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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
SIBP-A16 injection
Biological/VaccineSingle administration via intramuscular or intravenous injection. All participants received a single injection of the corresponding dose.
Nirsevimab
Biological/VaccineSingle administration via intramuscular.
SIBP-A16 buffer solution
Other interventionSingle administration via intramuscular or intravenous injection. All participants received a single injection of the corresponding dose.
Treatment groups
140 Participants
are divided into 3 treatment groupsGroup A: SIBP-A16 injectionExperimental treatment 1 intervention
Group B: NirsevimabActive comparator 1 intervention
Group C: SIBP-A16 buffer solutionPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
AE (Adverse Events)
That is adverse events, any adverse events that occurred to the participant during the study period.
Time frame
From day 1 to day 361 after administration2
SAE (Serious Adverse Events)
That is serious adverse events, any serious adverse events that occurred to the participant during the study period.
Time frame
From day 1 to day 361 after administration3
Adverse Event of Special Interest (AESI)
Adverse events defined in the protocol that require special attention, such as abnormal liver function, etc.
Time frame
From day 1 to day 361 after administrationSecondary outcomes
1
AUC (Area Under The Plasma Concentration Versus Time Curve)
It shows the degree to which a drug is absorbed and used in the body.
Time frame
Based on multiple pharmacokinetic blood collection points specified in the protocol2
Cmax (Peak Plasma Concentration)
It shows the highest plasma concentration of a drug that can be achieved after administration.
Time frame
Based on multiple pharmacokinetic blood collection points specified in the protocol3
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.
Time frame
Based on multiple pharmacokinetic blood collection points specified in the protocolOther outcomes
1
Level of Anti-drug antibody (ADA)
If ADA is positive, further check the levels of neutralizing antibodies against SIBP-A16 or neutralizing antibodies against Nisevere monoclonal antibody
Time frame
Before injection, on the 15th, 31st, 91st, 151st, 271st, and 361st days after administrationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov