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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06083623
Other study ID # TNM001-301
Secondary ID CTR20232792
Status Not yet recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date October 6, 2023
Est. completion date August 31, 2026

Study information

Verified date September 2023
Source Zhuhai Trinomab Pharmaceutical Co., Ltd.
Contact Ying Wang
Phone +86 0756 7263999
Email emma.wang@trinomab.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), neutralizing antibody and antidrug antibody (ADA) response for TNM001 in infants entering their first RSV season.


Description:

This study adopts an adaptive seamless dose selection design and consists of two parts: Part 1 is a phase 2b dose ranging trial which will support to determine the dose for Part 2, the phase 3 trial. The study population includes early and mid-term preterm infants [gestational age (GA)﹤35 weeks 0 day] and late preterm infants or full-term infants (≥35 weeks 0 day GA), with or without Congenital Heart Disease (CHD) or premature infants Chronic Lung Disease (CLD). A total of approximately 2250 infants will be randomized 2:1 to receive either TNM001 or placebo. All subjects will be followed for 240 days after dosing. This study will be conducted in appropriately 50 sites in China.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 2250
Est. completion date August 31, 2026
Est. primary completion date May 31, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 0 Years to 1 Year
Eligibility Inclusion Criteria: - 1. Early and mid-term preterm infants (<35 weeks 0 day GA) and late preterm infants or full-term infants (=35 weeks 0 day GA) under 1 year of age, with or without Congenital Heart Disease (CHD) or premature infants Chronic Lung Disease (CLD),who are entering their first RSV season at the time of screening. Exclusion Criteria: - 1. Any fever (> 38.0°C) or acute illness within 7 days prior to randomization - 2. History of RSV infection or active RSV infection prior to, or at the time of, randomization - 3. Drug medication prior to randomization or expected to be treated by medicines during the study period. - 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. Prior history of a suspected or actual acute life-threatening event - 8. Known immunodeficiency including HIV, mother with HIV infection unless the child's infection has been excluded. - 9. Known allergy history of immunoglobulin products, receipt or expected to receive immunoglobulins or blood products during the study period. - 10.Receipt of RSV vaccine or mAb

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
TNM001
single dose intramuscular injection
placebo
single dose intramuscular injection

Locations

Country Name City State
China Children's Hospital Capital Institute Pediatrics Beijing Beijing
China Peking University Third Hospital Beijing Beijing
China The First People'S Hospital of Changde City Changde Hunan
China The Maternal and Child Health Hospital of Hunan Province Changsha Hunan
China The Third Xiangya Hospital of Central South University Changsha Hunan
China Xiangya Hospital Central South University Changsha Hunan
China Chengdu Women's and Children's Central Hospital Chengdu Sichuan
China West China Second University Hospital, Sichuan University Chengdu Sichuan
China Children's Hospital of Chongqing Medical University Chongqing Sichuan
China Jiangjin Central Hospital Chongqing Chongqing
China The Third Affiliated Hospital of Guangzhou Medical University Guangdong Guangdong
China Guangdong Maternal and Child Health Care Hospital Guangzhou Guangdong
China Affiliated Hospital of Guilin Medical University Guilin Guangxi
China HaiNan Women and Children's Medical Center Haikou Hainan
China Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine/Hangzhou First People's Hospital Hangzhou Zhejiang
China The Second Hospital University of South China Hengyang Hunan
China Children's Hospital Affiliated to Shandong University Jinan Shandong
China Hebei Petro China Central Hospital Langfang Hebei
China Linfen Central Hospital Linfen Shanxi
China Linfen People's Hospital Linfen Shanxi
China LiuZhou People's Hospital Liuzhou Guangxi
China Loudi Central Hospital Loudi Hunan
China Mianyang Peoples Hospital Mianyang Sichuan
China Jiangxi Maternal and Child Health Hospital Nanchang Jiangxi
China Maternity and Child Health Care of Guangxi Zhuang Autonomous Region Nanning Guangxi
China Ningbo Women&Children's Hospital Ningbo Zhejiang
China Sanmenxia Central Hospital Sanmenxia Henan
China The affiliated children'shospital fudan university Shanghai Shanghai
China The First Affiliated Hospital of Shaoyang University Shaoyang Hunan
China University of Chinese Academy of Sciense Shenzhen Hospital Shenzhen Guangdong
China The Fourth Hospital of Hebei Medical University Shijia Zhuang Hebei
China The Second Hospital of HeBei Medical University (HBMU) Shijia Zhuang Hebei
China Tangshan Maternal and Child Health Hospitaltangshan Maternal and Child Health Hospital Tangshan Hebei
China Renmin Hospital of Wuhan University Wuhan Hubei
China The Central Hospital of Wuhan Wuhan Hubei
China Xiamen maternal and Child Health Hospital Xiamen Fujian
China Xinxiang First People's Hospital Xinxiang Henan
China Yuncheng Central Hospital Yuncheng Shanxi
China Henan (Zhengzhou) Children's Hospital Zhengzhou Henan

Sponsors (1)

Lead Sponsor Collaborator
Zhuhai Trinomab Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of medically attended LRTI due to RT-PCR confirmed RSV 150 days post dose
Secondary Incidence of hospitalization due to RT-PCR confirmed RSV LRTI 150 days post dose
Secondary Occurrence of adverse events (AEs) 240 days post dose
Secondary Change in body temperature (celsius) 240 days post dose
Secondary Change in blood pressure (mmHg) 240 days post dose
Secondary Change in heart rate (beats per minute) 240 days post dose
Secondary Change in respiratory rate (breaths per min) 240 days post dose
Secondary Number of subjects with clinical significant abnormality in physical examinations 240 days post dose
Secondary Serum concentration of single dose TNM001 at pre-specified timepoints 240 days post dose
Secondary Serum level of neutralizing antibody to RSV 240 days post dose
Secondary Positive rate of anti-drug antibody (ADA) to TNM001 in serum 240 days post dose
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