biostudies-literatureChen GStaidson (Beijing) Biopharmaceuticals663-675https://www.ebi.ac.uk/biostudies/studies/S-EPMC9876408biostudies-literatureUnknown12(2)<h4>Introduction</h4>Severe Coronavirus Disease 2019 (COVID-19) progresses with inflammation and coagulation, due to an overactive complement system. Complement component 5a (C5a) plays a key role in the complement system to trigger a powerful "cytokine and chemokine storm" in viral infection. BDB-001, a recombinant human immunoglobulin G4 (IgG4) that specially binds to C5a, has the potential to inhibit the C5a-triggered cytokine storm in treating COVID-19 patients and other inflammation diseases. Here, we have explored its safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy adults. This trial is registered with http://www.chinadrugtrials.org.cn/(CTR20200429 ).<h4>Methods</h4>Thirty-two enrolled participants were randomized into three single-dose cohorts (2, 4, and 8 mgInfectious diseases and therapySafety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Anti-C5a Antibody BDB-001 for Severe COVID-19: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Trial in Healthy Chinese Adults.PMC9876408/Wu KWu JJin TChen GLi LLi NDai XSheng GZhu MTu SShen ZTang LPeng CfalseSafety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Anti-C5a Antibody BDB-001 for Severe COVID-19: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Trial in Healthy Chinese Adults.<h4>Introduction</h4>Severe Coronavirus Disease 2019 (COVID-19) progresses with inflammation and coagulation, due to an overactive complement system. Complement component 5a (C5a) plays a key role in the complement system to trigger a powerful "cytokine and chemokine storm" in viral infection. BDB-001, a recombinant human immunoglobulin G4 (IgG4) that specially binds to C5a, has the potential to inhibit the C5a-triggered cytokine storm in treating COVID-19 patients and other inflammation diseases. Here, we have explored its safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy adults. This trial is registered with http://www.chinadrugtrials.org.cn/(CTR20200429 ).<h4>Methods</h4>Thirty-two enrolled participants were randomized into three single-dose cohorts (2, 4, and 8 mg2023-01-01T00:00:00Z2023 Feb2025-04-19T17:51:52.968Z2025-04-19T17:51:52.968ZS-EPMC98764083669793710.1007/s40121-023-00759-4