Clinical trial NCT06083623: A Trial to Evaluate the Efficacy and Safety of TNM001 for the Prevention of Lower Respiratory Tract Infection Caused by Respiratory Syncytial Virus in Infants
Official title: A Randomized, Double-blind, Placebo-controlled and Parallel Group Adaptive Phase 2b/3 Trial to Evaluate the Efficacy and Safety of TNM001 Injection for the Prevention of Lower Respiratory Tract Infection Caused by Respiratory Syncytial Virus in Infants Under One Year of Age
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Respiratory Syncytial Virus Infections
Lead sponsor: Zhuhai Trinomab Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-10-16
Enrollment: 2250
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of medically attended LRTI due to RT-PCR confirmed RSV
timeFrame: 150 days post dose
Secondary outcomes:
measure: Incidence of hospitalization due to RT-PCR confirmed RSV LRTI
timeFrame: 150 days post dose
measure: Occurrence of adverse events (AEs)
timeFrame: 240 days post dose
measure: Change in body temperature (celsius)
timeFrame: 240 days post dose
measure: Change in blood pressure (mmHg)
timeFrame: 240 days post dose
measure: Change in heart rate (beats per minute)
timeFrame: 240 days post dose
measure: Change in respiratory rate (breaths per min)
timeFrame: 240 days post dose
measure: Number of subjects with clinical significant abnormality in physical examinations
timeFrame: 240 days post dose
measure: Serum concentration of single dose TNM001 at pre-specified timepoints
timeFrame: 240 days post dose
measure: Serum level of neutralizing antibody to RSV
timeFrame: 240 days post dose
measure: Positive rate of anti-drug antibody (ADA) to TNM001 in serum
timeFrame: 240 days post dose
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Children's Hospital Capital Institute Pediatrics
state: Beijing
city: Chongqing
country: China
facility: Jiangjin Central Hospital
state: Chongqing
city: Xiamen
country: China
facility: Xiamen maternal and Child Health Hospital
state: Fujian
city: Guangdong
country: China
facility: The Third Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Maternal and Child Health Care Hospital
state: Guangdong
city: Shenzhen
country: China
facility: University of Chinese Academy of Sciense Shenzhen Hospital
state: Guangdong
city: Guilin
country: China
facility: Affiliated Hospital of Guilin Medical University
state: Guangxi
city: Liuzhou
country: China
facility: LiuZhou People's Hospital
state: Guangxi
city: Nanning
country: China
facility: Maternity and Child Health Care of Guangxi Zhuang Autonomous Region
state: Guangxi
city: Haikou
country: China
facility: HaiNan Women and Children's Medical Center
state: Hainan
city: Langfang
country: China
facility: Hebei Petro China Central Hospital
state: Hebei
city: Shijia Zhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
state: Hebei
city: Shijia Zhuang
country: China
facility: The Second Hospital of HeBei Medical University (HBMU)
state: Hebei
city: Tangshan
country: China
facility: Tangshan Maternal and Child Health Hospitaltangshan Maternal and Child Health Hospital
state: Hebei
city: Sanmenxia
country: China
facility: Sanmenxia Central Hospital
state: Henan
city: Xinxiang
country: China
facility: Xinxiang First People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan (Zhengzhou) Children's Hospital
state: Henan
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Wuhan
country: China
facility: The Central Hospital of Wuhan
state: Hubei
city: Changde
country: China
facility: The First People'S Hospital of Changde City
state: Hunan
city: Changsha
country: China
facility: The Maternal and Child Health Hospital of Hunan Province
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Hengyang
country: China
facility: The Second Hospital University of South China
state: Hunan
city: Loudi
country: China
facility: Loudi Central Hospital
state: Hunan
city: Shaoyang
country: China
facility: The First Affiliated Hospital of Shaoyang University
state: Hunan
city: Nanchang
country: China
facility: Jiangxi Maternal and Child Health Hospital
state: Jiangxi
city: Jinan
country: China
facility: Children's Hospital Affiliated to Shandong University
state: Shandong
city: Shanghai
country: China
facility: The affiliated children'shospital fudan university
state: Shanghai
city: Linfen
country: China
facility: Linfen Central Hospital
state: Shanxi
city: Linfen
country: China
facility: Linfen People's Hospital
state: Shanxi
city: Yuncheng
country: China
facility: Yuncheng Central Hospital
state: Shanxi
city: Chengdu
country: China
facility: Chengdu Women's and Children's Central Hospital
state: Sichuan
city: Chengdu
country: China
facility: West China Second University Hospital, Sichuan University
state: Sichuan
city: Chongqing
country: China
facility: Children's Hospital of Chongqing Medical University
state: Sichuan
city: Mianyang
country: China
facility: Mianyang Peoples Hospital
state: Sichuan
city: Hangzhou
country: China
facility: Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine/Hangzhou First People's Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo Women&Children's Hospital
state: Zhejiang
Study officials:
affiliation: West China Second Hospital, Sichuan University
name: Hanmin Liu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Chongqing Medical University
name: Enmei Liu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhuhai Trinomab Pharmaceutical Co., Ltd.
name: Ying Wang
role: STUDY_DIRECTOR
References: