single ascending dose – Communicable Diseases Research

Preclinical assessment and randomized Phase I study of CT-P63, a broadly neutralizing antibody targeting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)

Article

Published on 2022-12-012022-11-15
Journal: Emerging Microbes & Infections
[Category] COVID19(2023년), SARS, 변종, 비임상, 진단, 치료기술, 치료제,

[키워드] acute respiratory syndrome Beta Blood caused clinically Concentration coronavirus COVID-19 creatine phosphokinase CT-P63 deaths declining Delta demonstrated detectable dose double-blind evaluated groups healthy volunteer Immunity in vitro in vivo Infection Infectious virus lung monoclonal monoclonal antibody morbidity and mortality mutated variant Neutralizing Neutralizing activity neutralizing antibody neutralizing antibody. omicron pandemic parallel-group participant peaked phase Placebo placebo-controlled Preclinical prevalent Prophylactic Randomized reduced respiratory tract Safe SARS-CoV-2 SARS-CoV-2 variant SARS-CoV-2 variants of concern Serious Adverse Events significantly single ascending dose study drug TEAE titre Tolerability Transgenic mouse treated Treatment treatment-emergent adverse event vaccination variants variants of SARS-CoV-2 wild-type
[DOI] 10.1080/22221751.2022.2117094 PMC 바로가기

First-in-Human Study of Bamlanivimab in a Randomized Trial of Hospitalized Patients With COVID-19

COVID-19로 입원한 환자의 무작위 시험에서 밤라니비맙에 대한 인간 최초 연구

Randomized Controlled Trial

Published on 2021-12-012022-09-11
Journal: Clinical Pharmacology and Therapeutics
[Category] MERS, 신약개발, 임상, 진단, 치료제,

[키워드] administration adverse event adverse events analyses attachment bamlanivimab block clinical trials coronavirus disease Coronavirus disease 2019 COVID-19 Critical death dose double-blind group half-life hospitalized patient hospitalized patients human cells increases in initial lead linear monoclonal antibody Neutralizing pandemic Patient patients hospitalized pharmacokinetic Placebo placebo-controlled provided Randomized respiratory safety profile SARS-CoV-2 Secondary objectives Serious Adverse Event Serious Adverse Events Severe acute respiratory syndrome severity single ascending dose single dose Sponsor Support TEAE TEAEs Therapeutic benefit Therapeutics Tolerability treatment-emergent adverse event Trial with COVID-19
[DOI] 10.1002/cpt.2405 PMC 바로가기 [Article Type] Randomized Controlled Trial

Phase I study in healthy participants to evaluate safety, tolerability, and pharmacokinetics of inhaled nezulcitinib, a potential treatment for COVID-19

Clinical Trial

Published on 2021-11-012022-10-05
Journal: Clinical and translational science
[Category] 임상,

Safety, Virologic Efficacy, and Pharmacokinetics of CT-P59, a Neutralizing Monoclonal Antibody Against SARS-CoV-2 Spike Receptor-Binding Protein: Two Randomized, Placebo-Controlled, Phase I Studies in Healthy Individuals and Patients With Mild SARS-CoV-2 Infection

SARS-CoV-2 스파이크 수용체 결합 단백질에 대한 중화 단일클론항체 CT-P59의 안전성, 바이러스학적 효능 및 약동학: 건강한 개인 및 경증 SARS-CoV-2 환자를 대상으로 한 무작위, 위약 대조, 1상 연구 2건 전염병

Randomized Controlled Trial

Published on 2021-10-012022-09-12
Journal: Clinical therapeutics
[Category] MERS, SARS, 임상, 진단,

[키워드] Adverse adverse event AEs Against antibody Antiviral C-reactive protein cellular entry Clinical efficacy Cohort Common Terminology Criteria COVID-19 CT-P59 dose double-blind elevated end point enrolled examined exhibited headache healthy in healthy individual individual mild SARS-CoV-2 infection monoclonal monoclonal antibody Neutralizing neutralizing monoclonal antibody pathologic Patient pharmacokinetic pharmacokinetics phase Placebo placebo-controlled Pyrexia Randomized receive receiving reduce reductions in regdanvimab. reported Safety safety profile SARS-CoV-2 secondary single ascending dose spike Time to recovery Tolerability viral titer
[DOI] 10.1016/j.clinthera.2021.08.009 PMC 바로가기 [Article Type] Randomized Controlled Trial

Accelerated first-in-human clinical trial of EIDD-2801/MK-4482 (molnupiravir), a ribonucleoside analog with potent antiviral activity against SARS-CoV-2

SARS-COV-2에 대한 강력한 항 바이러스 활성을 갖는 리보 뉴 클레오 사이드 유사체 인 EIDD-2801/MK-4482 (Molnupiravir)의 최초 인간 임상 시험의 가속화 된 인간 임상 시험.

Randomized Controlled Trial

Published on 2021-08-232022-08-13
Journal: Trials
[Category] MERS, 임상, 치료제,

[키워드] accelerated Accelerated start-up acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus 2 administration Antiviral antiviral activity antiviral agent approval causative agent Clinical data clinical trial Cohort cohorts collaboration Complete completion contract research organization coronavirus coronavirus disease Coronavirus disease 2019 COVID-19 CRO daily dose described dose Dose escalation Dosing double-blind drug eight Escalation ethics committee fasted or fed state FDA FIH FIH study followed by food food-effect global pandemic healthy volunteer healthy volunteers initial initiated MAD MAD cohort MAD cohorts Medicine Medicines Medicines and Healthcare products Regulatory Agency MHRA molnupiravir multiple ascending dose Painter pharmacokinetic Phase 2 phase 2 dosing Phase 2 study phase 2/3 Phase I Placebo profile protocol Randomized REC receive receiving Regulatory Regulatory Authorities regulatory authority Research Ethics Research Ethics Committee respiratory Ribonucleoside analog SAD cohort Safe SARS-CoV-2 sequence Seven severe acute respiratory syndrome Coronavirus single ascending dose Sponsor subject submission supported timelines Tolerability United Kingdom US Food and Drug Administration were dosed working
[DOI] 10.1186/s13063-021-05538-5 PMC 바로가기 [Article Type] Randomized Controlled Trial