A Clinical Study to Test the Safety, Exposure, and Pharmacodynamic Markers of CSL311 in Patients With Mild-to-moderate Asthma and in Healthy Volunteers
2 other identifiers
interventional
78
2 countries
3
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 assess the safety and tolerability of single ascending doses (SAD) and multiple ascending doses (MAD) of CSL311.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 asthma
Started Nov 2019
Longer than P75 for phase_1 asthma
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 3, 2019
CompletedFirst Posted
Study publicly available on registry
September 9, 2019
CompletedStudy Start
First participant enrolled
November 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 14, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 14, 2023
CompletedJanuary 10, 2024
January 1, 2024
4 years
September 3, 2019
January 9, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Percentage of subjects with treatment-emergent adverse events (TEAEs) in SC single dose, single ascending doses (SAD) and multiple ascending doses (MAD - SC and IV)
After infusion or injection, up to Day 85 for Cohorts A1 to A7, Day 57 for Cohort A8, Day 114 for Cohort B1 and Day 85 for Cohorts C1 to C3
Percentage of subjects with related TEAEs in SC single dose, SAD and MAD (SC and IV)
After infusion or injection, up to Day 85 for Cohorts A1 to A7, Day 57 for Cohort A8, Day 114 for Cohort B1 and Day 85 for Cohorts C1 to C3
Percentage of subjects with TEAEs by severity in SC single dose, SAD and MAD (SC and IV)
Severity of TEAEs defined as mild, moderate, or severe
After infusion or injection, up to Day 85 for Cohorts A1 to A7, Day 57 for Cohort A8, Day 114 for Cohort B1 and Day 85 for Cohorts C1 to C3
Secondary Outcomes (28)
Maximum plasma concentration (Cmax) of CSL311 in SAD
Up to 85 days after infusion
Time to reach Cmax (tmax) of CSL311 in SAD
Up to 85 days after infusion
Area under the concentration-time curve from time 0 to the last measurable concentration (AUC0-last) of CSL311 in SAD
Up to 85 days after infusion
Area under the concentration-time curve from time 0 extrapolated to infinite time (AUC0-inf) of CSL311 in SAD
Up to 85 days after infusion
Half-life (t½) of CSL311 in SAD
Up to 85 days after infusion
- +23 more secondary outcomes
Study Arms (14)
CSL311 Cohort A1 (SAD Dose 1)
EXPERIMENTALHuman beta common receptor antagonist monoclonal antibody administered intravenously at a Single Ascending Dose (SAD)
CSL311 Cohort A2 (SAD Dose 2)
EXPERIMENTALHuman beta common receptor antagonist monoclonal antibody administered intravenously at a SAD
CSL311 Cohort A3 (SAD Dose 3)
EXPERIMENTALHuman beta common receptor antagonist monoclonal antibody administered intravenously at a SAD
CSL311 Cohort A4 (SAD Dose 4)
EXPERIMENTALHuman beta common receptor antagonist monoclonal antibody administered intravenously at a SAD
CSL311 Cohort A5 (SAD Dose 5)
EXPERIMENTALHuman beta common receptor antagonist monoclonal antibody administered intravenously at a SAD
CSL311 Cohort A6 (SAD Dose 6)
EXPERIMENTALHuman beta common receptor antagonist monoclonal antibody administered intravenously at a SAD
CSL311 Cohort A7 (SAD Dose 7)
EXPERIMENTALHuman beta common receptor antagonist monoclonal antibody administered intravenously at a SAD
CSL311 Cohort A8 (SAD Dose 8)
EXPERIMENTALHuman beta common receptor antagonist monoclonal antibody administered intravenously at a SAD
CSL311 Cohort B1 (MAD Dose 1)
EXPERIMENTALHuman beta common receptor antagonist monoclonal antibody administered intravenously at a MAD
Placebo
PLACEBO COMPARATOR0.9% sodium chloride solution administered intravenously
Placebo (2)
PLACEBO COMPARATOR0.9% sodium chloride solution administered subcutaneously
CSL311 Cohort C1 (MAD Dose 1)
EXPERIMENTALHuman beta common receptor antagonist monoclonal antibody administered subcutaneously (SC)
CSL311 Cohort C2 (MAD Dose 2)
EXPERIMENTALHuman beta common receptor antagonist monoclonal antibody administered subcutaneously
CSL311 Cohort C3 (MAD Dose 3)
EXPERIMENTALHuman beta common receptor antagonist monoclonal antibody administered subcutaneously
Interventions
Human beta common receptor antagonist monoclonal antibody
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CSL Behringlead
Study Sites (3)
Paraxel Berlin
Berlin, Germany
Fraunhofer-Institut für Toxikologie und Experimentelle Medizin ITEM
Hanover, 30625, Germany
Medicines Evaluation Unit
Manchester, M23 9QZ, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
CSL Behring
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2019
First Posted
September 9, 2019
Study Start
November 28, 2019
Primary Completion
November 14, 2023
Study Completion
November 14, 2023
Last Updated
January 10, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- IPD requests may be submitted to CSL no earlier than 12 months after publication of the results of this study via an article made available on a public website.
- Access Criteria
- Requests may only be made by systematic review groups or bona-fide researchers whose proposed use of the IPD is non-commercial in nature and has been approved by an internal review committee. An IPD request will not be considered by CSL unless the proposed research question seeks to answer a significant and unknown medical science or patient care question as determined by CSL's internal review committee. The requesting party must execute an appropriate data sharing agreement before IPD will be made available.
CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com. Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD. If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.