This study is a phase I, single-center, randomized, double-blind, placebo-controlled study of AK0406 as a first-in-human (FIH) trial to evaluate the safety, tolerability and pharmacokinetics (PK) of AK0406 in healthy adult participants.
This study consists of four cohorts: Cohort A: 150 milligram (mg) subcutaneous injection (s.c.) Cohort B: 300 mg s.c. Cohort C: 600 mg s.c. Cohort D: 900 mg s.c. Each cohort will enroll 8 healthy adult participants (AK0406: placebo = 3: 1), including both females and males. Dose escalation will follow a sequential order, beginning with the lowest dose 150 mg and proceeding to 300 mg, 600 mg, and finally 900 mg. A sentinel-dosing strategy will be implemented. For the first cohort (Cohort A) and the last cohort (Cohort D): the first two participants (1 AK0406, 1 placebo) will be dosed and observed for at least 7 days. The first two participants (1 AK0406, 1 placebo) in Cohort B and Cohort C will be dosed and observed for over 48 hours. After both the investigator and sponsor agree with the acceptable safety and tolerability profile, the remaining 6 participants (5 AK0406, 1 placebo) in that cohort will be dosed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
32
Single dose of AK0406 150 mg,subcutaneous injection
Single dose of AK0406 300 mg,subcutaneous injection
Single dose of AK0406 600 mg,subcutaneous injection
Veritus Research
Bayswater, Victoria, Australia
Adverse events
Capture the incidence and severity of adverse events using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 6.0 throughout the study period.
Time frame: Up to Day 181
Maximum concentration
Samples will be used to evaluate maximum concentration of AK0406 and zanamivir (if any) in plasma.
Time frame: Pre-dose, Day 1, Day 3, Day 5, Day 7, Day 15, Day 22, Day 31, Day 61, Day 91, Day 121, Day 151, Day 181
Time to maximum concentration
Samples will be used to evaluate time to maximum concentration of AK0406 and zanamivir (if any) in plasma.
Time frame: Pre-dose, Day 1, Day 3, Day 5, Day 7, Day 15, Day 22, Day 31, Day 61, Day 91, Day 121, Day 151, Day 181
Area under the drug concentration-time curve from time 0 to the last measurable concentration
Samples will be used to evaluate area under the drug concentration-time curve from time 0 to the last measurable concentration of AK0406 and zanamivir (if any) in plasma.
Time frame: Pre-dose, Day 1, Day 3, Day 5, Day 7, Day 15, Day 22, Day 31, Day 61, Day 91, Day 121, Day 151, Day 181
Area under the drug concentration-time curve from time 0 to extrapolated to infinite time
Samples will be used to evaluate area under the drug concentration-time curve from time 0 to extrapolated to infinite time of AK0406 and zanamivir (if any) in plasma.
Time frame: Pre-dose, Day 1, Day 3, Day 5, Day 7, Day 15, Day 22, Day 31, Day 61, Day 91, Day 121, Day 151, Day 181
Terminal half-life
Samples will be used to evaluate terminal half-life of AK0406 and zanamivir (if any) in plasma.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Single dose of AK0406 900 mg,subcutaneous injection
0.9% Sodium Chloride Injection, subcutaneous injection
Time frame: Pre-dose, Day 1, Day 3, Day 5, Day 7, Day 15, Day 22, Day 31, Day 61, Day 91, Day 121, Day 151, Day 181
Apparent clearance
Samples will be used to evaluate apparent clearance of AK0406 and zanamivir (if any) in plasma.
Time frame: Pre-dose, Day 1, Day 3, Day 5, Day 7, Day 15, Day 22, Day 31, Day 61, Day 91, Day 121, Day 151, Day 181
Apparent volume of distribution
Samples will be used to evaluate apparent volume of distribution of AK0406 and zanamivir (if any) in plasma.
Time frame: Pre-dose, Day 1, Day 3, Day 5, Day 7, Day 15, Day 22, Day 31, Day 61, Day 91, Day 121, Day 151, Day 181
Incidence and titer of anti-drug antibodies
Incidence and titer of anti-drug antibodies against AK0406 detected in serum.
Time frame: Baseline, Day 15, Day 31, Day 91, Day 181