Actively Recruiting
A Randomized, Double-blind, Placebo/Positive Control Phase Ia Clinical Trial Evaluating the Safety, Tolerability, and Pharmacokinetics 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a randomized, double-blind, placebo and positive control Phase Ia clinical trial to evaluate the safety, tolerability, and pharmacokinetics of the SIBP-A16 injection in healthy adults aged 18 to 45. The study focuses on understanding how this injection behaves in the body and its safety profile. It involves healthy volunteers without significant medical conditions to ensure reliable results for the Respiratory Syncytial Virus (RSV) research. Participants will be assigned randomly to different groups organized in five queues, with varying doses of SIBP-A16 injection, placebo, or the active comparator Nirsevimab. The injections will be given either intramuscularly or intravenously in single doses across four different dose levels. Each queue undergoes a 14-day safety observation before the next dose level is administered based on safety committee review. During the study, participants will be monitored for adverse events, serious adverse events, and special adverse events of interest from day one up to 361 days after administration. Blood samples will be collected to measure drug levels over time, including peak concentration and time to peak. Various health assessments like physical exams, vital signs, ECGs, chest X-rays, and lab tests will be performed to ensure participant safety and measure outcomes throughout the nearly one-year follow-up.
CONDITIONS
Brief Title
A Clinical Trial of SIBP-A16 Injection in Healthy Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy individuals aged 18 to 45 years on the day of enrollment, any gender
- Male body weight at least 50.0 kg, female body weight at least 45.0 kg
- Body mass index (BMI) between 19.0 and 27.0 kg/m2, including boundary values
- Normal or clinically insignificant abnormalities in physical exam, vital signs, ECG, chest X-ray, or lab tests as judged by the researcher
- Voluntary participation with signed informed consent
- Able to communicate well and understand study requirements
You will not qualify if you...
- History of serious diseases affecting mental, circulatory, endocrine, digestive, respiratory, blood, or metabolic systems
- History of drug allergies, specific allergies, or known allergy to study drug components
- Abnormal screening results with clinical significance impacting trial evaluation
- Male with QTcF 450 ms or greater, female with QTcF 470 ms or greater on ECG
- Received monoclonal or polyclonal antibody drugs within 6 months prior to screening
- Received immunoglobulin or blood products within 6 months prior to screening
- Received passive immune agents, immunosuppressants, or corticosteroids within 6 months prior to screening
- Acute illnesses such as fever of 37.3°C or higher or diarrhea within 1 week before first medication
- Symptoms or signs of upper respiratory tract infection within 2 weeks before first medication
- Received RSV vaccine in the past
- Received any vaccine within 30 days prior to screening
- Smoked at least 5 cigarettes per day within 3 months prior or unable to quit during trial
- Average weekly alcohol consumption of 14 or more units within 3 months prior or unable to abstain during trial
- History of long-term excessive tea, coffee, or caffeinated beverage consumption
- Used any medication or health supplement within 14 days prior to screening
- History of drug abuse or dependence within 1 year prior to screening
- Participated in any drug clinical trials with investigational drug use within 3 months prior
- History of blood donation or significant bleeding within 4 weeks prior or plans to donate during study
- Pregnant or lactating women
- Plans to conceive, donate sperm or eggs, or inability to use effective contraception during trial (including partners)
- Special dietary requirements preventing normal diet
- Other conditions affecting compliance or suitability as judged by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 days
Participants receive a single injection of SIBP-A16, Nirsevimab, or placebo at varying doses via intramuscular or intravenous injection.
1 administration visit followed by several safety observation visits over 14 days
Duration - Up to 361 days
Participants are monitored for adverse events and pharmacokinetic outcomes for up to 361 days after administration.
Multiple follow-up visits for safety and pharmacokinetic assessments
Trial Site Locations
Total: 1 location
1
Wuhan Jinyintan Hospital
Wuhan, China
Actively Recruiting
Research Team
D
Dan dan Chen, Master
B
Bin Wu, Bachelor
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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