Phase I study, and dosing regimen selection for a pivotal COVID-19 trial of GST-HG171
This study is aimed to evaluate the safety, tolerability, and pharmacokinetics (PK), as well as to select an appropriate dosing regimen for the pivotal clinical trial of GST-HG171, an orally bioavailable, potent, and selective 3CL protease inhibitor by a randomized, double-blind, and placebo-controlled phase I trial in healthy subjects. We conducted a Ph1 study involving 78 healthy subjects to assess the safety, tolerability, and PK of single ascending doses (150-900 mg) as well as multiple ascending doses (MADs) (150 and 300 mg) of GST-HG171. Additionally, we examined the food effect and drug-drug interaction of GST-HG171...
Source: Antimicrobial Agents and Chemotherapy - December 15, 2023 Category: Microbiology Authors: Hong Zhang Jing Zhou Hong Chen John Mao Yanan Tang Wenhao Yan Tianxiang Zhang Chuanjing Li Shikui Chen Guoping Li George Zhang Yanhua Ding Li Liu Source Type: research

Phase I study, and dosing regimen selection for a pivotal COVID-19 trial of GST-HG171
This study is aimed to evaluate the safety, tolerability, and pharmacokinetics (PK), as well as to select an appropriate dosing regimen for the pivotal clinical trial of GST-HG171, an orally bioavailable, potent, and selective 3CL protease inhibitor by a randomized, double-blind, and placebo-controlled phase I trial in healthy subjects. We conducted a Ph1 study involving 78 healthy subjects to assess the safety, tolerability, and PK of single ascending doses (150-900 mg) as well as multiple ascending doses (MADs) (150 and 300 mg) of GST-HG171. Additionally, we examined the food effect and drug-drug interaction of GST-HG171...
Source: Antimicrobial Agents and Chemotherapy - December 15, 2023 Category: Microbiology Authors: Hong Zhang Jing Zhou Hong Chen John Mao Yanan Tang Wenhao Yan Tianxiang Zhang Chuanjing Li Shikui Chen Guoping Li George Zhang Yanhua Ding Li Liu Source Type: research

Phase I study, and dosing regimen selection for a pivotal COVID-19 trial of GST-HG171
This study is aimed to evaluate the safety, tolerability, and pharmacokinetics (PK), as well as to select an appropriate dosing regimen for the pivotal clinical trial of GST-HG171, an orally bioavailable, potent, and selective 3CL protease inhibitor by a randomized, double-blind, and placebo-controlled phase I trial in healthy subjects. We conducted a Ph1 study involving 78 healthy subjects to assess the safety, tolerability, and PK of single ascending doses (150-900 mg) as well as multiple ascending doses (MADs) (150 and 300 mg) of GST-HG171. Additionally, we examined the food effect and drug-drug interaction of GST-HG171...
Source: Antimicrobial Agents and Chemotherapy - December 15, 2023 Category: Microbiology Authors: Hong Zhang Jing Zhou Hong Chen John Mao Yanan Tang Wenhao Yan Tianxiang Zhang Chuanjing Li Shikui Chen Guoping Li George Zhang Yanhua Ding Li Liu Source Type: research

Oteseconazole versus fluconazole for the treatment of severe vulvovaginal candidiasis: a multicenter, randomized, double-blinded, phase 3 trial
Antimicrob Agents Chemother. 2023 Dec 14:e0077823. doi: 10.1128/aac.00778-23. Online ahead of print.ABSTRACTVulvovaginal candidiasis (VVC) is a common condition among women. Fluconazole remains the dominant treatment option for VVC. Oteseconazole is a highly selective inhibitor of fungal CYP51. This randomized, double-blinded, phase 3 trial was conducted to evaluate the efficacy and safety of oteseconazole compared with fluconazole in treating severe VVC. Female subjects presenting with vulvovaginal signs and symptoms score of ≥7 and positive Candida infection determined by potassium hydroxide test or Gram staining were ...
Source: Antimicrobial Agents and Chemotherapy - December 14, 2023 Category: Microbiology Authors: Xiaoqian Wang Lihong Chen Hongjie Ruan Zhengai Xiong Wenying Wang Jin Qiu Weihua Song Chunlian Zhang Fengxia Xue Tianhua Qin Bei Zhang Ruifang An Xiping Luo Wei Wang Songling Zhang Yunlang Cai Jiali Kang Henan Deng Shangrong Fan Manhua Cui Shijin Wang Xia Source Type: research

Pulsed dosing and extended daily dosing of oral vancomycin do not facilitate clearance of < em > Clostridioides difficile < /em > colonization in mice
Antimicrob Agents Chemother. 2023 Dec 14:e0090323. doi: 10.1128/aac.00903-23. Online ahead of print.ABSTRACTVancomycin taper and pulse regimens are commonly used to treat recurrent Clostridioides difficile infections, but the mechanism by which these regimens might reduce recurrences is unclear. Here, we used a mouse model to test the hypothesis that pulse dosing of vancomycin after a 10-day treatment course enhances clearance of C. difficile from the intestinal tract. Mice with C. difficile colonization received 10 days of once-daily oral vancomycin followed by 20 days of treatment with saline (controls), daily vancomycin...
Source: Antimicrobial Agents and Chemotherapy - December 14, 2023 Category: Microbiology Authors: Basya S Pearlmutter Matthew G Carlisle Brigid M Wilson Naseer Sangwan Curtis J Donskey Source Type: research