The Journal of infection · 2025
Oral ADC189 for adults and adolescents with uncomplicated influenza.
СтатьяРандомизированное исследованиеКлиническое исследование II фазыКлиническое исследование III фазыНазвание и аннотация: Перевод в очереди
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Zhao Jingya, Sheng Guoping, Lyu Yingqi, Sun Yilan, Wang Sikui, Chen Xiaolin, Ye Feng, Chen Lin, Xu Xiaowei, Wang Hong, Wu Bin, Peng Chunxian, Deng Min, Qu Lihong, Jiang Xuehong, Hu Junyan, Feng Yan, Li Yongzhong, Peng Jie, Li Weiyang, Shao Lei, Gao Feng, Tian Dongbo, Tan Jie, Zheng Huanwei, Chen Meifang, Wu Hong, Zhu Xiaoyun, Zhou Min, Qu Jieming
Аннотация
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 45-mg 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, 50·7 h; 45 mg-group, 45·8 h) compared to the placebo group (73·4 h; p=0·69 and 0·016, respectively). 617 participants were enrolled in the phase 3 trial. The median time to symptom alleviation was 50·0 h (95% CI, 44·6 to 59·3) with ADC189, as compared with 68·1 h (95% CI, 62·8 to 84·4) with placebo (p<0·0001). By 1 day after initiation, the decrease in viral load from baseline was greater in the ADC189 group than in the placebo group (2·316 and 1·049 log10 virus copies per milliliter, respectively). Most adverse events were mild or moderate.
CONCLUSIONS: A single-dose ADC189 shorten the time to the resolution of symptoms among adults and adolescents with uncomplicated influenza, without evident safety concerns. (Funded by Jiaxing AnDiCon Biotech Co., Ltd, Zhejiang, China; ChiCTR number, 20230137, and ClinicalTrials. gov number, NCT06342921.).
METHODS: In the phase 2 trial, we assigned patients in a 2:2:1 ratio to receive either single dose 15-mg or 45-mg 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, 50·7 h; 45 mg-group, 45·8 h) compared to the placebo group (73·4 h; p=0·69 and 0·016, respectively). 617 participants were enrolled in the phase 3 trial. The median time to symptom alleviation was 50·0 h (95% CI, 44·6 to 59·3) with ADC189, as compared with 68·1 h (95% CI, 62·8 to 84·4) with placebo (p<0·0001). By 1 day after initiation, the decrease in viral load from baseline was greater in the ADC189 group than in the placebo group (2·316 and 1·049 log10 virus copies per milliliter, respectively). Most adverse events were mild or moderate.
CONCLUSIONS: A single-dose ADC189 shorten the time to the resolution of symptoms among adults and adolescents with uncomplicated influenza, without evident safety concerns. (Funded by Jiaxing AnDiCon Biotech Co., Ltd, Zhejiang, China; ChiCTR number, 20230137, and ClinicalTrials. gov number, NCT06342921.).