Actively Recruiting
A Clinical Trial of SIBP-A16 Injection in Healthy Adults
Led by Shanghai Institute Of Biological Products · Updated on 2025-11-25
140
Participants Needed
1
Research Sites
88 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a randomized, double-blind, placebo/positive control Phase Ia clinical trial evaluating the safety, tolerability, and pharmacokinetics of SIBP-A16 injection in healthy adults
CONDITIONS
Official Title
A Clinical Trial of SIBP-A16 Injection in Healthy Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adults aged 18 to 45 years at enrollment, any gender
- Male weight at least 50.0 kg, female weight at least 45.0 kg
- Body mass index between 19.0 and 27.0 kg/m2 inclusive
- Normal or clinically insignificant abnormal results on physical exam, vital signs, ECG, chest X-ray, and lab tests
- Voluntary participation with signed informed consent
- Ability to communicate and comply with study requirements
You will not qualify if you...
- History of serious diseases affecting mental, circulatory, endocrine, digestive, respiratory, hematological, or metabolic systems
- History of allergies to drugs or components of the study drug
- Clinically significant abnormal physical or lab findings during screening
- Prolonged QTcF interval (≥450 ms for males, ≥470 ms for females) on ECG
- Use of monoclonal/polyclonal antibodies within 6 months before screening
- Use of immunoglobulin, blood products, passive immune agents, immunosuppressants, or corticosteroids within 6 months before screening
- Acute illness such as fever ≥37.3°C or diarrhea within 1 week before first dose
- Symptoms of acute upper respiratory infection within 2 weeks before first dose
- Previous receipt of respiratory syncytial virus (RSV) vaccine
- Any vaccine received within 30 days before screening
- Smoking at least 5 cigarettes per day in the 3 months before screening or inability to quit during the trial
- Average weekly alcohol consumption of ≥14 units in the 3 months before screening or inability to abstain during the trial
- History of long-term excessive intake of tea, coffee, or caffeinated beverages
- Use of any medication or health supplements within 14 days before screening
- History of drug abuse or dependence in the past year
- Participation in drug clinical trials with investigational drugs in the past 3 months
- Blood donation or significant bleeding in the 4 weeks before screening or plans to donate during the study
- Pregnant or breastfeeding women
- Plans to conceive, donate sperm or eggs, or inability to use effective contraception during the trial (including partners)
- Special dietary requirements preventing a normal diet
- Any other condition judged by researchers to affect compliance or suitability for the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Wuhan Jinyintan Hospital
Wuhan, China
Actively Recruiting
Research Team
D
Dan dan Chen, Master
CONTACT
B
Bin Wu, Bachelor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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