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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-002684-66 | EudraCT Number |
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This study is a prospective, multicenter, randomized, double-blind, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and exploratory efficacy of nebulized CSL787 after administrations of single (SAD) ascending doses in healthy subjects and multiple (MAD) ascending doses in subjects with NCFB.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSL787 (SAD dose 1) | Experimental | Inhalation by mouth of a nebulized aerosol in healthy subjects |
|
| CSL787 (SAD dose 2) | Experimental | Inhalation by mouth of a nebulized aerosol in healthy subjects |
|
| CSL787 (SAD dose 3) | Experimental | Inhalation by mouth of a nebulized aerosol in healthy subjects |
|
| CSL787 (SAD dose 4) | Experimental | Inhalation by mouth of a nebulized aerosol in healthy subjects |
|
| CSL787 (MAD dose 1) | Experimental | Inhalation by mouth of a nebulized aerosol in NCFB subjects |
|
| CSL787 (MAD dose 2) | Experimental | Inhalation by mouth of a nebulized aerosol in NCFB subjects |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CSL787 | Biological | Human plasma-derived polyvalent immunoglobulin G (IgG) administered via inhalation of an aerosol produced using a nebulizer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with treatment emergent adverse events (TEAEs) - overall, severity and causality | Up to 8 days (healthy volunteers); Up to 21 days (NCFB patients) | |
| Percent of subjects with TEAEs - overall, severity and causality | Up to 8 days (healthy volunteers); Up to 21 days (NCFB patients) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax) of CSL787 in sputum and serum in healthy subjects | Up to 8 days from inhalation | |
| Time of maximum concentration (Tmax) of CSL787 in sputum and serum in healthy subjects | Up to 8 days from inhalation |
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Inclusion Criteria:
For Part A (SAD) Only:
For Part B (MAD) Only:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | CSL Behring | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IKF Pneumologie Institute | Frankfurt | Germany | ||||
| Medicines Evaluation Unit (MEU) |
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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| CSL787 (MAD dose 3) | Experimental | Inhalation by mouth of a nebulized aerosol in NCFB subjects |
|
| Placebo | Placebo Comparator | Inhalation by mouth of a nebulized aerosol |
|
| Placebo | Drug | Normal saline (0.9% NaCl) |
|
| Area under the concentration-time curve from time 0 to 24 hours (AUC0-24h) of CSL787 in sputum and serum in healthy subjects | Up to 8 days from inhalation |
| Area under the concentration-time curve from time 0 to last quantifiable time point (AUC0-last) of CSL787 in sputum and serum in healthy subjects | Up to 8 days from inhalation |
| Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) of CSL787 in sputum and serum in healthy subjects | Up to 8 days from inhalation |
| Apparent total clearance of the drug (CL/F) of CSL787 in sputum and serum in healthy subjects | Up to 8 days from inhalation |
| Apparent volume of distribution during the elimination phase (V/F) of CSL787 in sputum and serum in healthy subjects | Up to 8 days from inhalation |
| Terminal elimination half-life (T1/2) of CSL787 in sputum and serum in healthy subjects | Up to 8 days from inhalation |
| Cmax of CSL787 in sputum and serum of NCFB subjects | On Day 1, after dosing |
| Tmax of CSL787 in sputum and serum of NCFB subjects | On Day 1, after dosing |
| Ctrough of CSL787 in sputum and serum of NCFB subjects | On Day 1, after dosing |
| AUCtau of CSL787 in sputum and serum of NCFB subjects | On Day 1, after dosing |
| Cmax of CSL787 in sputum and serum of NCFB subjects | On Day 14, after last dose |
| Tmax of CSL787 in sputum and serum of NCFB subjects | On Day 14, after last dose |
| Ctrough of CSL787 in sputum and serum of NCFB subjects | On Day 14, after last dose |
| AUCtau of CSL787 in sputum and serum of NCFB subjects | On Day 14, after last dose |
| T1/2 of CSL787 in sputum and serum of NCFB subjects | On Day 14, after last dose |
| CL/F of CSL787 in sputum and serum of NCFB subjects | On Day 14, after last dose |
| V/F of CSL787 in sputum and serum of NCFB subjects | On Day 14, after last dose |
| Accumulation Ratio (AR) for Cmax of CSL787 in sputum and serum of NCFB subjects | On Day 14, after last dose |
| AR for Ctrough of CSL787 in sputum and serum of NCFB subjects | On Day 14, after last dose |
| AR for AUCtau of CSL787 in sputum and serum of NCFB subjects | On Day 14, after last dose |
| Manchester |
| England |
| M23 9QZ |
| United Kingdom |
| Celerion | Belfast | Northern Ireland | BT9 6AD | United Kingdom |