A Phase I, first in human study of CSL311 in mild asthma and healthy volunteers
Research type
Research Study
Full title
A Phase 1, First-in-human, Multi-center, Randomized, Double-blind, Placebo-controlled, Single Ascending and Multiple Ascending Dose Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of CSL311 in Subjects with Mild-to-Moderate Asthma and in Healthy Volunteers
IRAS ID
263737
Contact name
Dave Singh
Contact email
Sponsor organisation
CSL Behring LLC
Eudract number
2019-001135-32
Duration of Study in the UK
1 years, 5 months, 22 days
Research summary
The main purpose of the study is to see how safe the study drug, CSL311, is and how well it is tolerated after different doses are administered, in patients with mild asthma. The study will also investigate how the study drug is taken up, metabolised (broken down), distributed through the body and excreted . CSL311 is a protein drug which inhibit mediators of inflammation and is intended to reduce the immune response and inflammation in the lungs.
In this study, participants will receive the study drug or placebo in the form of an intravenous infusion (drip given into a vein in the arm) over approximately 60 minutes.
This study is split into two parts:
- Part A will look at the safety, tolerability, pharmacokinetics (the levels of study drug in the blood) and the immunogenicity (to see if the body is making antibodies against the study drug) of single doses of CSL311 in people with mild asthma.
- Part B will look at the safety, tolerability, pharmacokinetics and the immunogenicity of multiple doses of CSL311 in people with mild asthma.Both parts of the study will also look at how CSL311 affects the body.
It is expected that a total of approximately 74 participants will take part in this two-part study. Approximately 42 people will participate in Part A and approximately 32 people will participate in Part B.
REC name
North East - York Research Ethics Committee
REC reference
19/NE/0097
Date of REC Opinion
6 Aug 2019
REC opinion
Further Information Favourable Opinion