CSL312 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
85特発性間質性肺炎2

85. 特発性間質性肺炎


臨床試験数 : 627 薬物数 : 443 - (DrugBank : 120) / 標的遺伝子数 : 99 - 標的パスウェイ数 : 212
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PhaseCountries
1EUCTR2021-003162-12-DK
(EUCTR)
21/04/202210/12/2021CSL312 Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary FibrosisA Randomized, Double-blind, Placebo-controlled, Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of CSL312 in Subjects with Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Factor XIIa antagonist monoclonal antibody
Product Code: CSL312 Garadacimab
INN or Proposed INN: FXIIa inhibitor monoclonal antibody
Other descriptive name: Garadacimab
CSL Behring LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2United States;Czechia;Spain;Ukraine;Lithuania;Austria;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Poland;Denmark;Australia;Norway;Germany;Latvia;Netherlands;Sweden
2NCT05130970
(ClinicalTrials.gov)
January 27, 202212/11/2021CSL312 Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary FibrosisA Randomized, Double-blind, Placebo-controlled, Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of CSL312 in Subjects With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: CSL312;Drug: PlaceboCSL BehringNULLRecruiting40 YearsN/AAll80Phase 2United States;Australia;Austria;Belgium;Canada;Denmark;Germany;Poland;Spain;United Kingdom