NCT04082754CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 10 Jan 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 78 (actual)
- First submitted
- 3 Sept 2019
- Start date
- 28 Nov 2019
- Primary completion date
- 14 Nov 2023
- Lead sponsor
- CSL Behring
- Diseases
- Asthma
- NCT number
- NCT04082754
- EudraCT number
- 2019-001135-32
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 78
- From 28 Nov 2019 to the primary completion date, 14 Nov 2023
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Oral/parenteral corticosteroids or anti-interleukin-6 therapy within 6 months prior to screening, or any prohibited therapies prior to 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.
Other illness
- History or presence of clinically significant hypertension or other significant cardiovascular abnormality.
Other
- Any clinically significant abnormality on electrocardiogram at screening.
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Paraxel Berlin Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Fraunhofer-Institut für Toxikologie und Experimentelle Medizin ITEM Coordinator of this site? Confirm its status | Hanover | Germany | Unknown status |
| Medicines Evaluation Unit Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.