A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AK0406 Injection in Healthy Adult Participants
Sponsored by Shanghai Ark Biopharmaceutical Co., Ltd.
About this trial
Last updated 3 months ago
Study ID
AK0406-1001
Status
Not yet recruiting
Type
Interventional
Phase
Phase 1
Placebo
No
Accepting
18 to 65 Years
All Sexes
Trial Timing
Started 4 months ago
What is this trial about?
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.
What are the participation requirements?
Inclusion Criteria
* 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.
* Participants must voluntarily agree to participate, be able to communicate effectively with the investigator, understand and comply with study requirements, and provide written informed consent.
Exclusion Criteria
* 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.
* Major surgery within 3 months before screening or planned major surgery within 6 months after study drug administration.
* Known hypersensitivity to neuraminidase inhibitors (e.g., oseltamivir, zanamivir, peramivir), or to AK0406 active ingredient or any excipients.
* Anaphylaxis or severe hypersensitivity (e.g., hypotension, dyspnea, severe angioedema).
Diagnostic Assessments
* Positive for Human immunodeficiency virus (HIV) antibody, Hepatitis C virus (HCV) antibody, Hepatitis B surface antigen (HBsAg), or Treponema pallidum antibody.
* Systolic blood pressure >140 millimeters of mercury (mmHg) or ≤90 mmHg, diastolic blood pressure ≥90 mmHg or ≤50 mmHg, or pulse ≤45 or ≥110 beats per minute (bpm) while awake and at rest.
* The Corrected QT interval by Fredericia (QTcF) prolongation (up to 450 ms in males / 470 milliseconds (ms) in females) at screening. [QTcF = QT/(RR^0.33)] (RR = 60/heart rate)