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

NCT07432698 | Not Yet Recruiting Phase 1

• 1 other identifier: AK0406-1001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Participants

Keywords

Pharmacokinetics; Safety; Tolerability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Maximum concentration

  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

  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

  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

  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

  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

Study Arms (5)

Cohort A: AK0406 150 mg

EXPERIMENTAL

Drug: AK0406 150 mg

Cohort B：AK0406 300 mg

EXPERIMENTAL

Drug: AK0406 300 mg

Cohort C：AK0406 600 mg

EXPERIMENTAL

Drug: AK0406 600 mg

Cohort D：AK0406 900 mg

EXPERIMENTAL

Drug: AK0406 900 mg

Placebo

PLACEBO COMPARATOR

Drug: 0.9% Sodium Chloride Injection as Placebo

Interventions

AK0406 150 mg DRUG

Single dose of AK0406 150 mg，subcutaneous injection

Cohort A: AK0406 150 mg

AK0406 300 mg DRUG

Single dose of AK0406 300 mg，subcutaneous injection

Cohort B：AK0406 300 mg

AK0406 600 mg DRUG

Single dose of AK0406 600 mg，subcutaneous injection

Cohort C：AK0406 600 mg

AK0406 900 mg DRUG

Single dose of AK0406 900 mg，subcutaneous injection

Cohort D：AK0406 900 mg

0.9% Sodium Chloride Injection as Placebo DRUG

0.9% Sodium Chloride Injection, subcutaneous injection

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Shanghai Ark Biopharmaceutical Co., Ltd.: lead
• Ark Biosciences Pty Ltd.: collaborator

Study Sites (1)

Veritus Research

Bayswater, Victoria, 3153, Australia

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Nora Guo

CONTACT

86-21-50681677; nora.guo@arkbiosciences.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 14, 2026
• First Posted: February 25, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)