A Randomized, Double-blind, Placebo/Positive Control, Dose-finding Phase Ib/IIa Clinical Trial Evaluating the Safety, Tolerability, and Pharmacokinetics of SIBP-A16 Injection in Premature Infants and Full-term Infants
Overview
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Shanghai Institute Of Biological Products
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- AE (Adverse Events)
Overview
Brief Summary
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.
Detailed Description
This study established three study groups: the test drug group, the placebo group, and the positive control group. Four dose cohorts were set up: Cohort 1 (Dose 1), Cohort 2 (Dose 2), Cohort 3 (Dose 3), and Cohort 4 (Dose 2). A total of 36 participants were enrolled. The drug will be administered via intramuscular injection as a single dose. Initially, Cohort 1 enrolled 7 participants, who were randomly assigned to receive either one dose of the test drug or placebo. After completing the initial 14-day safety observation, if the dose escalation termination criteria were not triggered, participants were enrolled into Cohort 2 (11 participants, randomly assigned to receive either one dose of the test drug or placebo). Once Cohort 2 was fully enrolled, participants could be enrolled into Cohort 4 (7 participants, randomly assigned to receive either one dose of the positive control drug or placebo). After Cohort 2 completed the 14-day safety observation, participants were enrolled into Cohort 3 (11 participants, randomly assigned to receive either one dose of the test drug or placebo) following the same procedure. If the dose escalation termination criteria were triggered, the Data Monitoring Committee (DMC) would conduct a safety assessment and discuss with the research team and sponsor whether to terminate the dose escalation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 0 Months to 12 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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;
- •Parents/legal guardians of trial participants are able to understand and comply with the requirements and procedures of the protocol, including scheduled center visits, telephone interviews, and blood sample collection;
- •Participants can complete the follow-up period, which is approximately 1 year after the administration of the study drug.
Exclusion Criteria
- •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;
- •Those who have received non-oral inactivated vaccines or component vaccines within 7 days before administration;
- •Having received a non-oral live attenuated vaccine within 30 days prior to drug administration;
- •Participants who have received any medication within 7 days prior to drug administration, except for: a) various vitamins and iron supplements; b) systemic over-the-counter medications (such as analgesics) for common pediatric symptoms, which may be used occasionally, as determined by the investigator;
- •Participants with autoimmune diseases who are currently receiving, or are expected to receive according to the investigator's judgment, immunosuppressive therapy (including steroids, excluding topical steroids) during the trial period;
- •Have previously used or are expected to receive blood products or immunoglobulin products during the trial period;
- •Known renal dysfunction or liver dysfunction;
Arms & Interventions
Experimental group
SIBP-A16 injection
Intervention: SIBP-A16 injection (Drug)
Positive Comparator
Nirsevimab
Intervention: Nirsevimab (Drug)
Placebo
SIBP-A16 buffer solution
Intervention: SIBP-A16 buffer solution (Drug)
Outcomes
Primary Outcomes
AE (Adverse Events)
Time Frame: From day 1 to day 360 after administration
That is adverse events, any adverse events that occurred to the participant during the study period.
SAE (Serious Adverse Events)
Time Frame: From day 1 to day 360 after administration
That is serious adverse events, any serious adverse events that occurred to the participant during the study period.
Adverse Event of Special Interest (AESI)
Time Frame: From day 1 to day 360 after administration
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)
Time Frame: From day 1 to day 360 after administration
NOCD refer to chronic non-communicable diseases that emerge during clinical trials.
Secondary Outcomes
- AUC (Area Under The Plasma Concentration Versus Time Curve)(Before injection, on the 7th, 30th, 90th, 150th and 360th days after administration)
- Cmax (Peak Plasma Concentration)(Before injection, on the 7th, 30th, 90th, 150th and 360th days after administration)
- Tmax (Peak Time)(Before injection, on the 7th, 30th, 90th, 150th and 360th days after administration)
- Detecting RSV neutralizing antibody activity at various time points(Before injection, on the 7th, 30th, 90th, 150th and 360th days after administration)
- Level of Anti-drug antibody (ADA)(Before injection, on the 30th, 150th and 360th days after administration)