Trials / Completed
CompletedNCT04082754
A Clinical Study to Test the Safety, Exposure, and Pharmacodynamic Markers of CSL311 in Patients With Mild-to-moderate Asthma and in Healthy Volunteers
A Clinical Study to Test the Safety, Exposure, and Pharmacodynamic Markers of CSL311 in Subjects With Mild-to-moderate Asthma and in Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 78 (actual)
- Sponsor
- CSL Behring · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
This is a phase 1, first-in-human (FIH), multi-center, randomized, double-blind, placebo-controlled study of CSL311 in patients with mild-to-moderate asthma. The primary objective of this study is to assess the safety and tolerability of single ascending doses (SAD) and multiple ascending doses (MAD) of CSL311.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Human beta common receptor antagonist monoclonal antibody | Human beta common receptor antagonist monoclonal antibody |
| DRUG | Placebo | 0.9% sodium chloride, same volume and same duration as CSL311 |
Timeline
- Start date
- 2019-11-28
- Primary completion
- 2023-11-14
- Completion
- 2023-11-14
- First posted
- 2019-09-09
- Last updated
- 2024-01-10
Locations
3 sites across 2 countries: Germany, United Kingdom
Source: ClinicalTrials.gov record NCT04082754. Inclusion in this directory is not an endorsement.