Trials / Completed
CompletedNCT05130970
Garadacimab Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary Fibrosis
A Randomized, Double-blind, Placebo-controlled, Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of Garadacimab in Subjects With Idiopathic Pulmonary Fibrosis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 81 (actual)
- Sponsor
- CSL Behring · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of garadacimab in subjects with idiopathic pulmonary fibrosis (IPF).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Garadacimab | Participants received garadacimab intravenous (IV) loading dose followed by 3 subcutaneous (SC) doses. |
| DRUG | Placebo | Participants received a matching placebo IV loading dose, followed by 3 SC doses. |
Timeline
- Start date
- 2022-02-03
- Primary completion
- 2024-01-02
- Completion
- 2024-01-02
- First posted
- 2021-11-23
- Last updated
- 2024-12-13
- Results posted
- 2024-12-13
Locations
47 sites across 11 countries: United States, Australia, Austria, Belgium, Canada, Denmark, Germany, Italy, Poland, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05130970. Inclusion in this directory is not an endorsement.