Not yet recruitingNCT07432698Updated Feb 25, 2026

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

A Phase 1 interventional study of AK0406 150 mg and AK0406 300 mg in Healthy Participants, sponsored by Shanghai Ark Biopharmaceutical Co., Ltd.. Not yet recruiting at 1 site in Australia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-25.

Sponsored by Shanghai Ark Biopharmaceutical Co., Ltd. · Phase 1, Interventional, and Prevention

Phase: Phase 1
Study type: Interventional
Enrollment: 32
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Healthy Participants

Keywords

Pharmacokinetics
Safety
Tolerability

In context

Lead sponsor

Shanghai Ark Biopharmaceutical Co., Ltd. is the lead sponsor of 20 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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 design

Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 32 participants (estimated)

Study arms

Experimental
Cohort A: AK0406 150 mg
Drug: AK0406 150 mg
Experimental
Cohort B：AK0406 300 mg
Drug: AK0406 300 mg
Experimental
Cohort C：AK0406 600 mg
Drug: AK0406 600 mg
Experimental
Cohort D：AK0406 900 mg
Drug: AK0406 900 mg
Placebo comparator
Placebo
Drug: 0.9% Sodium Chloride Injection as Placebo

Interventions

DrugAK0406 150 mg
Single dose of AK0406 150 mg，subcutaneous injection
DrugAK0406 300 mg
Single dose of AK0406 300 mg，subcutaneous injection
DrugAK0406 600 mg
Single dose of AK0406 600 mg，subcutaneous injection
DrugAK0406 900 mg
Single dose of AK0406 900 mg，subcutaneous injection
Drug0.9% Sodium Chloride Injection as Placebo
0.9% Sodium Chloride Injection, subcutaneous injection

What researchers measure

Primary outcomes

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.
Time frame: Up to Day 181

Secondary outcomes

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

Study locations

1 site

Veritus Research
Bayswater, Victoria 3153, Australia
- Principal Investigator · Contact · nora.guo@arkbiosciences.com · 86-21-50681677

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07432698
Lead sponsor: Shanghai Ark Biopharmaceutical Co., Ltd.
Collaborators: Ark Biosciences Pty Ltd.
Responsible party: Sponsor
First posted: Feb 25, 2026
Start date: Feb 2026 (estimated)
Primary completion: Apr 2027 (estimated)
Completion: Apr 2027 (estimated)
Last update: Feb 25, 2026

Study contacts

Nora Guo

Contact

nora.guo@arkbiosciences.com

86-21-50681677

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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