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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.

Trial Information
3 Sites
82 Participants
18 Years to 65 Years

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Paraxel Berlin
FraunhoferInstitut fr Toxikologie und Experimentelle Medizin ITEM
Hannover,Germany,NW10 7EW
Medicines Evaluation Unit
Manchester,United Kingdom

Study Eligibility 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
  • 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