Respiratory syncytial virus
Conditions
Interventions
Low-dose RB0026 injection group:Single intramuscular injection of 1 ml (100 mg RB0026)
Medium-Dose RB0026 Injection Group:Single intramuscular injection of 1.5 ml (150 mg RB0026)
High-dose RB0026 injection group:Single intramuscular injection of 2 mL (200 mg RB0026)
Placebo Group RB0026:Single intramuscular injection of 1–2 mL (0 mg RB0026)
Sponsors
Chengdu Women and Children's Medical Center
Eligibility
Sex/Gender
All
Age
No minimum to 1 Years
Inclusion criteria
Inclusion criteria: Except for item 3 below, the inclusion criteria for Phase Ib and Phase II are identical; subjects must meet all of the following criteria to be enrolled in the trial: 1. Healthy preterm infants (gestational age >=29 to =35 weeks) under 1 year of age. Infants with underlying conditions (e.g., Down syndrome, cleft lip) but no other risk factors are eligible for participation; 2. Weight >= 3.0 kg at screening; 3. Infants experiencing their first RSV infection season at randomization (applies to Phase II, not Phase Ib); 4. Informed consent obtained from the subject's parent(s)/legal guardian(s); 5. The subject's parent(s)/legal guardian(s) are able to understand and comply with protocol requirements and procedures, including scheduled center visits, telephone follow-ups, and sample collection.
Exclusion criteria
Exclusion criteria: The exclusion criteria for both Phase Ib and Phase II of this trial are identical. Subjects meeting any of the following criteria must be excluded: 1. Any fever (body temperature >=38.0°C, by any method of temperature measurement) or acute illness (defined as the presence of moderate or severe symptoms or signs) within 7 days prior to dosing; 2. Lower respiratory tract infection within 7 days prior to dosing; 3. History of urticaria, known allergies to multiple medications, or known allergies to immunoglobulin products or blood products; 4. Current active RSV infection or prior history of RSV infection; 5. Receipt of any medical treatment (long-term or temporary administration) within 7 days prior to dosing, except for: a) Various vitamins, iron supplements, DHA, etc.; b) Systemic over-the-counter medications for common pediatric symptoms (e.g., analgesics, topical agents) as occasionally used at the investigator's discretion; 6. Individuals with autoimmune diseases currently receiving or expected to receive immunomodulatory therapy during the trial period (e.g., systemic glucocorticoids, excluding topical applications) at the investigator's discretion; 7. Use of blood products, immunoglobulin preparations, or monoclonal/polyclonal antibodies within the past 3 months or anticipated use during the trial (excluding the investigational product); 8. Known renal impairment or hepatic dysfunction (including known or suspected active or chronic hepatitis infection); 9. Known chronic lung disease (CLD)/bronchopulmonary dysplasia or clinically significant congenital respiratory anomalies; 10. Congenital heart disease (CHD) with significant hemodynamic changes, except isolated CHD (e.g., patent ductus arteriosus, non-hemodynamically significant atrial septal defect, or small ventricular septal defect); 11. Chronic epilepsy or progressive/unstable neurological disease; 12. History of life-threatening acute events (or suspected occurrence thereof), with investigator determination of current unsuitability for clinical trial participation; 13. Known immunodeficiency, including human immunodeficiency virus (HIV) infection; 14. Maternal HIV infection (unless proven not transmitted to subject); 15. Received any anti-RSV monoclonal antibody or RSV vaccine, including maternal RSV vaccination during pregnancy; 16. Received any investigational drug or participated in any interventional study; 17. Any other condition deemed by the investigator to potentially interfere with the assessment of the study drug or interpretation of study results. 18. Subject is the child of the investigator, their subordinate research staff, or the sponsor's personnel.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of AE/SAE and AESI during the study period (type, incidence rate, severity, and causality);The incidence of abnormalities in physical examination, vital signs, and laboratory test indicators compared to pre-administration levels;Incidence of RSV-induced LRTI requiring medical intervention (outpatient/emergency department visits or hospitalization) within 150 days post-administration (i.e., D1-D151); | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood drug concentrations and PK parameters at different time points post-administration for subjects in each dose cohort;Serum anti-RSV neutralizing antibody titers and fold increases at various time points post-administration in subjects across each dose cohort;Serum ADA positivity rate and NAb activity at different time points post-administration in subjects across dose cohorts;The hospitalization rate due to RSV within 150 days after administration (i.e., D1-D151);Incidence of AE/SAE and AESI during the study period (type, incidence rate, severity, and causality);Blood drug concentrations and PK parameters at various time points post-administration for subjects in each dose cohort;Serum anti-RSV neutralizing antibody titers and fold increases at various time points post-administration in subjects across each dose cohort;Serum ADA positivity rate and NAb activity at different time points post-administration in subjects across dose cohorts;Analysis of Respiratory Syncytial Virus Genotypes and F Protein Antigen Site Mutation Rates, and Affinity Assay for RB0026 Injection;Incidence of RSV-induced LRTI requiring medical intervention (outpatient, emergency department, or hospitalization) within 151–360 days after dosing; | — |
Countries
China
Contacts
Public ContactLuo Xiaoli / Xing Shasha
Chengdu Women and Children's Medical Center
Outcome results
None listed