A Clinical Study of AK0610

Phase 1

Recruiting

• Conditions: Healthy Volunteer Study
• Interventions: Drug: AK0610 Injection solution; Drug: Placebo

• Registration Number: NCT06996704
• Lead Sponsor: Shanghai Ark Biopharmaceutical Co., Ltd.

Brief 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.

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 Timeline

• Study Start: 2024-02-29
• Study First Submitted: 2025-03-24
• Status Verified: 2025-04
• Study First Submitted QC: 2025-05-21
• Last Update Submitted: 2025-05-21
• Study First Posted: 2025-05-30
• Last Update Posted: 2025-05-30
• Primary Completion: 2025-06
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

1. Participants aged 18 - 50 (both males and females)
2. Males weighing ≥50 kg, females weighing ≥45 kg, and BMI 18-28 kg/m2.
3. Assessed by the investigator to be in good health with no clinically significant abnormalities.
4. Use of highly effective contraception within 1 year of administration.
5. Voluntary participation in clinical research and signing of written informed consent.

Exclusion Criteria

1. 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.
2. Active malignancy and/or a history of malignancy (except for basal cell carcinoma of the skin that has been treated without evidence of recurrence)
3. History of congenital or acquired immunodeficiency.
4. Acute illness, such as fever, infectious disease, diarrhea, etc., occurring within 1 week prior to the subject's first dose.
5. Major surgery within 3 months prior to screening or major surgery planned within 1 year of study drug administration.
6. Hypersensitivity to the active ingredient of AK0610 or any excipients.
7. Previous history of allergy to biologics or history of severe allergic reaction (e.g. hypotension, dyspnea, severe angioedema) to any drug.
8. Human immunodeficiency virus (HIV) antibody positive; hepatitis C virus (HCV) antibody positive or hepatitis B surface antigen (HBsAg) positive; syphilis spirochete antibody positive.
9. Systolic blood pressure ≥140 mmHg or <90 mmHg or diastolic blood pressure ≥90 mmHg or <60 mmHg, and pulse <55 or >100 beats/min.
10. ECG suggestive of prolonged QTcF (≥450 ms in both women and men). [QTcF= QT/(RR^0.33)]
11. 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.
12. Have received treatment with immune globulin or other blood products within 6 months prior to study drug administration
13. Have received treatment with monoclonal antibodies or other biological products within 6 months prior to administration of study drug.
14. 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.
15. 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.
16. Participating or have participated in another interventional clinical study of a monoclonal antibody or vaccine against RSV.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Escalation Phase Cohort 1: AK0610 Injection 100 mg or placebo 1 ml	AK0610 Injection solution	AK0610 100 mg or Placebo 1 ml，Intramuscular injection，once on Day 1.
Escalation Phase Cohort 1: AK0610 Injection 100 mg or placebo 1 ml	Placebo	AK0610 100 mg or Placebo 1 ml，Intramuscular injection，once on Day 1.
Escalation Phase Cohort 2: AK0610 Injection 300 mg or Placebo 3 ml	AK0610 Injection solution	AK0610 300 mg or Placebo 3 ml，Intramuscular injection，once on Day 1.
Escalation Phase Cohort 2: AK0610 Injection 300 mg or Placebo 3 ml	Placebo	AK0610 300 mg or Placebo 3 ml，Intramuscular injection，once on Day 1.
Escalation Phase Cohort 3: AK0610 Injection 300 mg or Placebo 3 ml	AK0610 Injection solution	AK0610 300 mg or Placebo 3 ml，Intravenous injection，once on Day 1.
Escalation Phase Cohort 3: AK0610 Injection 300 mg or Placebo 3 ml	Placebo	AK0610 300 mg or Placebo 3 ml，Intravenous injection，once on Day 1.
Escalation Phase Cohort 4: AK0610 Injection 1000 mg or Placebo 10 ml	AK0610 Injection solution	AK0610 1000 mg or Placebo 10 ml，Intravenous injection，once on Day 1.
Escalation Phase Cohort 4: AK0610 Injection 1000 mg or Placebo 10 ml	Placebo	AK0610 1000 mg or Placebo 10 ml，Intravenous injection，once on Day 1.
Escalation Phase Cohort 5: AK0610 Injection 3000 mg or Placebo 30 ml	AK0610 Injection solution	AK0610 3000 mg or Placebo 30 ml，Intravenous injection，once on Day 1.
Escalation Phase Cohort 5: AK0610 Injection 3000 mg or Placebo 30 ml	Placebo	AK0610 3000 mg or Placebo 30 ml，Intravenous injection，once on Day 1.
Expansion Phase Cohort 6: AK0610 Injection 300 mg or Placebo 3 ml	AK0610 Injection solution	AK0610 300 mg or Placebo 3 ml，Intramuscular injection，once on Day 1.
Expansion Phase Cohort 6: AK0610 Injection 300 mg or Placebo 3 ml	Placebo	AK0610 300 mg or Placebo 3 ml，Intramuscular injection，once on Day 1.
Expansion Phase Cohort 7: AK0610 Injection 600 mg or Placebo 6 ml	AK0610 Injection solution	AK0610 600mg or Placebo 6ml，Intramuscular injection，once on Day 1.
Expansion Phase Cohort 7: AK0610 Injection 600 mg or Placebo 6 ml	Placebo	AK0610 600mg or Placebo 6ml，Intramuscular injection，once on Day 1.

Primary Outcome Measures

Name	Time	Method
Incidence and severity of treatment-emergent adverse events (TEAEs)	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.

Secondary Outcome Measures

Name	Time	Method
Maximum Observed Serum Concentration (Cmax) of AK0610	Up to 361 days	The Cmax is the maximum observed serum concentration of AK0610.
Time to Reach Maximum Observed Serum Concentration (Tmax) of AK0610	Up to 361 days	The Tmax is defined as time at which maximum observed concentration of AK0610 (Cmax) was observed.
Area Under the serum concentration-time curve from time 0 to the last measurable concentration (AUC₀-t) of AK0610	Up to 361 days	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.
Area Under the serum concentration-time curve from time 0 to extrapolated to infinite time (AUC (0-infinity) ) of AK0610	Up to 361 days	The pharmacokinetic (PK) parameter AUC (0-infinity) was estimated based on the serum concentrations of AK0610.
Terminal Elimination Half Life (t1/2) of AK0610	Up to 361 days	Terminal phase elimination half-life (t1/2) is the time required for half of the drug to be eliminated from the serum.
Extravascular Clearance (CL/F (intramuscular administration)) of AK0610	Up to 361 days	Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.
Apparent Volume of Distribution (Vd/F (intramuscular administration)) of AK0610	Up to 361 days	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.
CL(IV administration) of AK0610	Up to 361 days	Clearance (CL) following intravenous administration will be calculated to quantify the rate of drug elimination from plasma.
Vd (IV administration) of AK0610	Up to 361 days	Volume of distribution (Vd) after intravenous dosing will be estimated to characterize the drug's tissue penetration relative to plasma
To assess the changes in serum RSV-neutralizing activity after a single intramuscular or intravenous injection of AK0610 in healthy Chinese subjects	Up to 361 days	Changes in serum anti-RSV neutralizing antibody titers
To assess the immunogenicity of a single intramuscular or intravenous injection of AK0610 in healthy Chinese subjects.	Up to 361 days	Serum positivity and titer of anti-drug antibodies against AK0610

Trial Locations

Locations (1)

The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital ）; 🇨🇳 Jinan, Shandong, China