Status:
COMPLETED
A Clinical Study to Test the Safety, Exposure, and Pharmacodynamic Markers of CSL311 in Patients With Mild-to-moderate Asthma and in Healthy Volunteers
Lead Sponsor:
CSL Behring
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- Male or female subjects 18 to 65 years of age with diagnosis of mild-to-moderate asthma for Parts A and B. For part C healthy, male or female subjects 18 to 50 years
Exclusion
- Oral/parenteral corticosteroids or anti-interleukin-6 therapy within 6 months prior to screening, or any prohibited therapies prior to screening.
- History or presence of clinically significant hypertension or other significant cardiovascular abnormality.
- Any clinically significant abnormality on electrocardiogram at screening.
- Parasitic infestation within 6 months before screening, or travel or intention to travel to a country with a high prevalence of such infections within 1 year before screening or within 85 days after the last dose of CSL311.
- Occurrence of asthma exacerbation and/or upper/lower respiratory tract infection, or any acute infection or disease within the last 6 weeks before screening.
Key Trial Info
Start Date :
November 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2023
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT04082754
Start Date
November 28 2019
End Date
November 14 2023
Last Update
January 10 2024
Active Locations (3)
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1
Paraxel Berlin
Berlin, Germany
2
Fraunhofer-Institut für Toxikologie und Experimentelle Medizin ITEM
Hanover, Germany, 30625
3
Medicines Evaluation Unit
Manchester, United Kingdom, M23 9QZ