A Phase I Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Co-administered MERS-CoV Antibodies REGN3048 and REGN3051 vs. Placebo in Healthy Adults

This is a Phase 1, first-in-human (FIH), single site, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of single ascending doses of a co-administered (1:1, w/w) combination of REGN3048 and REGN3051 mAb's, administered IV in healthy adult volunteers. Study duration of approximately 16 months. Approximately 48 evaluable subjects will be enrolled in the study, eight (8) subjects in each one of 6 sequential ascending IV dose cohorts. In each cohort, subjects will be randomized to receive mAb's REGN3048 and REGN3051 (6 subjects) or placebo (2 subjects). Primary Objective: To assess the safety and tolerability of REGN3048 and REGN3051 following co-administration of single, ascending IV doses of 1.5, 5, 15, 25, 50, and 75 mg/kg of each of the two mAb's.

开始日期2018-02-12

申办/合作机构

National Institute of Allergy & Infectious Diseases

100 项与 REGN-3051 相关的临床结果

登录后查看更多信息

100 项与 REGN-3051 相关的转化医学

登录后查看更多信息

100 项与 REGN-3051 相关的专利（医药）

登录后查看更多信息

项与 REGN-3051 相关的文献（医药）

2023-09-16·World journal of clinical cases

Comparing the efficacy of regen-cov, remdesivir, and favipiravir in reducing invasive mechanical ventilation need in hospitalized COVID-19 patients.

作者: Hassan, Ahmed Hosny ; Hegazy, Sahar Kmal ; Tharwat, Samar

BACKGROUNDCoronavirus disease 2019 (COVID-19) pandemic stimulates research works to find a solution to this crisis from starting 2020 year up to now. With ending of the 2021-year, various advances in pharmacotherapy against COVID-19 have emerged. Regarding antiviral therapy, casirivimab and imdevimab antibody combination is a type of new immunotherapy against COVID-19. Standard antiviral therapy against COVID-19 includes Remdesivir and Favipiravir.AIMTo evaluate the efficacy of antibodies cocktail (casirivimab and imdevimab) compared to standard antiviral therapy in reducing the need for invasive mechanical ventilation (IMV).METHODS265 COVID-19 polymerase chain reaction confirmed patients with indication for antiviral therapy were included in this study and were divided into 3 groups (1: 2: 2): Group A: REGN3048-3051 antibodies cocktail (casirivimab and imdevimab), group B: Remdesivir, group C: Favipiravir. The study design is a single-blind non-randomized controlled trial Mansoura University Hospital owns the study's drugs. The duration of the study was about 6 mo after ethical approval.RESULTSCasirivimab and imdevimab achieve less need for O₂ therapy and IMV, with less duration of this need than remdesivir and favipiravir.CONCLUSIONGroup A (casirivimab and imdevimab) achieve better clinical outcomes than groups B (remdesivir) and C (favipiravir) intervention groups.

2023-06-01·Journal of Clinical Virology Plus

Clinical study to compare the efficacy and safety of casirivimab & imdevimab, remdesivir, and favipravir in hospitalized COVID-19 patients

Article

作者: Hassan, Ahmed H ; Hegazy, Sahar K ; Tharwat, Samar

BackgroundCorona Virus disease - 2019 (COVID-19) disease induces scientific research to find a control to this pandemic from 2020 year up to now. Recently, various advances in pharmacotherapy against COVID-19 have emerged.ObjectivesTo compare the efficacy and safety of antibodies cocktail (casirivimab and imdevimab), Remdesivir, and Favipravir in the COVID-19 patients.Study designThis study is a single-blind non-Randomized Controlled Trial (non-RCT). The drugs of the study are prescribed by lectures on chest diseases, faculty of medicine-Mansoura University. The duration of the study is about six months after ethical approval.265 hospitalized COVID-19 patients were used to represent the COVID-19 population and were assigned into three groups in a ratio of (1:2:2) respectively, Group (A) received REGN3048-3051(Antibodies cocktail (casirivimab and imdevimab)), group (B) received remdesivir, and group (C) received favipravir.ResultsCasirivimab and imdevimab achieve less 28-day mortality rate, and less mortality at hospital discharge than Remdesivir, and Favipravir.ConclusionFrom all of these results, it is concluded that Group A (Casirivimab & imdevimab) achieves more favorable outcomes than B (Remdesivir) & C (Favipravir) intervention groups.Clinical trial registrationNCT05502081, 16/08/2022, Clinicaltrials.gov.

2022-05-16·The Journal of Infectious Diseases

Human Monoclonal Antibody Cocktail for the Treatment or Prophylaxis of Middle East Respiratory Syndrome Coronavirus

Article

作者: Hassanein, Mohamed ; Elango, Chinnasamy ; Conrad, Thomas ; Eng, Simon ; Kyratsous, Christos A ; Sumner, Giane ; Saviolakis, George A ; Frieman, Matthew ; Nakamura, Aya ; Lipsich, Leah ; Kamal, Mohamed A ; Stahl, Neil ; Kulcsar, Kirsten ; Kantrowitz, Joel ; Sivapalasingam, Sumathi ; Musser, Bret J ; Weinreich, David M ; Yancopoulos, George

AbstractBackgroundREGN3048 and REGN3051 are human monoclonal antibodies (mAb) targeting the spike glycoprotein on the Middle East respiratory syndrome coronavirus (MERS-CoV), which binds to the receptor dipeptidyl peptidase-4 (DPP4) and is necessary for infection of susceptible cells.MethodsPreclinical study: REGN3048, REGN3051 and isotype immunoglobulin G (IgG) were administered to humanized DPP4 (huDPP4) mice 1 day prior to and 1 day after infection with MERS-CoV (Jordan strain). Virus titers and lung pathology were assessed. Phase 1 study: healthy adults received the combined mAb (n = 36) or placebo (n = 12) and followed for 121 days. Six dose levels were studied. Strict safety criteria were met prior to dose escalation.ResultsPreclinical study: REGN3048 plus REGN3051, prophylactically or therapeutically, was substantially more effective for reducing viral titer, lung inflammation, and pathology in huDPP4 mice compared with control antibodies and to each antibody monotherapy. Phase 1 study: REGN3048 plus REGN3051 was well tolerated with no dose-limiting adverse events, deaths, serious adverse events, or infusion reactions. Each mAb displayed pharmacokinetics expected of human IgG1 antibodies; it was not immunogenic.ConclusionsREGN3048 and REGN3051 in combination were well tolerated. The clinical and preclinical data support further development for the treatment or prophylaxis of MERS-CoV infection.

100 项与 REGN-3051 相关的药物交易

登录后查看更多信息