A Sudy to Evaluate the Efficacy and Safety of TNM001 in High-risk Infants

Launched by ZHUHAI TRINOMAB PHARMACEUTICAL CO., LTD. · Nov 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called TNM001 for high-risk infants who may get sick from Respiratory Syncytial Virus (RSV). RSV is a common virus that can cause serious breathing problems in young children, especially those under one year old. In this study, about 201 infants will be divided into two groups: one will receive TNM001, while the other will receive a placebo, which is a treatment that looks the same but has no active medicine in it. The infants will be monitored for 270 days to see how well the treatment works and if it is safe.

To be eligible for this study, infants must be under one year old and at high risk for RSV, entering their first RSV season. Their families must be able to follow the study's requirements and attend follow-up visits. However, infants with certain health issues, like a recent fever, a history of RSV infection, or those currently in the hospital, cannot participate. It's important for families to know that this trial is not yet recruiting participants, and it will take place at around 20 locations in China.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1.High risk infants under 1 year of age who are entering their first RSV season at the time of screening.
• • 2.Subject's legal representative(s) is(are) able to understand and comply with the requirements and procedures of the protocol,including scheduled visits and sample collection.
• • 3.Subject is available to complete the follow-up period.
• Exclusion Criteria:
• • 1. Any fever (\> 38.0°C) or acute illness within 7 days prior to randomization
• • 2. History of RSV infection
• • 3. Being hospitalized at the time of randomization
• • 4. Currently receiving or expected to receive immunosuppressive therapy during the study period.
• • 5. Renal impairment or hepatic dysfunction
• • 6. Nervous system disease or neuromuscular disease
• • 7. Known immunodeficiency including HIV, mother with HIV infection unless the child's infection has been excluded.
• • 8. Known allergy history of immunoglobulin products, receipt or expected to receive immunoglobulins or blood products during the study period.
• • 9.Receipt of RSV vaccine or mAb
• • 10.Receiving blood products before randomization