{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Chen G"],"funding":["Staidson (Beijing) Biopharmaceuticals"],"pagination":["663-675"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC9876408"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["12(2)"],"pubmed_abstract":["Introduction
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 ).Methods
Thirty-two enrolled participants were randomized into three single-dose cohorts (2, 4, and 8 mg"],"journal":["Infectious diseases and therapy"],"pubmed_title":["Safety, 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."],"pmcid":["PMC9876408"],"funding_grant_id":["/"],"pubmed_authors":["Wu K","Wu J","Jin T","Chen G","Li L","Li N","Dai X","Sheng G","Zhu M","Tu S","Shen Z","Tang L","Peng C"],"additional_accession":[]},"is_claimable":false,"name":"Safety, 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.","description":"Introduction
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 ).Methods
Thirty-two enrolled participants were randomized into three single-dose cohorts (2, 4, and 8 mg","dates":{"release":"2023-01-01T00:00:00Z","publication":"2023 Feb","modification":"2025-04-19T17:51:52.968Z","creation":"2025-04-19T17:51:52.968Z"},"accession":"S-EPMC9876408","cross_references":{"pubmed":["36697937"],"doi":["10.1007/s40121-023-00759-4"]}}