A Clinical Trial of SIBP-A16 Injection in Healthy Adults
ConditionRespiratory Syncytial Virus (RSV)
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorShanghai Institute Of Biological Products
About this trial
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
Eligibility criteria
Qualifiers
Healthy individuals aged 18 to 45 on the day of enrollment, regardless of gender.
Male body weight ≥ 50.0 kg, female body weight ≥ 45.0 kg, BMI between 19.0 and 27.0 kg/m2 (including critical values).
Screening period physical examination, vital sign examination, 12 lead electrocardiogram, chest X-ray or clinical laboratory examination, and other auxiliary examination results show normal or abnormal without clinical significance as judged by the researcher.
Individuals who voluntarily participate in clinical trials and sign informed consent forms.
Disqualifiers
Known to have a history of serious clinical diseases such as mental system, circulatory system, endocrine system, digestive system, respiratory system, hematological and metabolic abnormalities, or any other diseases that can interfere with the test results.
Individuals with a history of drug allergies or specific allergies, or individuals with allergies, or those known to be allergic to the components or analogues of this drug.
During the screening period, individuals with abnormal results from physical examination, laboratory tests and clinical significance were identified by the researchers as having an impact on the evaluation of this trial.
During the screening period, male individuals with QTcF ≥ 450 milliseconds and female individuals with QTcF ≥ 470 milliseconds on electrocardiogram.
Trial design
Treatments tested in this trial
- SIBP-A16 injection
- Nirsevimab
- SIBP-A16 buffer solution
Treatment groups
140 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov