Actively Recruiting
A Clinical Study of AK0610
Led by Shanghai Ark Biopharmaceutical Co., Ltd. · Updated on 2025-05-30
136
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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, and body mass index between 18 and 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
You will not qualify if you...
- Presence of clinically significant disorders in cardiovascular, respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric systems, or other conditions affecting safety or study validity
- Active malignancy or history of malignancy except treated basal cell carcinoma without recurrence
- History of congenital or acquired immunodeficiency
- Acute illness within 1 week prior to first dose (fever, infection, diarrhea)
- Major surgery within 3 months before screening or planned within 1 year after dosing
- Hypersensitivity to AK0610 or any excipients
- History of severe allergic reactions or allergy to biologics
- Positive tests for HIV, hepatitis B or C, or syphilis
- Blood pressure outside specified ranges or abnormal pulse rate
- ECG indicating prolonged QTcF
- Use of any drugs except birth control within 14 days prior to dosing
- Treatment with immune globulin or blood products within 6 months prior to dosing
- Treatment with monoclonal antibodies or biological products within 6 months prior to dosing
- Recent or planned vaccination within defined time frames
- Participation in other investigational drug studies within 3 months prior or planned within 1 year
- Participation in other monoclonal antibody or RSV vaccine studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
7
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here