A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety, Tolerability, and Efficacy of ADM03820 to Prevent Symptomatic COVID-19 in Adult Subjects

This is a Phase 2/3, randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety, tolerability, and efficacy of ADM03820 to prevent symptomatic COVID-19 in adult subjects (≥ 18 years of age).

开始日期2023-01-01

申办/合作机构

Resilience Government Services, Inc.

[+1]

NCT04592549 / Completed临床1期

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics, and Immunogenicity of ADM03820 in Adults

This is a phase 1, randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety, pharmacokinetics, and immunogenicity of ADM03820 administered as IM injections in healthy adults for the prevention of COVID-19.

开始日期2020-12-04

申办/合作机构

Resilience Government Services, Inc.

[+1]

100 项与 ADM-03820 相关的临床结果

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100 项与 ADM-03820 相关的转化医学

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100 项与 ADM-03820 相关的专利（医药）

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项与 ADM-03820 相关的文献（医药）

2022-03-01·Med (New York, N.Y.)

A combination of two human neutralizing antibodies prevents SARS-CoV-2 infection in cynomolgus macaques

Article

作者: Hoppe, Brian ; Hopkins, Svetlana A ; Collins, Laura ; House, Robert V ; Barouch, Dan H ; Nkolola, Joseph ; Andersen, Hanne ; Diamond, Michael S ; Chen, Rita E ; Cook, Anthony ; Snow, Doris M ; Hechenblaickner, Manuel ; Earnhart, Christopher G ; Hackett, Kyal ; Chandrashekar, Abishek ; Tomic, Milan T ; Nonet, Genevieve H ; Cobb, Ronald R ; Gilchuk, Pavlo ; Yu, Jingyou ; Lewis, Mark G ; Crowe, James E ; VanBlargan, Laura A ; Dorsey, Nicole M ; Slaughter, James C ; Carnahan, Robert H

BACKGROUND:

Human monoclonal antibody (mAb) treatments are promising for COVID-19 prevention or therapy. The pre-exposure prophylactic efficacy of neutralizing antibodies that are engineered with mutations to extend their persistence in human serum and the neutralizing antibody titer in serum required for protection against SARS-CoV-2 infection remain poorly characterized.

METHODS:

The Fc region of two neutralizing mAbs (COV2-2130 and COV2-2381) targeting non-overlapping epitopes on the receptor binding domain of SARS-CoV-2 spike protein was engineered to extend their persistence in humans and reduce interactions with Fc gamma receptors. We assessed protection by individual antibodies or a combination of the two antibodies (designated ADM03820) given prophylactically by an intravenous or intramuscular route in a non-human primate (NHP) model of SARS-CoV-2 infection.

FINDINGS:

Passive transfer of individual mAbs or ADM03820 conferred virological protection in the NHP respiratory tract in a dose-dependent manner, and ADM03820 potently neutralized SARS-CoV-2 variants of concern in vitro. We defined a protective serum-neutralizing antibody titer and concentration in NHPs for passively transferred human antibodies that acted by direct viral neutralization.

CONCLUSIONS:

In summary, we demonstrate that neutralizing antibodies with extended half-life and lacking Fc-mediated effector functions are efficient for pre-exposure prophylaxis of SARS-CoV-2 infection in NHPs. These results support clinical development of ADM03820 for COVID-19 prevention.

FUNDING:

This research was supported by a contract from the JPEO-CBRND (W911QY-20-9-003, 20-05); the Joint Sciences and Technology Office and Joint Program Executive Office (MCDC-16-01-002 JSTO, JPEO); a DARPA grant (HR0011-18-2-0001); an NIH grant (R01 AI157155); and the 2019 Future Insight Prize from Merck KGaA.

100 项与 ADM-03820 相关的药物交易

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