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

A Phase I, Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profiles of AK0406 in Healthy Adult Participants

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: AK0406 150 mg; Drug: AK0406 300 mg; Drug: AK0406 600 mg; Drug: AK0406 900 mg; Drug: 0.9% Sodium Chloride Injection as Placebo

Detailed Description

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
• Enrollment (Estimated): 32
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Nora Guo; Phone Number: 86-21-50681677; Email: nora.guo@arkbiosciences.com

Study Locations

• Australia
  • Victoria
    • Bayswater, Victoria, Australia, 3153
      • Veritus Research
      • Contact: Principal Investigator; Phone Number: 86-21-50681677; Email: nora.guo@arkbiosciences.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: 0.9% Sodium Chloride Injection as Placebo; 0.9% Sodium Chloride Injection, subcutaneous injection
Experimental: Cohort A: AK0406 150 mg	Drug: AK0406 150 mg; Single dose of AK0406 150 mg，subcutaneous injection
Experimental: Cohort B：AK0406 300 mg	Drug: AK0406 300 mg; Single dose of AK0406 300 mg，subcutaneous injection
Experimental: Cohort C：AK0406 600 mg	Drug: AK0406 600 mg; Single dose of AK0406 600 mg，subcutaneous injection
Experimental: Cohort D：AK0406 900 mg	Drug: AK0406 900 mg; Single dose of AK0406 900 mg，subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to Day 181

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum concentration	Samples will be used to evaluate maximum concentration of AK0406 and zanamivir (if any) in plasma.	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.	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.	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.	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.	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.	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.	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.	Baseline, Day 15, Day 31, Day 91, Day 181

Collaborators and Investigators

• Sponsor: Shanghai Ark Biopharmaceutical Co., Ltd.
• Collaborators: Ark Biosciences Pty Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: February 14, 2026
• First Submitted That Met QC Criteria: February 24, 2026
• First Posted (Actual): February 25, 2026

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Safety; Pharmacokinetics; Tolerability
• Additional Relevant MeSH Terms: Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Sodium Chloride
• Other Study ID Numbers: AK0406-1001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No