Hu Chaoying, Zhou Yibo, Meng Xing, Li Jianhua, Chen Jinxia, Ying Zhifang, Xie Xiaoliang Sunney, Hu Yaling, Cao Yunlong, Jin Ronghua
Phase I Clinical Trial Unit, Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China.
Clinical Research and Development Center, Sinovac Biotech Co., Ltd., Beijing 100085, China.
Pharmaceutics. 2024 Dec 31;17(1):43. doi: 10.3390/pharmaceutics17010043.
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.
This phase I, dose-escalation clinical trial combined an open-label design with a randomized, controlled, double-blind design. Healthy participants aged 18-65 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.
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 4-8 h, with favorable neutralization activity against Omicron BF.7 and XBB strains.
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.
一种广谱抗SARS-CoV-2单克隆抗体（mAb）SA55对SARS-CoV-2变体具有高效性。本试验旨在证明SA55鼻喷雾剂在健康个体中的安全性、耐受性、局部药物留存和中和活性、全身暴露水平及免疫原性。
本I期剂量递增临床试验采用开放标签设计与随机、对照、双盲设计相结合。纳入18至65岁的健康参与者，给予单剂量SA55鼻喷雾剂（1毫克或2毫克）或多剂量SA55鼻喷雾剂/安慰剂，持续7天（1或2毫克/剂量，3或6剂量/天）。在整个研究过程中进行安全性监测。采集鼻拭子和静脉血样本，以分析局部药物浓度/中和作用、全身暴露情况及免疫原性。
2023年6月2日至8月11日，80名参与者入组并接受了研究干预。研究期间报告的不良反应（ADR）严重程度均为轻度，所有ADR均为实验室检查异常，无相应症状或生命体征。共报告9例ADR，均为轻度严重程度。单剂量组的总体ADR发生率为16.67%（8/48），多剂量组为4.17%（1/24）。鼻局部药物浓度和中和活性在4至8小时内通常保持稳定，对奥密克戎BF.7和XBB毒株具有良好的中和活性。
本研究证明了SA55鼻喷雾剂在健康志愿者中具有良好的安全性和耐受性，鼻内对奥密克戎变体表现出令人满意的中和活性，且全身毒性风险较低。
