Healthy Volunteer StudyPhase 1NCT06996704
A Clinical Study of AK0610
A Phase 1 study testing AK0610 Injection solution in people with Healthy Volunteer Study, run by Shanghai Ark Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The study consists of two parts: dose escalation and expansion. It includes five cohorts in the dose-escalation phase and two expansion cohorts based on pharmacokinetic data. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer Study
- What is being tested?
- AK0610 Injection solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- 1 siteChina
- Study dates
- 29 Feb 2024to 13 Sep 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants aged 18 - 50 (both males and females)
- Males weighing ≥50 kg, females weighing ≥45 kg, and BMI 18-28 kg/m2.
- Assessed by the investigator to be in good health with no clinically significant abnormalities.
- Use of highly effective contraception within 1 year of administration.
- Voluntary participation in clinical research and signing of written informed consent.
Who cannot join
- Clinically significant cardiovascular, respiratory, hepatic, renal, hematologic (e.g., bleeding disorders), gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric system disorders, or any other condition that, in the opinion of the Investigator, may jeopardize subject safety or validity of the study results, or that may result in the inability of the subject to complete the study in accordance with the protocol.
- Active malignancy and/or a history of malignancy (except for basal cell carcinoma of the skin that has been treated without evidence of recurrence)
- History of congenital or acquired immunodeficiency.
- Acute illness, such as fever, infectious disease, diarrhea, etc., occurring within 1 week prior to the subject's first dose.
- Major surgery within 3 months prior to screening or major surgery planned within 1 year of study drug administration.
- Hypersensitivity to the active ingredient of AK0610 or any excipients.
Show all 16Show fewer
- Previous history of allergy to biologics or history of severe allergic reaction (e.g. hypotension, dyspnea, severe angioedema) to any drug.
- Human immunodeficiency virus (HIV) antibody positive; hepatitis C virus (HCV) antibody positive or hepatitis B surface antigen (HBsAg) positive; syphilis spirochete antibody positive.
- Systolic blood pressure ≥140 mmHg or <90 mmHg or diastolic blood pressure ≥90 mmHg or <60 mmHg, and pulse <55 or >100 beats/min.
- ECG suggestive of prolonged QTcF (≥450 ms in both women and men). [QTcF= QT/(RR^0.33)]
- Use of any prescription, over-the-counter, herbal, proprietary, or health care product (other than birth control pills) within 14 days prior to study drug administration.
- Have received treatment with immune globulin or other blood products within 6 months prior to study drug administration
- Have received treatment with monoclonal antibodies or other biological products within 6 months prior to administration of study drug.
- Have received a live attenuated vaccination within 1 month prior to study drug administration, has received another vaccination within 14 days, or is scheduled to receive a vaccination within 1 year of study drug administration.
- Received any other investigational drug therapy within 3 months (or 5 half-lives, whichever is longer) prior to study drug administration, or plans to participate in another study within 1 year of study drug administration.
- Participating or have participated in another interventional clinical study of a monoclonal antibody or vaccine against RSV.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital ）
Jinan, Shandong
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation, and Expansion Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of AK0610 in Healthy Chinese Adults.
The study consists of two parts: dose escalation and expansion. It includes five cohorts in the dose-escalation phase and two expansion cohorts based on pharmacokinetic data.
Read the detailed description
This study is a Phase I clinical trial that is randomized, double-blind, placebo-controlled, and involves single-dose administration, dose-escalation, and an expansion phase. It evaluates the safety, tolerability, and pharmacokinetic profile of AK0610 in healthy Chinese adults.
The study consists of two parts. The dose-escalation phase includes five cohorts (100 mg i.m.; 300 mg i.m.; 300 mg i.v.; 1000 mg i.v.; 3000 mg i.v.), each consisting of 8 individuals (AK0610: Placebo = 3:1), who are administered doses in sequential increments.
Based on pharmacokinetic data, the dose-escalation phase will be expanded to include two additional dose cohorts (300 mg i.m.; 600 mg i.m.) of 48 individuals each (AK0610: Placebo = 3:1).
Each participant will undergo a Screening Period from Day -29 to Day -1. They will receive one dose on Day 1, an Inpatient Observation Period from Day -1 to Day 8, and a Blinded Follow-Up Period from Day 9 to Day 181. Subjects in the AK0610 group will also enter an open-label period from Day 182 to Day 361.
- Conditions
- Healthy Volunteer Study
- Being tested
- AK0610 Injection solution, Placebo
- Keywords
- Phase 1 study of AK0610
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK0610 Injection solutionDrug
Active Substance: AK0610 Pharmaceutical Form: Injection solution Route of Administration: Intramuscular injection or intravenous injection.
PlaceboDrug
Active Substance: Placebo Pharmaceutical Form: Injection Route of Administration: Intramuscular injection or intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| Escalation Phase Cohort 1: AK0610 Injection 100 mg or placebo 1 ml | Experimental | AK0610 100 mg or Placebo 1 ml，Intramuscular injection，once on Day 1. Receives: Drug: AK0610 Injection solution; Drug: Placebo |
| Escalation Phase Cohort 2: AK0610 Injection 300 mg or Placebo 3 ml | Experimental | AK0610 300 mg or Placebo 3 ml，Intramuscular injection，once on Day 1. Receives: Drug: AK0610 Injection solution; Drug: Placebo |
| Escalation Phase Cohort 3: AK0610 Injection 300 mg or Placebo 3 ml | Experimental | AK0610 300 mg or Placebo 3 ml，Intravenous injection，once on Day 1. Receives: Drug: AK0610 Injection solution; Drug: Placebo |
| Escalation Phase Cohort 4: AK0610 Injection 1000 mg or Placebo 10 ml | Experimental | AK0610 1000 mg or Placebo 10 ml，Intravenous injection，once on Day 1. Receives: Drug: AK0610 Injection solution; Drug: Placebo |
| Escalation Phase Cohort 5: AK0610 Injection 3000 mg or Placebo 30 ml | Experimental | AK0610 3000 mg or Placebo 30 ml，Intravenous injection，once on Day 1. Receives: Drug: AK0610 Injection solution; Drug: Placebo |
| Expansion Phase Cohort 6: AK0610 Injection 300 mg or Placebo 3 ml | Experimental | AK0610 300 mg or Placebo 3 ml，Intramuscular injection，once on Day 1. Receives: Drug: AK0610 Injection solution; Drug: Placebo |
| Expansion Phase Cohort 7: AK0610 Injection 600 mg or Placebo 6 ml | Experimental | AK0610 600mg or Placebo 6ml，Intramuscular injection，once on Day 1. Receives: Drug: AK0610 Injection solution; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment-emergent adverse events (TEAEs)
Capture the incidence and severity of adverse events using CTCAE v5.0, documenting all treatment-emergent adverse events (TEAEs) throughout the study period.
Measured: Up to 361 days
Secondary outcomes (11)
Maximum Observed Serum Concentration (Cmax) of AK0610
The Cmax is the maximum observed serum concentration of AK0610.
Measured: Up to 361 days
Time to Reach Maximum Observed Serum Concentration (Tmax) of AK0610
The Tmax is defined as time at which maximum observed concentration of AK0610 (Cmax) was observed.
Measured: Up to 361 days
Area Under the serum concentration-time curve from time 0 to the last measurable concentration (AUC₀-t) of AK0610
It represents the area under the curve of serum concentration versus time for the drug AK0610 from the time of administration until the last measurable concentration.
Measured: Up to 361 days
Area Under the serum concentration-time curve from time 0 to extrapolated to infinite time (AUC (0-infinity) ) of AK0610
The pharmacokinetic (PK) parameter AUC (0-infinity) was estimated based on the serum concentrations of AK0610.
Measured: Up to 361 days
Terminal Elimination Half Life (t1/2) of AK0610
Terminal phase elimination half-life (t1/2) is the time required for half of the drug to be eliminated from the serum.
Measured: Up to 361 days
Extravascular Clearance (CL/F (intramuscular administration)) of AK0610
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.
Measured: Up to 361 days
Apparent Volume of Distribution (Vd/F (intramuscular administration)) of AK0610
It represents the theoretical volume in which the drug is distributed in the body, calculated by dividing the dose by the concentration in the terminal elimination phase.
Measured: Up to 361 days
CL(IV administration) of AK0610
Clearance (CL) following intravenous administration will be calculated to quantify the rate of drug elimination from plasma.
Measured: Up to 361 days
Vd (IV administration) of AK0610
Volume of distribution (Vd) after intravenous dosing will be estimated to characterize the drug's tissue penetration relative to plasma
Measured: Up to 361 days
To assess the changes in serum RSV-neutralizing activity after a single intramuscular or intravenous injection of AK0610 in healthy Chinese subjects
Changes in serum anti-RSV neutralizing antibody titers
Measured: Up to 361 days
To assess the immunogenicity of a single intramuscular or intravenous injection of AK0610 in healthy Chinese subjects.
Serum positivity and titer of anti-drug antibodies against AK0610
Measured: Up to 361 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start29 Feb 2024
- Primary completion7 May 2025
- Study completion13 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteer StudyStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Ark Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996704
- Sponsor's protocol ID
- AK0610-2001
- Status last verified
- Oct 2026
- First submitted
- 24 Mar 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation, and Expansion Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of AK0610 in Healthy Chinese Adults.
- ClinicalTrials.gov ID
- NCT06996704
- Acronym / sponsor ID
- AK0610-2001
- Conditions
- Healthy Volunteer Study
- Keywords
- Phase 1 study of AK0610
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Shanghai Ark Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 7 May 2025 (actual)
- Study completion
- 13 Sep 2025 (actual)
- First posted
- 30 May 2025 (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.
The study consists of two parts: dose escalation and expansion. It includes five cohorts in the dose-escalation phase and two expansion cohorts based on pharmacokinetic data.
Detailed description
This study is a Phase I clinical trial that is randomized, double-blind, placebo-controlled, and involves single-dose administration, dose-escalation, and an expansion phase. It evaluates the safety, tolerability, and pharmacokinetic profile of AK0610 in healthy Chinese adults.
The study consists of two parts. The dose-escalation phase includes five cohorts (100 mg i.m.; 300 mg i.m.; 300 mg i.v.; 1000 mg i.v.; 3000 mg i.v.), each consisting of 8 individuals (AK0610: Placebo = 3:1), who are administered doses in sequential increments.
Based on pharmacokinetic data, the dose-escalation phase will be expanded to include two additional dose cohorts (300 mg i.m.; 600 mg i.m.) of 48 individuals each (AK0610: Placebo = 3:1).
Each participant will undergo a Screening Period from Day -29 to Day -1. They will receive one dose on Day 1, an Inpatient Observation Period from Day -1 to Day 8, and a Blinded Follow-Up Period from Day 9 to Day 181. Subjects in the AK0610 group will also enter an open-label period from Day 182 to Day 361.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Escalation Phase Cohort 1: AK0610 Injection 100 mg or placebo 1 ml | Experimental | Drug: AK0610 Injection solution, Drug: PlaceboAK0610 100 mg or Placebo 1 ml，Intramuscular injection，once on Day 1. |
| Escalation Phase Cohort 2: AK0610 Injection 300 mg or Placebo 3 ml | Experimental | Drug: AK0610 Injection solution, Drug: PlaceboAK0610 300 mg or Placebo 3 ml，Intramuscular injection，once on Day 1. |
| Escalation Phase Cohort 3: AK0610 Injection 300 mg or Placebo 3 ml | Experimental | Drug: AK0610 Injection solution, Drug: PlaceboAK0610 300 mg or Placebo 3 ml，Intravenous injection，once on Day 1. |
| Escalation Phase Cohort 4: AK0610 Injection 1000 mg or Placebo 10 ml | Experimental | Drug: AK0610 Injection solution, Drug: PlaceboAK0610 1000 mg or Placebo 10 ml，Intravenous injection，once on Day 1. |
| Escalation Phase Cohort 5: AK0610 Injection 3000 mg or Placebo 30 ml | Experimental | Drug: AK0610 Injection solution, Drug: PlaceboAK0610 3000 mg or Placebo 30 ml，Intravenous injection，once on Day 1. |
| Expansion Phase Cohort 6: AK0610 Injection 300 mg or Placebo 3 ml | Experimental | Drug: AK0610 Injection solution, Drug: PlaceboAK0610 300 mg or Placebo 3 ml，Intramuscular injection，once on Day 1. |
| Expansion Phase Cohort 7: AK0610 Injection 600 mg or Placebo 6 ml | Experimental | Drug: AK0610 Injection solution, Drug: PlaceboAK0610 600mg or Placebo 6ml，Intramuscular injection，once on Day 1. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants aged 18 - 50 (both males and females)
- Males weighing ≥50 kg, females weighing ≥45 kg, and BMI 18-28 kg/m2.
- Assessed by the investigator to be in good health with no clinically significant abnormalities.
- Use of highly effective contraception within 1 year of administration.
- Voluntary participation in clinical research and signing of written informed consent.
Key exclusion criteria (16 listed)
- Clinically significant cardiovascular, respiratory, hepatic, renal, hematologic (e.g., bleeding disorders), gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric system disorders, or any other condition that, in the opinion of the Investigator, may jeopardize subject safety or validity of the study results, or that may result in the inability of the subject to complete the study in accordance with the protocol.
- Active malignancy and/or a history of malignancy (except for basal cell carcinoma of the skin that has been treated without evidence of recurrence)
- History of congenital or acquired immunodeficiency.
- Acute illness, such as fever, infectious disease, diarrhea, etc., occurring within 1 week prior to the subject's first dose.
- Major surgery within 3 months prior to screening or major surgery planned within 1 year of 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 |
|---|---|---|
| AK0610 Injection solutionActive Substance: AK0610 Pharmaceutical Form: Injection solution Route of Administration: Intramuscular injection or intravenous injection. | Drug | Escalation Phase Cohort 1: AK0610 Injection 100 mg or placebo 1 ml, Escalation Phase Cohort 2: AK0610 Injection 300 mg or Placebo 3 ml, Escalation Phase Cohort 3: AK0610 Injection 300 mg or Placebo 3 ml, Escalation Phase Cohort 4: AK0610 Injection 1000 mg or Placebo 10 ml, Escalation Phase Cohort 5: AK0610 Injection 3000 mg or Placebo 30 ml, Expansion Phase Cohort 6: AK0610 Injection 300 mg or Placebo 3 ml, Expansion Phase Cohort 7: AK0610 Injection 600 mg or Placebo 6 ml |
| PlaceboActive Substance: Placebo Pharmaceutical Form: Injection Route of Administration: Intramuscular injection or intravenous injection | Drug | Escalation Phase Cohort 1: AK0610 Injection 100 mg or placebo 1 ml, Escalation Phase Cohort 2: AK0610 Injection 300 mg or Placebo 3 ml, Escalation Phase Cohort 3: AK0610 Injection 300 mg or Placebo 3 ml, Escalation Phase Cohort 4: AK0610 Injection 1000 mg or Placebo 10 ml, Escalation Phase Cohort 5: AK0610 Injection 3000 mg or Placebo 30 ml, Expansion Phase Cohort 6: AK0610 Injection 300 mg or Placebo 3 ml, Expansion Phase Cohort 7: AK0610 Injection 600 mg or Placebo 6 ml |
Primary outcome
Incidence and severity of treatment-emergent adverse events (TEAEs)
Time frame: Up to 361 days
Capture the incidence and severity of adverse events using CTCAE v5.0, documenting all treatment-emergent adverse events (TEAEs) throughout the study period.
11 secondary outcomes
Maximum Observed Serum Concentration (Cmax) of AK0610
Time frame: Up to 361 days
Time to Reach Maximum Observed Serum Concentration (Tmax) of AK0610
Time frame: Up to 361 days
Area Under the serum concentration-time curve from time 0 to the last measurable concentration (AUC₀-t) of AK0610
Time frame: Up to 361 days
Area Under the serum concentration-time curve from time 0 to extrapolated to infinite time (AUC (0-infinity) ) of AK0610
Time frame: Up to 361 days
Terminal Elimination Half Life (t1/2) of AK0610
Time frame: Up to 361 days
Extravascular Clearance (CL/F (intramuscular administration)) of AK0610
Time frame: Up to 361 days
Apparent Volume of Distribution (Vd/F (intramuscular administration)) of AK0610
Time frame: Up to 361 days
CL(IV administration) of AK0610
Time frame: Up to 361 days
Vd (IV administration) of AK0610
Time frame: Up to 361 days
To assess the changes in serum RSV-neutralizing activity after a single intramuscular or intravenous injection of AK0610 in healthy Chinese subjects
Time frame: Up to 361 days
To assess the immunogenicity of a single intramuscular or intravenous injection of AK0610 in healthy Chinese subjects.
Time frame: Up to 361 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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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 AK0610 Injection solution in people with Healthy Volunteer Study, run by Shanghai Ark Biopharmaceutical Co., Ltd. at 1 site in China.
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 16 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: finished, as of the sponsor's last update on 28 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 China. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence and severity of treatment-emergent adverse events (TEAEs) (time frame: Up to 361 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2026.