Phase Ib/IIa Clinical Trial of SIBP-A16 Injection in Premature Infants and Full-term Infants
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 (ges... [+5]
Any fever (≥37.5°C, axillary temperature) or acute illness (defined as the prese... [+20]