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.
Male or female participants aged 18 to 65 years (inclusive) at the time of formed consent.
At screening, male participants must weigh ≥50 kilogram (kg), and female participants must weigh ≥45 kg, with a body mass index between 18.0 and 32.0 kilograms per square meter (kg/m²) (inclusive).
Participants must be in good general health as determined by the investigator, with no clinically significant abnormalities in vital signs, 12-lead electrocardiogram (ECG), or laboratory tests.
Woman of childbearing potential (WOCBP) and male participants whose female sexual partner is WOCBP must agree to use highly effective contraception from the day of study drug administration until 6 months after dosing and must agree to avoid sperm or oocyte donation and not plan to conceive during this period.
Presence of clinically significant cardiovascular, respiratory, hepatic, renal, hematologic (e.g., bleeding disorders), gastrointestinal, endocrine, immune, dermatologic, neurologic, or psychiatric disease, or any other condition that, in the opinion of the investigator, may compromise participant safety, interfere with study results, or prevent completion of the study.
Active malignancy or history of malignancy (except adequately treated basal cell carcinoma with no evidence of recurrence).
History of congenital or acquired immunodeficiency.
Acute illness (e.g., fever, infectious disease, diarrhea) within 7 days prior to first dosing.
Parallel
AK0406 150 mg
DrugSingle dose of AK0406 150 mg，subcutaneous injection
AK0406 300 mg
DrugSingle dose of AK0406 300 mg，subcutaneous injection
AK0406 600 mg
DrugSingle dose of AK0406 600 mg，subcutaneous injection
AK0406 900 mg
DrugSingle dose of AK0406 900 mg，subcutaneous injection
0.9% Sodium Chloride Injection as Placebo
Drug0.9% Sodium Chloride Injection, subcutaneous injection
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.
Maximum concentration
Samples will be used to evaluate maximum concentration of AK0406 and zanamivir (if any) in plasma.
Time to maximum concentration
Samples will be used to evaluate time to maximum concentration of AK0406 and zanamivir (if any) in plasma.
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.
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.
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Shanghai Ark Biopharmaceutical Co., Ltd.
Lead sponsor
Ark Biosciences Pty Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
