randomized, double-blind, placebo-controlled, first-in-human study in which the safety, tolerability, and pharmacokinetics of orally administered AP303 will be assessed in healthy adult subjects.
The study will consist of 2 parts: Part A is a single ascending doses (SAD) phase enrolling a total of 4 cohorts of healthy subjects; Part B is a multiple ascending doses (MAD) phase enrolling 3 cohorts of healthy subjects. One cohort of Part A will receive AP303 under both fasted and fed conditions to investigate the effect of food.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
62
Nucleus Network Pty Ltd
Melbourne, Victoria, Australia
Single Dose and Food Effect Safety Outcome Measures
Incidence and severity of adverse events (AEs), laboratory, ECG, and vital sign changes
Time frame: From baseline to Day 14 (Day 29 for Food Effect)
Multiple Dose Safety Outcome Measures
Incidence and severity of AEs, laboratory, ECG, and vital sign changes.
Time frame: From baseline to Day 28
Cmax after single dose
PK characteristics after single dose
Time frame: Pre-dose to 96 hours post-dose
Tmax after single dose
PK characteristics after single dose
Time frame: Pre-dose to 96 hours post-dose
AUC0-last after single dose
PK characteristics after single dose
Time frame: Pre-dose to 96 hours post-dose
AUC0-inf after single dose
PK characteristics after single dose
Time frame: Pre-dose to 96 hours post-dose
t1/2 after single dose
PK characteristics after single dose
Time frame: Pre-dose to 96 hours post-dose
CL/F after single dose
PK characteristics after single dose
Time frame: Pre-dose to 96 hours post-dose
Ae and CLR (if warranted) after single dose
PK characteristics after single dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
AP303 tablet
Placebo tablet
Placebo tablet
Placebo tablet
Placebo tablet
Time frame: Pre-dose to 96 hours post-dose
V/F after single dose
PK characteristics after single dose
Time frame: Pre-dose to 96 hours post-dose
Cmax after multiple dose
PK characteristics after multiple dose
Time frame: Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
Tmax after multiple dose
PK characteristics after multiple dose
Time frame: Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
AUC0-τ after multiple dose
PK characteristics after multiple dose
Time frame: Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
Cav after multiple dose
PK characteristics after multiple dose
Time frame: Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
t1/2 after multiple dose
PK characteristics after multiple dose
Time frame: Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
Rac after multiple dose
PK characteristics after multiple dose
Time frame: Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
Ae and CLR (if warranted) after multiple dose
PK characteristics after multiple dose
Time frame: Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
V/F after multiple dose
PK characteristics after multiple dose
Time frame: Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
Ctrough after multiple dose
PK characteristics after multiple dose
Time frame: Pre-dose on Days 2, 3, 4, 5, 7, 12, and 13
Effect of Food on the single dose Cmax
Effect of food on the single dose PK
Time frame: Pre-dose to 96 hours post-dose
Effect of Food on the single dose Tmax
Effect of food on the single dose PK
Time frame: Pre-dose to 96 hours post-dose
Effect of Food on the single dose AUC0-last
Effect of food on the single dose PK
Time frame: Pre-dose to 96 hours post-dose
Effect of Food on the single dose AUC0-inf
Effect of food on the single dose PK
Time frame: Pre-dose to 96 hours post-dose
Effect of Food on the single dose t1/2
Effect of food on the single dose PK
Time frame: Pre-dose to 96 hours post-dose
Effect of Food on the single dose CL/F
Effect of food on the single dose PK
Time frame: Pre-dose to 96 hours post-dose
Effect of Food on the single dose Ae and CLR (if warranted)
Effect of food on the single dose PK
Time frame: Pre-dose to 96 hours post-dose
Effect of Food on the single dose V/F
Effect of food on the single dose PK
Time frame: Pre-dose to 96 hours post-dose