Respiratory Syncytial Virus Infections
Conditions
Brief 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 injection * the pharmacokinetic (PK) profile of TNM001
Detailed description
This phase Ib/IIa study is designed to assess the safety, tolerability, and pharmacokinetics (PK) profile TNM001 in healthy preterm and term infants. This study will also compare the incidence of Respiratory Syncytial Virus（RSV） infection between different doses of TNM001 and placebo, which will be used to select the dose to be studied in the later phase of clinical trials of TNM001. Approximately 30 subjects will be randomized and will be dosed once on Day 1 and followed up until Day 151. Around 6 investigational study centres participate in the study.
Interventions
BIOLOGICALTNM001
intramuscular injection
BIOLOGICALPlacebo
intramuscular injection
Sponsors
Zhuhai Trinomab Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: 1. Healthy preterm infants and term infants within 1 year old of age 2. Infants who are in the first RSV infection season at the time of randomization Key
Exclusion criteria
1. Any fever or acute illness within 7 days prior to dosing 2. LRTI prior to randomization 3. Received any anti-RSV monoclonal antibody or RSV vaccine 4. Any other circumstances that, in the opinion of the investigator, may interfere with the assessment of the study drug or the interpretation of the study results 5. The subject is a child of the investigator or his/her subordinate study personnel or relatives or sponsor staff
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of TNM001 Injection | 150 days post dose | Type and incidence of adverse events and serious adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of TNM001 | 150 days post dose | The pharmacokinetic (PK) parameter AUC (0-infinity) will be estimated based on the serum concentrations of TNM001 |
| Maximum Observed Serum Concentration (Cmax) of TNM001 | 150 days post dose | The Cmax is the maximum observed serum concentration of TNM001 |
| Serum anti-RSV neutralizing antibodies titer levels in each dose cohort | 150 days post dose | To summarize the proportion of subjects with severalfold increase after dosing compared to the predose (baseline) |
| Anti-drug antibody (ADA) positive rate of TNM001 | 150 days post dose | The evaluation indicator of immunogenicity is the ADA positive rate in subjects |
| Terminal Elimination Half Life (t1/2) of TNM001 | 150 days post dose | Terminal phase elimination half-life (t1/2) is the time required for half of the drug to be eliminated from the serum |
Other
| Measure | Time frame | Description |
|---|---|---|
| Lower respiratory tract infection(LRTI) | 150 days post dose | The incidence of LRTI |
Countries
China
Outcome results
None listed