A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AK0406 Injection in Healthy Adult Participants

Starting soon · Phase 1 · Has a placebo group

Conditions studied: Healthy Participants

In brief

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.

Key facts

Study ID

NCT07432698

Run by

Shanghai Ark Biopharmaceutical Co., Ltd.

People needed

32

Starts

2026-02-01

Expected to finish

2027-04-01

Last updated by the study team

2026-02-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• Veritus Research — Bayswater, Victoria, Australia

Full record on ClinicalTrials.gov

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