BDB-001

The BDB-001 Study is a Phase II clinical trial evaluating the efficacy and safety of BDB-001, an investigational recombinant humanized IgG4 monoclonal antibody, for the treatment of severe and progressive COVID-19. The study explores BDB-001 as a targeted immunomodulatory therapy aimed at improving clinical outcomes in hospitalized patients.

Information

This study assesses BDB-001 administered to patients with severe and progressive COVID-19 across multiple clinical sites in Indonesia. The trial enrolled approximately 60 patients and was conducted at RSUP Persahabatan, Pasar Minggu District Hospital, and RSUD Cengkareng between July 2020 and January 2021. Outcomes include treatment efficacy, safety, and clinical improvement parameters.

Staidson Biopharmaceutical Co Ltd
Beijing Defengrei Biotechnology Co

Type of Study

Stakeholders Involved

COVID-19 Clinical Trial

Background

Severe and progressive COVID-19 is frequently associated with excessive inflammatory responses that may lead to acute respiratory distress syndrome (ARDS) and increased mortality. Complement component C5a plays a critical role in driving hyperinflammation and lung injury in severe COVID-19. BDB-001 was developed to inhibit C5a activity, with the aim of reducing inflammation, improving respiratory function, and accelerating recovery in patients with severe disease.