Actively Recruiting
A Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation and Expansion Phase I Study to Evaluate Safety and Pharmacokinetics of AK0610 in Healthy Chinese Adults
Led by Shanghai Ark Biopharmaceutical Co., Ltd. · Updated on 2025-05-30
136
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase I clinical trial to evaluate the safety, tolerability, and pharmacokinetic profile of AK0610 in healthy Chinese adults aged 18 to 50. The study is randomized, double-blind, and placebo-controlled, focusing on single-dose administration with dose escalation and expansion phases. The trial involves healthy volunteers to understand how the body processes AK0610 and to monitor any side effects. The trial has two parts: a dose-escalation phase with five cohorts receiving increasing doses of AK0610 or placebo either intramuscularly or intravenously, and an expansion phase with two additional cohorts based on pharmacokinetic data. Doses range from 100 mg to 3000 mg, administered once on Day 1. Participants receive either AK0610 or placebo in a 3:1 ratio in all cohorts. Participants undergo a screening period from Day -29 to Day -1, followed by the dosing on Day 1 and an inpatient observation period until Day 8. Afterward, there is a blinded follow-up period lasting until Day 181, with those receiving AK0610 entering an open-label period from Day 182 to Day 361. Researchers will monitor adverse events, measure serum drug concentrations, and assess immunogenicity and RSV-neutralizing activity throughout the study.
CONDITIONS
Brief Title
A Clinical Study of AK0610
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 to 50 years (both males and females)
- Males weighing at least 50 kg, females weighing at least 45 kg
- Body mass index (BMI) between 18 and 28 kg/m2
- Assessed by investigator to be in good health with no significant abnormalities
- Use of highly effective contraception within 1 year before dosing
- Voluntary participation with signed informed consent
You will not qualify if you...
- Clinically significant disorders affecting safety or study validity (cardiovascular, respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric)
- Active or history of malignancy except treated basal cell carcinoma without recurrence
- History of congenital or acquired immunodeficiency
- Acute illness such as fever or infection within 1 week prior to dosing
- Major surgery within 3 months before screening or planned within 1 year after dosing
- Hypersensitivity to AK0610 or excipients
- History of allergy to biologics or severe allergic reactions
- Positive for HIV, hepatitis B or C, or syphilis antibodies
- Abnormal blood pressure or pulse rates outside defined ranges
- ECG with prolonged QTcF interval
- Use of any medication or health product (other than birth control pills) within 14 days before dosing
- Treatment with immune globulin, blood products, monoclonal antibodies, or biologicals within 6 months before dosing
- Recent live attenuated vaccination within 1 month or other vaccination within 14 days before dosing
- Participation in other investigational drug studies within 3 months or plans to participate within 1 year
- Previous participation in monoclonal antibody or RSV vaccine studies within 1 year before dosing or during study period
- Any condition judged by investigator to jeopardize safety or study results or ability to complete the study according to protocol
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 9 days
Participants receive a single dose of AK0610 or placebo via intramuscular or intravenous injection and stay inpatient for observation.
Inpatient observation from Day -1 to Day 8
Duration - Up to 173 days
Participants are monitored in a blinded manner for safety and pharmacokinetics.
Follow-up visits during Days 9 to 181
Duration - Up to 180 days
Participants in the AK0610 group continue open-label monitoring for safety and pharmacokinetics.
Follow-up visits during Days 182 to 361
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital ）
Jinan, Shandong, China
Actively Recruiting
Research Team
N
Nina Shen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
7
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