Trials / Completed
CompletedNCT04643587
Study to Assess CSL787 in Non-cystic Fibrosis Bronchiectasis (NCFB)
A Phase 1, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Exploratory Efficacy of Nebulized CSL787 in Healthy Subjects and Subjects With Non-Cystic Fibrosis Bronchiectasis (NCFB)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 64 (actual)
- Sponsor
- CSL Behring · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This study is a prospective, multicenter, randomized, double-blind, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and exploratory efficacy of nebulized CSL787 after administrations of single (SAD) ascending doses in healthy subjects and multiple (MAD) ascending doses in subjects with NCFB.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CSL787 | Human plasma-derived polyvalent immunoglobulin G (IgG) administered via inhalation of an aerosol produced using a nebulizer |
| DRUG | Placebo | Normal saline (0.9% NaCl) |
Timeline
- Start date
- 2020-12-07
- Primary completion
- 2023-03-12
- Completion
- 2023-03-12
- First posted
- 2020-11-25
- Last updated
- 2023-12-15
Locations
3 sites across 2 countries: Germany, United Kingdom
Source: ClinicalTrials.gov record NCT04643587. Inclusion in this directory is not an endorsement.