Objectives: ADC189 is a novel anti-influenza virus inhibitor. In this study, we aimed to evaluate the safety and efficacy of ADC189 in outpatients with uncomplicated influenza infection. Methods: In the phase 2 trial, we assigned patients in a 2:2:1 ratio to receive either single dose 15-mg or 45mg of ADC189 or placebo. In the phase 3 part, participants were randomized in a 2:1 ratio to receive 45-mg of ADC189 or placebo. The primary endpoint was the time to alleviation of influenza symptoms in the intention-to-treat infected population. Results: In the phase 2 trial that had 150 participants, the median time for virus RNA clearance was shorter in both ADC189 groups (15-mg group, 50
[1]Shanghai Jiao Tong Univ, Ruijin Hosp, Sch Med, Dept Pulm & Crit Care Med, Shanghai, Peoples R China.
[2]Zhejiang Shuren Univ, Shulan Hangzhou Hosp, Shulan Int Med Coll, Dept Infect Dis, Hangzhou, Zhejiang, Peoples R China.
[3]Zhejiang Prov Peoples Hosp, Dept Pulm & Crit Care Med, Hangzhou, Zhejiang, Peoples R China.
[4]Liaocheng Peoples Hosp, Dept Infect Dis, Liaocheng, Shandong, Peoples R China.
[5]Nanjing Med Univ, Sir Run Run Hosp, Dept Pulm & Crit Care Med, Nanjing, Jiangsu, Peoples R China.
[6]Guangzhou Med Univ, Affiliated Hosp 1, Dept Pulm & Crit Care Med, Guangzhou, Guangdong, Peoples R China.
[7]Ningbo 2 Hosp, Dept Infect Dis, Ningbo, Zhejiang, Peoples R China.
[8]Zhejiang Univ, Affiliated Hosp 1, Sch Med, Dept Infect Dis, Hangzhou, Zhejiang, Peoples R China.
[9]Zhejiang Hosp, Dept Infect Dis, Hangzhou, Zhejiang, Peoples R China.
[10]Zhejiang Xiaoshan Hosp, Dept Pulm & Crit Care Med, Hangzhou, Zhejiang, Peoples R China.
[11]Quzhou Peoples Hosp, Dept Infect Dis, Quzhou, Zhejiang, Peoples R China.
[12]First Hosp Jiaxing, Dept Infect Dis, Jiaxiang, Zhejiang, Peoples R China.
[13]Tongji Univ, Shanghai East Hosp, Sch Med, Dept Infect Dis, Shanghai, Peoples R China.
[14]Peoples Hosp Chizhou, Dept Gen Med, Chizhou, Anhui, Peoples R China.
[15]Guangzhou Med Univ, Affiliated Hosp 3, Dept Emergency, Guangzhou, Guangdong, Peoples R China.
[16]Yixing Peoples Hosp, Dept Pulm & Crit Care Med, Yixing, Jiangsu, Peoples R China.
[17]Hunan Univ Med, Gen Hosp, Dept Infect Dis, Huaihua, Hunan, Peoples R China.
[18]Southern Med Univ, Nanfang Hosp, Dept Infect Dis, Guangzhou, Guangdong, Peoples R China.
[19]Nanyang First Peoples Hosp, Dept Pulm & Crit Care Med, Nanyang, Henan, Peoples R China.
[20]Jinan Cent Hosp, Dept Infect Dis, Jinan, Shandong, Peoples R China.
[21]Linyi Peoples Hosp, Dept Infect Dis, Linyi, Shandong, Peoples R China.
[22]Qingyuan Peoples Hosp, Dept Pulm & Crit Care Med, Qingyuan, Guangdong, Peoples R China.
[23]Shijiazhuang Municipal Hosp TCM, Dept TCM Med, Dept Pulm & Crit Care Med, Shijiazhuang, Hebei, Peoples R China.
[24]Peking Univ, Peoples Hosp, Dept Infect Dis, Beijing, Peoples R China.
[25]Peoples Hosp Changzhi, Dept Infect Dis, Changzhi, Shanxi, Peoples R China.
[26]Jiaxing Andicon Biotech Co Ltd, Jiaxing, Zhejiang, Peoples R China.
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