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Recruiting
NCT05630573
A Study of TNM001 in Chinese Healthy Preterm and Term Infants
Conditions: Respiratory Syncytial Virus Infections
Sex: All
Ages: N/A – 1 Year
Healthy volunteers: 1
Phase: PHASE1, PHASE2
Enrollment: 30
Sponsor: Trinomab Biotech Co., Ltd.
Location: China
Summary
The purpose of this clinical trial is to evaluate the safety, tolerability and pharmacokinetics (PK) profile of TNM001 injection in healthy preterm and term infants.
The main questions it aims to answer are:the safety and tolerability of TNM001 injectionthe pharmacokinetic (PK) profile of TNM001
Eligibility Criteria
Key Inclusion Criteria:Healthy preterm infants and term infants within 1 year old of ageInfants who are in the first RSV infection season at the time of randomizationKey Exclusion Criteria:Any fever or acute illness within 7 days prior to dosingLRTI prior to randomizationReceived any anti-RSV monoclonal antibody or RSV vaccineAny other circumstances that, in the opinion of the investigator, may interfere with the assessment of the study drug or the interpretation of the study resultsThe subject is a child of the investigator or his/her subordinate study personnel or relatives or sponsor staff
Source: ClinicalTrials.gov (NCT05630573). StuddyBuddy aggregates publicly available trial information.