Healthy ParticipantsPhase 1NCT07432698

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

A Phase 1 study testing AK0406 150 mg, AK0406 300 mg and AK0406 600 mg in people with Healthy Participants, run by Shanghai Ark Biopharmaceutical Co., Ltd. at 1 site in Australia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial 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 more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Participants
What is being tested?: AK0406 150 mg, AK0406 300 mg and AK0406 600 mg
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 32 participants
Where: 1 siteAustralia
Study dates: 27 Apr 2026to Apr 2027
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 11Show fewer

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)

Trial locations and contacts

1 site in 1 country.

Australia1 site

Veritus Research
Bayswater, Victoria, 3153

Other trials in Australia

About this study

Official title: 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

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: Healthy Participants
Being tested: AK0406 150 mg, AK0406 300 mg, AK0406 600 mg, AK0406 900 mg, 0.9% Sodium Chloride Injection as Placebo
Keywords: Pharmacokinetics, Safety, Tolerability

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AK0406 150 mgDrug
Single dose of AK0406 150 mg，subcutaneous injection
AK0406 300 mgDrug
Single dose of AK0406 300 mg，subcutaneous injection
AK0406 600 mgDrug
Single dose of AK0406 600 mg，subcutaneous injection
AK0406 900 mgDrug
Single dose of AK0406 900 mg，subcutaneous injection
0.9% Sodium Chloride Injection as PlaceboDrug
0.9% Sodium Chloride Injection, subcutaneous injection

Study groups in NCT07432698
Study group	Role	What they receive
Cohort A: AK0406 150 mg	Experimental	Not described Receives: Drug: AK0406 150 mg
Cohort B：AK0406 300 mg	Experimental	Not described Receives: Drug: AK0406 300 mg
Cohort C：AK0406 600 mg	Experimental	Not described Receives: Drug: AK0406 600 mg
Cohort D：AK0406 900 mg	Experimental	Not described Receives: Drug: AK0406 900 mg
Placebo	Placebo comparator	Not described Receives: Drug: 0.9% Sodium Chloride Injection as Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to Day 181

Secondary outcomes (8)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Apr 2026Apr 2027

First posted25 Feb 2026
Study start27 Apr 2026
Primary completionApr 2027 (estimated)
Study completionApr 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model 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.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 32 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07432698
Sponsor's protocol ID: AK0406-1001
Status last verified: Oct 2026
First submitted: 14 Feb 2026
Last updated: 29 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
RecruitingPhase 1
A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants
Healthy Female Participants
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants

All Healthy Participants trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT07432698
Acronym / sponsor ID: AK0406-1001
Conditions: Healthy Participants
Keywords: Pharmacokinetics, Safety, Tolerability
Phase: Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 32 participants (estimated)
Lead sponsor: Shanghai Ark Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: Ark Biosciences Pty Ltd.
Study start: 27 Apr 2026 (actual)
Primary completion: Apr 2027 (estimated)
Study completion: Apr 2027 (estimated)
First posted: 25 Feb 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5
Model 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.

Arm	Type	Receives
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

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (11 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AK0406 150 mgSingle dose of AK0406 150 mg，subcutaneous injection	Drug	Cohort A: AK0406 150 mg
AK0406 300 mgSingle dose of AK0406 300 mg，subcutaneous injection	Drug	Cohort B：AK0406 300 mg
AK0406 600 mgSingle dose of AK0406 600 mg，subcutaneous injection	Drug	Cohort C：AK0406 600 mg
AK0406 900 mgSingle dose of AK0406 900 mg，subcutaneous injection	Drug	Cohort D：AK0406 900 mg
0.9% Sodium Chloride Injection as Placebo0.9% Sodium Chloride Injection, subcutaneous injection	Drug	Placebo

Primary outcome

Adverse events
Time frame: Up to Day 181
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.

8 secondary outcomes

Maximum concentration
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
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
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
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
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
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
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
Time frame: Baseline, Day 15, Day 31, Day 91, Day 181

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
Individual participant dataSharing planned: No

Related trials for Healthy Participants

Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
RecruitingPhase 1
A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants
Healthy Female Participants
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AK0406 150 mg, AK0406 300 mg and AK0406 600 mg in people with Healthy Participants, run by Shanghai Ark Biopharmaceutical Co., Ltd. at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (time frame: Up to Day 181). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07432698.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.