Phase I open-label study of the respiratory syncytial virus monoclonal antibody clesrovimab: Safety and tolerability in healthy Chinese participants
In China, respiratory syncytial virus (RSV) is the primary cause of acute lower respiratory tract infections (LRTIs), particularly in infants and young children. Clesrovimab is a half-life‒extended RSV neutralizing monoclonal antibody for the prevention of RSV-associated LRTIs in infants. This Phase...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Taylor & Francis Group
2025-12-01
|
| Series: | Human Vaccines & Immunotherapeutics |
| Subjects: | |
| Online Access: | https://www.tandfonline.com/doi/10.1080/21645515.2025.2516948 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850034469478596608 |
|---|---|
| author | Yulei He Fengli Zhao Xiao Yang Shasha Xing Feifeng Xi Fen Shen Lin Yang Guijun Ning Fang Sun Rui Wang Qiong Shou Rong Fu Chang Chen Anushua Sinha Xueyan Liao |
| author_facet | Yulei He Fengli Zhao Xiao Yang Shasha Xing Feifeng Xi Fen Shen Lin Yang Guijun Ning Fang Sun Rui Wang Qiong Shou Rong Fu Chang Chen Anushua Sinha Xueyan Liao |
| author_sort | Yulei He |
| collection | DOAJ |
| description | In China, respiratory syncytial virus (RSV) is the primary cause of acute lower respiratory tract infections (LRTIs), particularly in infants and young children. Clesrovimab is a half-life‒extended RSV neutralizing monoclonal antibody for the prevention of RSV-associated LRTIs in infants. This Phase I, open-label, single-dose study, evaluated the safety and tolerability of clesrovimab in Chinese participants (EudraCT 2021-000432-58). Healthy male adults, children, and infants were sequentially enrolled in one of 3 panels, each with 25 participants. All participants received a single dose of clesrovimab (105 mg dose at 100 mg/mL concentration) on Day 1 in the deltoid or thigh muscle, beginning with male adults, followed by children, then infants, and were followed up through Day 365 postdose. Clesrovimab was generally well tolerated in healthy Chinese participants. Overall, 36.0% of male adults, 76.0% of children, and 56.0% of infants experienced at least one adverse event (AE), most were considered mild to moderate. Between Days 1 and 5 postdose, 12.0% of participants reported solicited injection site AEs (all drug-related), and 12% of infants reported solicited systemic AEs. One participant in panel A reported an anaphylaxis/hypersensitivity AE of special interest (AESI) on Day 24 postdose, not considered drug-related. No rash AESI from Day 1 through Day 42 postdose, and no serious AEs, deaths, study discontinuations or drug-related pauses were reported. These findings support the inclusion of a Chinese cohort in the global Phase IIb/III trial (NCT04767373) to evaluate the efficacy and safety of clesrovimab in healthy preterm and full-term infants. |
| format | Article |
| id | doaj-art-1fcbc04089ee4d9f839784c9762296bb |
| institution | DOAJ |
| issn | 2164-5515 2164-554X |
| language | English |
| publishDate | 2025-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj-art-1fcbc04089ee4d9f839784c9762296bb2025-08-20T02:57:48ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2025-12-0121110.1080/21645515.2025.2516948Phase I open-label study of the respiratory syncytial virus monoclonal antibody clesrovimab: Safety and tolerability in healthy Chinese participantsYulei He0Fengli Zhao1Xiao Yang2Shasha Xing3Feifeng Xi4Fen Shen5Lin Yang6Guijun Ning7Fang Sun8Rui Wang9Qiong Shou10Rong Fu11Chang Chen12Anushua Sinha13Xueyan Liao14Health Management Center, Chengdu Women’s and Children’s Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, ChinaDepartment of Pediatrics, Yuncheng Central Hospital of Shanxi Province, Yuncheng, Shanxi, ChinaDepartment of Pediatrics, School of Medicine, Chengdu Women’s and Children’s Central Hospital, Chengdu, ChinaDepartment of Pediatrics, School of Medicine, Chengdu Women’s and Children’s Central Hospital, Chengdu, ChinaDepartment of Pediatrics, Yuncheng Central Hospital of Shanxi Province, Yuncheng, Shanxi, ChinaDepartment of Pediatrics, Yuncheng Central Hospital of Shanxi Province, Yuncheng, Shanxi, ChinaDepartment of Pediatrics, Yuncheng Central Hospital of Shanxi Province, Yuncheng, Shanxi, ChinaClinical Research, MSD R&D (China) Co., Ltd, Beijing, ChinaClinical Research, MSD R&D (China) Co., Ltd, Beijing, ChinaClinical Research, MSD R&D (China) Co., Ltd, Beijing, ChinaBiostatistics, MSD R&D (China) Co., Ltd, Shanghai, ChinaBiostatistics, MSD R&D (China) Co., Ltd, Shanghai, ChinaBiostatistics, MSD R&D (China) Co., Ltd, Shanghai, ChinaClinical Research, Merck & Co., Inc., Rahway, NJ, USAClinical Research, MSD R&D (China) Co., Ltd, Beijing, ChinaIn China, respiratory syncytial virus (RSV) is the primary cause of acute lower respiratory tract infections (LRTIs), particularly in infants and young children. Clesrovimab is a half-life‒extended RSV neutralizing monoclonal antibody for the prevention of RSV-associated LRTIs in infants. This Phase I, open-label, single-dose study, evaluated the safety and tolerability of clesrovimab in Chinese participants (EudraCT 2021-000432-58). Healthy male adults, children, and infants were sequentially enrolled in one of 3 panels, each with 25 participants. All participants received a single dose of clesrovimab (105 mg dose at 100 mg/mL concentration) on Day 1 in the deltoid or thigh muscle, beginning with male adults, followed by children, then infants, and were followed up through Day 365 postdose. Clesrovimab was generally well tolerated in healthy Chinese participants. Overall, 36.0% of male adults, 76.0% of children, and 56.0% of infants experienced at least one adverse event (AE), most were considered mild to moderate. Between Days 1 and 5 postdose, 12.0% of participants reported solicited injection site AEs (all drug-related), and 12% of infants reported solicited systemic AEs. One participant in panel A reported an anaphylaxis/hypersensitivity AE of special interest (AESI) on Day 24 postdose, not considered drug-related. No rash AESI from Day 1 through Day 42 postdose, and no serious AEs, deaths, study discontinuations or drug-related pauses were reported. These findings support the inclusion of a Chinese cohort in the global Phase IIb/III trial (NCT04767373) to evaluate the efficacy and safety of clesrovimab in healthy preterm and full-term infants.https://www.tandfonline.com/doi/10.1080/21645515.2025.2516948Healthy subjectsinfectious diseasemonoclonal antibodiesPhase Irespiratorysafety |
| spellingShingle | Yulei He Fengli Zhao Xiao Yang Shasha Xing Feifeng Xi Fen Shen Lin Yang Guijun Ning Fang Sun Rui Wang Qiong Shou Rong Fu Chang Chen Anushua Sinha Xueyan Liao Phase I open-label study of the respiratory syncytial virus monoclonal antibody clesrovimab: Safety and tolerability in healthy Chinese participants Human Vaccines & Immunotherapeutics Healthy subjects infectious disease monoclonal antibodies Phase I respiratory safety |
| title | Phase I open-label study of the respiratory syncytial virus monoclonal antibody clesrovimab: Safety and tolerability in healthy Chinese participants |
| title_full | Phase I open-label study of the respiratory syncytial virus monoclonal antibody clesrovimab: Safety and tolerability in healthy Chinese participants |
| title_fullStr | Phase I open-label study of the respiratory syncytial virus monoclonal antibody clesrovimab: Safety and tolerability in healthy Chinese participants |
| title_full_unstemmed | Phase I open-label study of the respiratory syncytial virus monoclonal antibody clesrovimab: Safety and tolerability in healthy Chinese participants |
| title_short | Phase I open-label study of the respiratory syncytial virus monoclonal antibody clesrovimab: Safety and tolerability in healthy Chinese participants |
| title_sort | phase i open label study of the respiratory syncytial virus monoclonal antibody clesrovimab safety and tolerability in healthy chinese participants |
| topic | Healthy subjects infectious disease monoclonal antibodies Phase I respiratory safety |
| url | https://www.tandfonline.com/doi/10.1080/21645515.2025.2516948 |
| work_keys_str_mv | AT yuleihe phaseiopenlabelstudyoftherespiratorysyncytialvirusmonoclonalantibodyclesrovimabsafetyandtolerabilityinhealthychineseparticipants AT fenglizhao phaseiopenlabelstudyoftherespiratorysyncytialvirusmonoclonalantibodyclesrovimabsafetyandtolerabilityinhealthychineseparticipants AT xiaoyang phaseiopenlabelstudyoftherespiratorysyncytialvirusmonoclonalantibodyclesrovimabsafetyandtolerabilityinhealthychineseparticipants AT shashaxing phaseiopenlabelstudyoftherespiratorysyncytialvirusmonoclonalantibodyclesrovimabsafetyandtolerabilityinhealthychineseparticipants AT feifengxi phaseiopenlabelstudyoftherespiratorysyncytialvirusmonoclonalantibodyclesrovimabsafetyandtolerabilityinhealthychineseparticipants AT fenshen phaseiopenlabelstudyoftherespiratorysyncytialvirusmonoclonalantibodyclesrovimabsafetyandtolerabilityinhealthychineseparticipants AT linyang phaseiopenlabelstudyoftherespiratorysyncytialvirusmonoclonalantibodyclesrovimabsafetyandtolerabilityinhealthychineseparticipants AT guijunning phaseiopenlabelstudyoftherespiratorysyncytialvirusmonoclonalantibodyclesrovimabsafetyandtolerabilityinhealthychineseparticipants AT fangsun phaseiopenlabelstudyoftherespiratorysyncytialvirusmonoclonalantibodyclesrovimabsafetyandtolerabilityinhealthychineseparticipants AT ruiwang phaseiopenlabelstudyoftherespiratorysyncytialvirusmonoclonalantibodyclesrovimabsafetyandtolerabilityinhealthychineseparticipants AT qiongshou phaseiopenlabelstudyoftherespiratorysyncytialvirusmonoclonalantibodyclesrovimabsafetyandtolerabilityinhealthychineseparticipants AT rongfu phaseiopenlabelstudyoftherespiratorysyncytialvirusmonoclonalantibodyclesrovimabsafetyandtolerabilityinhealthychineseparticipants AT changchen phaseiopenlabelstudyoftherespiratorysyncytialvirusmonoclonalantibodyclesrovimabsafetyandtolerabilityinhealthychineseparticipants AT anushuasinha phaseiopenlabelstudyoftherespiratorysyncytialvirusmonoclonalantibodyclesrovimabsafetyandtolerabilityinhealthychineseparticipants AT xueyanliao phaseiopenlabelstudyoftherespiratorysyncytialvirusmonoclonalantibodyclesrovimabsafetyandtolerabilityinhealthychineseparticipants |