Phase Ib/IIa Clinical Trial of SIBP-A16 Injection in Premature Infants and Full-term Infants

NCT07363837 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: SIBP-A16-002
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Syncytial Virus (RSV)

Keywords

RSV; Preliminary efficacy; Premature and term infants; Pharmacokinetics; Safety; Tolerability

Outcome Measures

Primary Outcomes (4)

• AE (Adverse Events)

  That is adverse events, any adverse events that occurred to the participant during the study period.

  From day 1 to day 360 after administration

• SAE (Serious Adverse Events)

  That is serious adverse events, any serious adverse events that occurred to the participant during the study period.

  From day 1 to day 360 after administration

• 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.

  From day 1 to day 360 after administration

• New-onset chronic diseases (NOCD)

  NOCD refer to chronic non-communicable diseases that emerge during clinical trials.

  From day 1 to day 360 after administration

Secondary Outcomes (5)

• 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

Study Arms (3)

Experimental group

EXPERIMENTAL

SIBP-A16 injection

Drug: SIBP-A16 injection

Positive Comparator

ACTIVE COMPARATOR

Nirsevimab

Drug: Nirsevimab

Placebo

PLACEBO COMPARATOR

SIBP-A16 buffer solution

Drug: SIBP-A16 buffer solution

Interventions

SIBP-A16 injection DRUG

Strength: dose 1, dose 2 and dose 3. Single administration via intramuscular or intravenous injection.

Experimental group

Nirsevimab DRUG

Participants will receive one dose of Nisibimab via intramuscular injection.

Positive Comparator

SIBP-A16 buffer solution DRUG

Participants in the placebo group will be assigned to four dose cohorts, and they will receive one dose of Placebo via intramuscular injection.

Placebo

Eligibility Criteria

• Age: 0 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Known to have chronic lung disease (CLD)/bronchopulmonary dysplasia;
• Congenital respiratory abnormalities with clinical significance;
• Suffering from congenital heart disease (CHD) accompanied by significant hemodynamic changes;
• Suffering from chronic epilepsy or progressive or unstable neurological disorders;
• Those who have previously experienced or are suspected to have experienced life-threatening acute events, and are still deemed unsuitable for participating in clinical trials by the researchers;

Sponsors & Collaborators

• Shanghai Institute Of Biological Products: lead

Study Sites (1)

West China Second Hospital, Sichuan University

Chengdu, Sichuan, China

Location

MeSH Terms

Conditions

Premature Birth

Interventions

nirsevimab

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Hanwen Liu

  West China Second Hospital, Sichuan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dandan Chen, Master

CONTACT

86-021-62800991; ddchen.sh@sinopharm.com

Bin Wu, Bachelor

CONTACT

02162800991; wubin50@sinopharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 23, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)