[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620916":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":38,"centralContacts":43,"locations":53,"responsibleParty":69,"collaborators":31,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":31,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":31,"studyType":85,"phases":86,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":99,"whyStopped":31,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Shanghai Institute Of Biological Products","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group","EXPERIMENTAL","SIBP-A16 injection",[13],"Drug: SIBP-A16 injection",{"label":15,"type":16,"description":17,"interventionNames":18},"Positive Comparator","ACTIVE_COMPARATOR","Nirsevimab",[19],"Drug: Nirsevimab",{"label":21,"type":22,"description":23,"interventionNames":24},"Placebo","PLACEBO_COMPARATOR","SIBP-A16 buffer solution",[25],"Drug: SIBP-A16 buffer solution",[27,32,35],{"type":28,"name":11,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Strength: dose 1, dose 2 and dose 3. Single administration via intramuscular or intravenous injection.",[9],null,{"type":28,"name":17,"description":33,"armGroupLabels":34,"otherNames":31},"Participants will receive one dose of Nisibimab via intramuscular injection.",[15],{"type":28,"name":23,"description":36,"armGroupLabels":37,"otherNames":31},"Participants in the placebo group will be assigned to four dose cohorts, and they will receive one dose of Placebo via intramuscular injection.",[21],[39],{"name":40,"affiliation":41,"role":42},"Hanwen Liu","West China Second Hospital, Sichuan University","PRINCIPAL_INVESTIGATOR",[44,49],{"name":45,"role":46,"phone":47,"phoneExt":31,"email":48},"Dandan Chen, Master","CONTACT","86-021-62800991","ddchen.sh@sinopharm.com",{"name":50,"role":46,"phone":51,"phoneExt":31,"email":52},"Bin Wu, Bachelor","02162800991","wubin50@sinopharm.com",[54],{"facility":41,"status":31,"city":55,"state":56,"zip":31,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Chengdu","Sichuan","China","CN",{"type":60,"coordinates":61},"Point",[62,63],104.06667,30.66667,{"lat":63,"lon":62},[66],{"name":40,"role":46,"phone":67,"phoneExt":31,"email":68},"86-18980602109","hanmin@vip.163.com",{"type":70,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100620916","phase-1-phase-ibiia-clinical-trial-of-sibp-a16-injection-in-premature-infants-and-full-term-infants-100620916",false,"NCT07363837","Phase Ib\u002FIIa Clinical Trial of SIBP-A16 Injection in Premature Infants and Full-term Infants","A Randomized, Double-blind, Placebo\u002FPositive Control, Dose-finding Phase Ib\u002FIIa Clinical Trial Evaluating the Safety, Tolerability, and Pharmacokinetics of SIBP-A16 Injection in Premature Infants and Full-term Infants","Inclusion Criteria:\n\n* During screening, infants within 1 year of age, including premature infants (gestational age ≥29 to \\\u003C35 weeks) and full-term infants (gestational age ≥35 weeks), with underlying diseases but no other risk factors, are allowed to participate in the trial;\n* Infants with a body weight ≥3 kg at screening;\n* Infants who are entering their first RSV infection season at screening;\n* Parents\u002Flegal guardians of trial participants have signed the informed consent form;\n* Parents\u002Flegal 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;\n* Participants can complete the follow-up period, which is approximately 1 year after the administration of the study drug.\n\nExclusion Criteria:\n\n* 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;\n* Having experienced Lower Respiratory Tract Infections (LRTI) within the previous 7 days prior to randomization, or having active LRTI at the time of randomization;\n* 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;\n* Had a history of RSV infection before randomization, or had active RSV infection at the time of randomization;\n* Those who have received non-oral inactivated vaccines or component vaccines within 7 days before administration;\n* Having received a non-oral live attenuated vaccine within 30 days prior to drug administration;\n* 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;\n* 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;\n* Have previously used or are expected to receive blood products or immunoglobulin products during the trial period;\n* Known renal dysfunction or liver dysfunction;\n* Known to have chronic lung disease (CLD)\u002Fbronchopulmonary dysplasia;\n* Congenital respiratory abnormalities with clinical significance;\n* Suffering from congenital heart disease (CHD) accompanied by significant hemodynamic changes;\n* Suffering from chronic epilepsy or progressive or unstable neurological disorders;\n* 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;\n* Known immune deficiency, including infection with human immunodeficiency virus (HIV);\n* The mother is infected with HIV (unless it has been proven that the trial participant is not infected);\n* The mother received the RSV vaccine during pregnancy;\n* Have received any investigational drugs or participated in any intervention studies;\n* Any other circumstances that the researcher believes may interfere with the evaluation of the study drug or the interpretation of the study results;\n* The participants are the children of the researchers, their subordinate researchers, relatives, or staff members of the sponsor.",true,"ALL","0 Months","12 Months",{"count":83,"type":84},36,"ESTIMATED","INTERVENTIONAL",[87,88],"PHASE1","PHASE2","This trial employs a randomized, double-blind, placebo\u002Fpositive 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.",[91],"Respiratory Syncytial Virus (RSV)",[93,94,95,96,97,98],"RSV","Preliminary efficacy","Premature and term infants","Pharmacokinetics","Safety","Tolerability","NOT_YET_RECRUITING","2026-01-14",{"date":102,"type":103},"2026-01-23","ACTUAL",{"date":105,"type":84},"2026-01-15",{"date":107,"type":84},"2027-03-31",{"name":5,"class":6},1]