更新于：2024-11-01

Brii Biosciences, Inc.

私营公司|

North Carolina, United States

私营公司|

North Carolina, United States

更新于：2024-11-01

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项与 Brii Biosciences, Inc. 相关的临床试验

NCT04770467 / Withdrawn临床2期

A Phase 2, Randomized, Single-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of Human Monoclonal Antibodies, BRII-196 and BRII-198, Administered by Intravenous Infusion for the Treatment of COVID-19 Patients

This study is to evaluate the safety, efficacy and pharmacokinetics profile of human monoclonal antibodies, BRII-196 and BRII-198 compared with placebo in patients with COVID-19.

开始日期2021-02-01

申办/合作机构

Brii Biosciences, Inc.

100 项与 Brii Biosciences, Inc. 相关的临床结果

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0 项与 Brii Biosciences, Inc. 相关的专利（医药）

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项与 Brii Biosciences, Inc. 相关的文献（医药）

2023-01-01·Patient preference and adherence

Awareness of HBV Functional Cure and Attitude Toward Related Clinical Trials Among Patients with Chronic Hepatitis B in China.

Article

作者: Liu, Ying ; Duan, Shuli ; Dong, Jinling ; Ding, Yue ; Zhou, Haiyang ; Liang, Rico ; Liu, Weihong ; Duan, Zhongping

PurposeHBV functional cure is an optimal treatment goal for chronic hepatitis B (CHB) at present and numerous new drugs aiming for HBV functional cure are in development. We carried out an internet-based survey to understand the treatment status, unmet needs, awareness of HBV functional cure and attitude toward related clinical trials among CHB patients in China.Patients and MethodsAn internet-based anonymous survey was conducted on CHB patients who reside in mainland China. Determinants of awareness and attitude were identified by logistic regression models.ResultsOf the 1220 CHB patients who completed the survey questionnaire, 11.1% (135/1220) were aware of HBV functional cure and 50.2% (612/1220) answered "definitely will" to participate in related clinical trials. Participants who knew their HBsAg level (HBsAg<1500 IU/mL: OR=3.03, 95% CI: 1.87-4.92; HBsAg≥1500 IU/mL: OR=2.57, 95% CI: 1.35-4.88), who expected to achieve HBsAg loss with treatment (OR=1.63, 95% CI: 1.07-2.50) and who were dissatisfied with current treatment due to the failure of achieving HBsAg loss (OR=1.67, 95% CI: 1.10-2.53) had better awareness of HBV functional cure. Participants who had HBsAg level less than 1500 IU/mL (OR=1.45, 95% CI: 1.05-1.99), treatment with pegylated interferon alpha with or without nucleos(t)ide (OR=1.68, 95% CI: 1.11-2.53) and better awareness of HBV functional cure (OR=1.62, 95% CI: 1.01-2.61) were more likely to say "definitely will" to participate in related clinical trials.ConclusionChinese CHB patients reported a low awareness of HBV functional cure. Although CHB patients in China reported a low rate of HBV functional cure awareness, they had a high acceptance of related clinical trials.

Frontiers in Pharmacology

Randomized, placebo-controlled, single-blind phase 1 studies of the safety, tolerability, and pharmacokinetics of BRII-196 and BRII-198, SARS-CoV-2 spike-targeting monoclonal antibodies with an extended half-life in healthy adults

Article

作者: Zhang, Yao ; Yan, Li ; Zhang, Fujie ; Ma, Ji ; Zhang, Wen ; Liu, Yang ; Zhao, Dong ; Hao, Xiaohua ; Li, Chunming ; Margolis, David ; Zhang, Zheng ; Ji, Yun ; Cheng, Lin ; Zhu, Qing

Background: BRII-196 and BRII-198 are two anti-SARS-CoV-2 monoclonal neutralizing antibodies as a cocktail therapy for treating COVID-19 with a modified Fc region that extends half-life.Methods: Safety, tolerability, pharmacokinetics, and immunogenicity of BRII-196 and BRII-198 were investigated in first-in-human, placebo-controlled, single ascending dose phase 1 studies in healthy adults. 44 participants received a single intravenous infusion of single BRII-196 or BRII-198 up to 3,000 mg, or BRII-196 and BRII-198 combination up to 1500/1500 mg, or placebo and were followed up for 180 days. Primary endpoints were incidence of adverse events (AEs) and changes from pre-dose baseline in clinical assessments. Secondary endpoints included pharmacokinetics profiles of BRII-196/BRII-198 and detection of anti-drug antibodies (ADAs). Plasma neutralization activities against SARS-CoV-2 Delta live virus in comparison to post-vaccination plasma were evaluated as exploratory endpoints.Results: All infusions were well-tolerated without systemic or local infusion reactions, dose-limiting AEs, serious AEs, or deaths. Most treatment-emergent AEs were isolated asymptomatic laboratory abnormalities of grade 1-2 in severity. BRII-196 and BRII-198 displayed pharmacokinetics characteristic of Fc-engineered human IgG1 with mean terminal half-lives of 44.6–48.6 days and 72.2–83.0 days, respectively, with no evidence of interaction or significant anti-drug antibody development. Neutralizing activities against the live virus of the SARS-CoV-2 Delta variant were maintained in plasma samples taken on day 180 post-infusion.Conclusion: BRII-196 and BRII-198 are safe, well-tolerated, and suitable therapeutic or prophylactic options for SARS-CoV-2 infection.Clinical Trial Registration:ClinicalTrials.gov under identifiers NCT04479631, NCT04479644, and NCT04691180.

100 项与 Brii Biosciences, Inc. 相关的药物交易

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100 项与 Brii Biosciences, Inc. 相关的转化医学

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