Asthma

A Clinical Study to Test the Safety, Exposure, and Pharmacodynamic Markers of CSL311 in Patients With Mild-to-moderate Asthma and in Healthy Volunteers

NCT04082754 | PHASE 1 | INTERVENTIONAL

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.

3 Sites

78 Participants

Recruiting

18 Years to 65 Years

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SUBMIT

Paraxel Berlin

Berlin,Germany

FraunhoferInstitut fr Toxikologie und Experimentelle Medizin ITEM

Hannover,Germany,30625

Medicines Evaluation Unit

Manchester,United Kingdom,M239QZ

Study Eligibility Criteria

Inclusion Criteria

* 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 Criteria

* 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.

Additional Studies

Additional studies can be found at ClinicalTrials.gov