RSV (Respiratory Syncytial Virus)
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
1 Years to 2 Years
Inclusion criteria
Inclusion criteria: 1. Infants aged >12 months to =35 weeks) with underlying conditions (e.g., Down syndrome and cleft lip) but no other risk factors may participate in the trial at the investigator's discretion during randomization; 2. The subject's father, mother, or legal guardian has signed an informed consent form; 3. The subject's father, mother, or legal guardian is able to understand and comply with the protocol requirements and procedures, including scheduled center follow-ups, telephone visits, and sample collection.
Exclusion criteria
Exclusion criteria: 1. Any fever (body temperature >=38.0°C, regardless of measurement method) or acute illness (defined as moderate or severe symptoms or signs) occurring within 7 days prior to administration; 2. Lower respiratory tract infection within 7 days prior to dosing; 3. History of urticaria, known allergy to multiple medications, or known allergy to immunoglobulin products or blood products; 4. Subjects with clear evidence of current active RSV infection or prior history of RSV infection; 5. Subjects with autoimmune diseases who are currently receiving or, in the investigator's judgment, are expected to receive immunomodulatory therapy during the trial (e.g., systemic glucocorticoids, excluding topical applications); 6. Subjects who have received or are expected to receive blood products, immunoglobulin products, or monoclonal/polyclonal antibodies (excluding the study drug) within the past 3 months or during the trial period; 7. Received RSV monoclonal antibodies within 3 half-lives prior to dosing; 8. Received any investigational drug or participated in any interventional study (excluding RSV monoclonal antibodies); 9. Known renal impairment or hepatic dysfunction at screening (including hepatic dysfunction due to known or suspected active or chronic hepatitis infection); 10. Known chronic lung disease (CLD)/bronchopulmonary dysplasia or clinically significant congenital respiratory anomalies requiring medical intervention (e.g., supplemental oxygen, corticosteroids, bronchodilators, or diuretics) within 6 months prior to screening; 11. Congenital heart disease (CHD) with significant hemodynamic changes, except for isolated CHD (e.g., patent ductus arteriosus, non-hemodynamically significant atrial septal defect or ventricular septal defect) and hemodynamically insignificant non-cyanotic cardiac lesions without pulmonary hypertension and not requiring daily medication; 12. Chronic epilepsy or progressive or unstable neurological disease; 13. History of or suspected life-threatening acute events, with investigator determination that the subject remains unsuitable for trial participation; 14. Known immunodeficiency, including human immunodeficiency virus (HIV) infection; 15. Maternal HIV infection (unless proven not transmitted to the subject); 16. Maternal administration of RSV vaccine during pregnancy; 17. Any other condition deemed by the investigator to potentially interfere with assessment of study drug endpoints or interpretation of study results; 18. Subject is a child of the investigator, a member of the investigator's team, or a sponsor staff member.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of medically attended lower respiratory tract infections (MALRTI) caused by RSV, confirmed by RT-PCR, within 150 days after dosing.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hospitalization rate due to RSV-induced LRTI confirmed by RT-PCR within 150 days post-administration (i.e., D1-D151);During the study period, the occurrence of adverse events (AE)/serious adverse events (SAE) and adverse events of special interest (AESI) (type, incidence rate, severity, and causality);Establish a population pharmacokinetic (PopPK) model for RB0026 injection in the pediatric population to characterize its PK profile and evaluate the impact of intrinsic/extrinsic factors on the PK characteristics of RB0026.;Serum anti-RSV neutralizing antibody titers and fold increase at different time points post-administration;Serum anti-drug antibody (ADA) positivity rate and neutralizing antibody (NAb) activity at different time points post-administration; | — |
Countries
China
Contacts
Public ContactZhong Nanshan/Sun Lihong
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed