This trial employs a randomized, double-blind, placebo/positive control, and dose-finding design to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of SIBP-A16 injection in premature and term infants.
During screening, infants within 1 year of age, including premature infants (gestational age ≥29 to <35 weeks) and full-term infants (gestational age ≥35 weeks), with underlying diseases but no other risk factors, are allowed to participate in the trial;
Infants with a body weight ≥3 kg at screening;
Infants who are entering their first RSV infection season at screening;
Parents/legal guardians of trial participants have signed the informed consent form;
Any fever (≥37.5°C, axillary temperature) or acute illness (defined as the presence of moderate or severe symptoms or signs) occurring within 7 days prior to drug administration;
Having experienced Lower Respiratory Tract Infections (LRTI) within the previous 7 days prior to randomization, or having active LRTI at the time of randomization;
Individuals with chronic eczema or urticaria, or those with an allergic constitution who are allergic to multiple drugs, or those with a known history of allergy to immunoglobulin products, blood products, other exogenous proteins, or any components of this product;
Had a history of RSV infection before randomization, or had active RSV infection at the time of randomization;
Parallel
SIBP-A16 injection
DrugStrength: dose 1, dose 2 and dose 3. Single administration via intramuscular or intravenous injection.
Nirsevimab
DrugParticipants will receive one dose of Nisibimab via intramuscular injection.
SIBP-A16 buffer solution
DrugParticipants in the placebo group will be assigned to four dose cohorts, and they will receive one dose of Placebo via intramuscular injection.
AE (Adverse Events)
That is adverse events, any adverse events that occurred to the participant during the study period.
SAE (Serious Adverse Events)
That is serious adverse events, any serious adverse events that occurred to the participant during the study period.
Adverse Event of Special Interest (AESI)
Adverse events defined in the protocol that require special attention, such as abnormal liver function, anaphylactic reaction, hypersensitivity reaction, etc.
New-onset chronic diseases (NOCD)
NOCD refer to chronic non-communicable diseases that emerge during clinical trials.
AUC (Area Under The Plasma Concentration Versus Time Curve)
It shows the degree to which a drug is absorbed and used in the body.
Cmax (Peak Plasma Concentration)
It shows the highest plasma concentration of a drug that can be achieved after administration.
Tmax (Peak Time)
That is peak time of drug action, it shows the time required to reach the maximum concentration on the participant plasma concentration curve after administration.
Detecting RSV neutralizing antibody activity at various time points
The RSV neutralizing assay was used to analyze the neutralizing activity of participants against RSV at various time points (before administration, and on days 7, 30, 90, 150, and 360 after administration).
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