{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,4]],"date-time":"2026-08-04T02:12:58Z","timestamp":1785809578129,"version":"3.56.0"},"reference-count":33,"publisher":"MDPI AG","issue":"1","license":[{"start":{"date-parts":[[2024,12,31]],"date-time":"2024-12-31T00:00:00Z","timestamp":1735603200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Sinovac Life Sciences Co., Ltd."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceutics"],"abstract":"<jats:p>Background: A broad-spectrum anti-SARS-CoV-2 monoclonal antibody (mAb), SA55, is highly effective against SARS-CoV-2 variants. This trial aimed at demonstrating the safety, tolerability, local drug retention and neutralizing activity, systemic exposure level, and immunogenicity of the SA55 nasal spray in healthy individuals. Methods: This phase I, dose-escalation clinical trial combined an open-label design with a randomized, controlled, double-blind design. Healthy participants aged 18\u201365 years were enrolled and received a single dose of the SA55 nasal spray (1 mg or 2 mg) or multiple doses of SA55 nasal spray\/placebo for 7 days (1 or 2 mg\/dose, 3 or 6 doses\/day). Safety monitoring was conducted throughout the study. Nasal swabs and venous blood samples were collected to analyze local drug concentration\/neutralization, systemic exposure, and immunogenicity. Results: From 2 June to 11 August 2023, 80 participants were enrolled and received study intervention. The severity of adverse reactions (ADRs) reported during the study was mild in all cases, and all ADRs were laboratory test abnormalities without corresponding symptoms or vital signs. A total of 9 ADRs were reported, of which all were mild in severity. Overall ADR incidence rate was 16.67% (8\/48) in single-dose groups and 4.17% (1\/24) in multiple-dose groups. The nasal local drug concentration and neutralizing activity were generally stable within 4\u20138 h, with favorable neutralization activity against Omicron BF.7 and XBB strains. Conclusions: This study demonstrated favorable safety and tolerability of the SA55 nasal spray in healthy volunteers, exhibited satisfactory neutralizing activity against Omicron variants intranasally, and indicated low systemic toxicity risk.<\/jats:p>","DOI":"10.3390\/pharmaceutics17010043","type":"journal-article","created":{"date-parts":[[2024,12,31]],"date-time":"2024-12-31T13:26:25Z","timestamp":1735651585000},"page":"43","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Safety and Intranasal Retention of a Broad-Spectrum Anti-SARS-CoV-2 Monoclonal Antibody SA55 Nasal Spray in Healthy Volunteers: A Phase I Clinical Trial"],"prefix":"10.3390","volume":"17","author":[{"given":"Chaoying","family":"Hu","sequence":"first","affiliation":[{"name":"Phase I Clinical Trial Unit, Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yibo","family":"Zhou","sequence":"additional","affiliation":[{"name":"Phase I Clinical Trial Unit, Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5309-7681","authenticated-orcid":false,"given":"Xing","family":"Meng","sequence":"additional","affiliation":[{"name":"Clinical Research and Development Center, Sinovac Biotech Co., Ltd., Beijing 100085, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9216-4699","authenticated-orcid":false,"given":"Jianhua","family":"Li","sequence":"additional","affiliation":[{"name":"Zhejiang Key Laboratory of Public Health Detection and Pathogenesis Research, Hangzhou 310051, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jinxia","family":"Chen","sequence":"additional","affiliation":[{"name":"Clinical Research and Development Center, Sinovac Life Sciences Co., Ltd., Beijing 102601, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhifang","family":"Ying","sequence":"additional","affiliation":[{"name":"Respiratory Virus Vaccine, National Institutes for Food and Drug Control, Beijing 100061, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaoliang Sunney","family":"Xie","sequence":"additional","affiliation":[{"name":"Biomedical Pioneering Innovation Center (BIOPIC), Peking University, Beijing 100871, China"},{"name":"Changping Laboratory, Beijing 102206, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yaling","family":"Hu","sequence":"additional","affiliation":[{"name":"Clinical Research and Development Center, Sinovac Life Sciences Co., Ltd., Beijing 102601, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yunlong","family":"Cao","sequence":"additional","affiliation":[{"name":"Biomedical Pioneering Innovation Center (BIOPIC), Peking University, Beijing 100871, China"},{"name":"Changping Laboratory, Beijing 102206, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ronghua","family":"Jin","sequence":"additional","affiliation":[{"name":"Phase I Clinical Trial Unit, Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2024,12,31]]},"reference":[{"key":"ref_1","unstructured":"WHO (2020, January 30). 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