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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001135-32 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSL311 Cohort A1 (SAD Dose 1) | Experimental | Human beta common receptor antagonist monoclonal antibody administered intravenously at a Single Ascending Dose (SAD) |
|
| CSL311 Cohort A2 (SAD Dose 2) | Experimental | Human beta common receptor antagonist monoclonal antibody administered intravenously at a SAD |
|
| CSL311 Cohort A3 (SAD Dose 3) | Experimental | Human beta common receptor antagonist monoclonal antibody administered intravenously at a SAD |
|
| CSL311 Cohort A4 (SAD Dose 4) | Experimental | Human beta common receptor antagonist monoclonal antibody administered intravenously at a SAD |
|
| CSL311 Cohort A5 (SAD Dose 5) | Experimental | Human beta common receptor antagonist monoclonal antibody administered intravenously at a SAD |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human beta common receptor antagonist monoclonal antibody | Biological | Human beta common receptor antagonist monoclonal antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | CSL Behring | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paraxel Berlin | Berlin | Germany | ||||
| Fraunhofer-Institut für Toxikologie und Experimentelle Medizin ITEM |
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.
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.
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.
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| CSL311 Cohort A6 (SAD Dose 6) | Experimental | Human beta common receptor antagonist monoclonal antibody administered intravenously at a SAD |
|
| CSL311 Cohort A7 (SAD Dose 7) | Experimental | Human beta common receptor antagonist monoclonal antibody administered intravenously at a SAD |
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| CSL311 Cohort A8 (SAD Dose 8) | Experimental | Human beta common receptor antagonist monoclonal antibody administered intravenously at a SAD |
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| CSL311 Cohort B1 (MAD Dose 1) | Experimental | Human beta common receptor antagonist monoclonal antibody administered intravenously at a MAD |
|
| Placebo | Placebo Comparator | 0.9% sodium chloride solution administered intravenously |
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| Placebo (2) | Placebo Comparator | 0.9% sodium chloride solution administered subcutaneously |
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| CSL311 Cohort C1 (MAD Dose 1) | Experimental | Human beta common receptor antagonist monoclonal antibody administered subcutaneously (SC) |
|
| CSL311 Cohort C2 (MAD Dose 2) | Experimental | Human beta common receptor antagonist monoclonal antibody administered subcutaneously |
|
| CSL311 Cohort C3 (MAD Dose 3) | Experimental | Human beta common receptor antagonist monoclonal antibody administered subcutaneously |
|
|
| Placebo | Drug | 0.9% sodium chloride, same volume and same duration as CSL311 |
|
| 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 |
| Clearance (CL) of CSL311 in SAD | Up to 85 days after infusion |
| Volume of distribution (Vd) of CSL311 in SAD | Up to 85 days after infusion |
| Area under the concentration-time curve from time 0 to the last measurable concentration per dose of CSL311 (AUC0-last/dose) in SAD | Up to 85 days after infusion |
| Cmax/dose of CSL311 in SAD | Up to 85 days after infusion |
| AUCtau for CSL311 in MAD (SC and IV) after first dose | Up to 15 days after infusion or injection |
| AUCtau/dose for CSL311 in MAD (SC and IV) after first dose | Up to 15 days after infusion or injection |
| Cmax of CSL311 in MAD (SC and IV) after first dose | Up to 15 days after infusion or injection |
| Cmax/dose of CSL311 in MAD (SC and IV) after first dose | Dose-normalized maximum plasma concentration | Up to 15 days after infusion or injection |
| tmax of CSL311 in MAD (SC and IV) after first dose | Up to 15 days after infusion or injection |
| Cmax of CSL311 in MAD (SC and IV) after last dose | Up to 85 days (SC) and 114 days (IV) after infusion or injection |
| AUCtau for CSL311 in MAD (SC and IV) after last dose | Up to 85 days (SC) and 114 days (IV) after infusion or injection |
| Cmax/dose of CSL311 in MAD (SC and IV) after last dose | Up to 85 days (SC) and 114 days (IV) after infusion or injection |
| tmax of CSL311 in MAD (SC and IV) after last dose | Up to 85 days (SC) and 114 days (IV) after infusion or injection |
| AUCtau/dose for CSL311 in MAD (SC and IV) after last dose | Dose-normalized area under the concentration-time curve over a dosing interval | Up to 85 days (SC) and 114 days (IV) after infusion or injection |
| Half-life (t½) of CSL311 in MAD (SC and IV) after last dose | Up to 85 days (SC) and 114 days (IV) after infusion or injection |
| Clearance (CL) of CSL311 in MAD (IV) after last dose | Up to 114 days after infusion |
| Apparent Clearance (CL/F) of CSL311 in MAD (SC) after last dose | Up to 85 days after injection |
| Volume of distribution (Vd) of CSL311 in MAD (IV) after last dose | Up to 114 days after infusion |
| Apparent volume of distribution during terminal phase (Vz/F) of CSL311 in MAD (SC) after last dose | Up to 85 days after injection |
| Number of subjects with detectable anti-CSL311 antibodies in SAD and MAD (SC and IV) | After infusion or injection, up to 85 days for SAD, and up to 85 days for MAD (SC) and 114 days for MAD (IV) |
| Percentage of subjects with TEAEs of Infections and Infestations in SAD and MAD (SC and IV) by treatment (CSL311 or placebo), by causality, and by CSL311 dose level | After infusion or injection, up to 85 days for SAD, and up to 85 days for MAD (SC) and 114 days for MAD (IV) |
| Percentage of subjects with severe or life-threatening Neutropenia in SAD and MAD (SC and IV) by treatment (CSL311 or placebo), by causality, and by CSL311 dose level | After infusion or injection, up to 85 days for SAD, and up to 85 days for MAD (SC) and 114 days for MAD (IV) |
| Percentage of subjects with TEAEs of Worsening Asthma in SAD and MAD (SC and IV) by treatment (CSL311 or placebo), by causality, and by CSL311 dose level | After infusion or injection, up to 85 days for SAD, and up to 85 days for MAD (SC) and 114 days for MAD (IV) |
| Hanover |
| 30625 |
| Germany |
| Medicines Evaluation Unit | Manchester | M23 9QZ | United Kingdom |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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