AsthmaPhase 1NCT04082754
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 Phase 1 study testing Human beta common receptor antagonist monoclonal antibody in people with Asthma, run by CSL Behring at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Human beta common receptor antagonist monoclonal antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 28 Nov 2019to 14 Nov 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
Paraxel Berlin
Berlin
Fraunhofer-Institut für Toxikologie und Experimentelle Medizin ITEM
Hanover, 30625
About this study
Official title: A Clinical Study to Test the Safety, Exposure, and Pharmacodynamic Markers of CSL311 in Subjects With Mild-to-moderate Asthma and in Healthy Volunteers
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.
- Conditions
- Asthma
- Being tested
- Human beta common receptor antagonist monoclonal antibody, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human beta common receptor antagonist monoclonal antibodyBiological
Also called CSL311
Human beta common receptor antagonist monoclonal antibody
PlaceboDrug
0.9% sodium chloride, same volume and same duration as CSL311
| Study group | Role | What they receive |
|---|---|---|
| CSL311 Cohort A1 (SAD Dose 1) | Experimental | Human beta common receptor antagonist monoclonal antibody administered intravenously at a Single Ascending Dose (SAD) Receives: Biological: Human beta common receptor antagonist monoclonal antibody |
| CSL311 Cohort A2 (SAD Dose 2) | Experimental | Human beta common receptor antagonist monoclonal antibody administered intravenously at a SAD Receives: Biological: Human beta common receptor antagonist monoclonal antibody |
| CSL311 Cohort A3 (SAD Dose 3) | Experimental | Human beta common receptor antagonist monoclonal antibody administered intravenously at a SAD Receives: Biological: Human beta common receptor antagonist monoclonal antibody |
| CSL311 Cohort A4 (SAD Dose 4) | Experimental | Human beta common receptor antagonist monoclonal antibody administered intravenously at a SAD Receives: Biological: Human beta common receptor antagonist monoclonal antibody |
| CSL311 Cohort A5 (SAD Dose 5) | Experimental | Human beta common receptor antagonist monoclonal antibody administered intravenously at a SAD Receives: Biological: Human beta common receptor antagonist monoclonal antibody |
| CSL311 Cohort A6 (SAD Dose 6) | Experimental | Human beta common receptor antagonist monoclonal antibody administered intravenously at a SAD Receives: Biological: Human beta common receptor antagonist monoclonal antibody |
| CSL311 Cohort A7 (SAD Dose 7) | Experimental | Human beta common receptor antagonist monoclonal antibody administered intravenously at a SAD Receives: Biological: Human beta common receptor antagonist monoclonal antibody |
| CSL311 Cohort A8 (SAD Dose 8) | Experimental | Human beta common receptor antagonist monoclonal antibody administered intravenously at a SAD Receives: Biological: Human beta common receptor antagonist monoclonal antibody |
| CSL311 Cohort B1 (MAD Dose 1) | Experimental | Human beta common receptor antagonist monoclonal antibody administered intravenously at a MAD Receives: Biological: Human beta common receptor antagonist monoclonal antibody |
| Placebo | Placebo comparator | 0.9% sodium chloride solution administered intravenously Receives: Drug: Placebo |
| Placebo (2) | Placebo comparator | 0.9% sodium chloride solution administered subcutaneously Receives: Drug: Placebo |
| CSL311 Cohort C1 (MAD Dose 1) | Experimental | Human beta common receptor antagonist monoclonal antibody administered subcutaneously (SC) Receives: Biological: Human beta common receptor antagonist monoclonal antibody |
| CSL311 Cohort C2 (MAD Dose 2) | Experimental | Human beta common receptor antagonist monoclonal antibody administered subcutaneously Receives: Biological: Human beta common receptor antagonist monoclonal antibody |
| CSL311 Cohort C3 (MAD Dose 3) | Experimental | Human beta common receptor antagonist monoclonal antibody administered subcutaneously Receives: Biological: Human beta common receptor antagonist monoclonal antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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
Measured: 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
Measured: Up to 85 days after infusion
Time to reach Cmax (tmax) of CSL311 in SAD
Measured: 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
Measured: 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
Measured: Up to 85 days after infusion
Half-life (t½) of CSL311 in SAD
Measured: Up to 85 days after infusion
Clearance (CL) of CSL311 in SAD
Measured: Up to 85 days after infusion
Volume of distribution (Vd) of CSL311 in SAD
Measured: 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
Measured: Up to 85 days after infusion
Cmax/dose of CSL311 in SAD
Measured: Up to 85 days after infusion
AUCtau for CSL311 in MAD (SC and IV) after first dose
Measured: Up to 15 days after infusion or injection
AUCtau/dose for CSL311 in MAD (SC and IV) after first dose
Measured: Up to 15 days after infusion or injection
Cmax of CSL311 in MAD (SC and IV) after first dose
Measured: 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
Measured: Up to 15 days after infusion or injection
tmax of CSL311 in MAD (SC and IV) after first dose
Measured: Up to 15 days after infusion or injection
Cmax of CSL311 in MAD (SC and IV) after last dose
Measured: Up to 85 days (SC) and 114 days (IV) after infusion or injection
AUCtau for CSL311 in MAD (SC and IV) after last dose
Measured: 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
Measured: Up to 85 days (SC) and 114 days (IV) after infusion or injection
tmax of CSL311 in MAD (SC and IV) after last dose
Measured: 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
Measured: 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
Measured: Up to 85 days (SC) and 114 days (IV) after infusion or injection
Clearance (CL) of CSL311 in MAD (IV) after last dose
Measured: Up to 114 days after infusion
Apparent Clearance (CL/F) of CSL311 in MAD (SC) after last dose
Measured: Up to 85 days after injection
Volume of distribution (Vd) of CSL311 in MAD (IV) after last dose
Measured: Up to 114 days after infusion
Apparent volume of distribution during terminal phase (Vz/F) of CSL311 in MAD (SC) after last dose
Measured: Up to 85 days after injection
Number of subjects with detectable anti-CSL311 antibodies in SAD and MAD (SC and IV)
Measured: 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
Measured: 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
Measured: 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
Measured: After infusion or injection, up to 85 days for SAD, and up to 85 days for MAD (SC) and 114 days for MAD (IV)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start28 Nov 2019
- Primary completion14 Nov 2023
- Study completion14 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by CSL BehringThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, CSL Behring
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082754
- Sponsor's protocol ID
- CSL311_1001
- Other IDs
- 2019-001135-32, 2019
- Status last verified
- Jan 2024
- First submitted
- 3 Sep 2019
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Test the Safety, Exposure, and Pharmacodynamic Markers of CSL311 in Subjects With Mild-to-moderate Asthma and in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04082754
- Acronym / sponsor ID
- CSL311_1001
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2019 (actual)
- Primary completion
- 14 Nov 2023 (actual)
- Study completion
- 14 Nov 2023 (actual)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| CSL311 Cohort A1 (SAD Dose 1) | Experimental | Biological: Human beta common receptor antagonist monoclonal antibodyHuman beta common receptor antagonist monoclonal antibody administered intravenously at a Single Ascending Dose (SAD) |
| CSL311 Cohort A2 (SAD Dose 2) | Experimental | Biological: Human beta common receptor antagonist monoclonal antibodyHuman beta common receptor antagonist monoclonal antibody administered intravenously at a SAD |
| CSL311 Cohort A3 (SAD Dose 3) | Experimental | Biological: Human beta common receptor antagonist monoclonal antibodyHuman beta common receptor antagonist monoclonal antibody administered intravenously at a SAD |
| CSL311 Cohort A4 (SAD Dose 4) | Experimental | Biological: Human beta common receptor antagonist monoclonal antibodyHuman beta common receptor antagonist monoclonal antibody administered intravenously at a SAD |
| CSL311 Cohort A5 (SAD Dose 5) | Experimental | Biological: Human beta common receptor antagonist monoclonal antibodyHuman beta common receptor antagonist monoclonal antibody administered intravenously at a SAD |
| CSL311 Cohort A6 (SAD Dose 6) | Experimental | Biological: Human beta common receptor antagonist monoclonal antibodyHuman beta common receptor antagonist monoclonal antibody administered intravenously at a SAD |
| CSL311 Cohort A7 (SAD Dose 7) | Experimental | Biological: Human beta common receptor antagonist monoclonal antibodyHuman beta common receptor antagonist monoclonal antibody administered intravenously at a SAD |
| CSL311 Cohort A8 (SAD Dose 8) | Experimental | Biological: Human beta common receptor antagonist monoclonal antibodyHuman beta common receptor antagonist monoclonal antibody administered intravenously at a SAD |
| CSL311 Cohort B1 (MAD Dose 1) | Experimental | Biological: Human beta common receptor antagonist monoclonal antibodyHuman beta common receptor antagonist monoclonal antibody administered intravenously at a MAD |
| Placebo | Placebo comparator | Drug: Placebo0.9% sodium chloride solution administered intravenously |
| Placebo (2) | Placebo comparator | Drug: Placebo0.9% sodium chloride solution administered subcutaneously |
| CSL311 Cohort C1 (MAD Dose 1) | Experimental | Biological: Human beta common receptor antagonist monoclonal antibodyHuman beta common receptor antagonist monoclonal antibody administered subcutaneously (SC) |
| CSL311 Cohort C2 (MAD Dose 2) | Experimental | Biological: Human beta common receptor antagonist monoclonal antibodyHuman beta common receptor antagonist monoclonal antibody administered subcutaneously |
| CSL311 Cohort C3 (MAD Dose 3) | Experimental | Biological: Human beta common receptor antagonist monoclonal antibodyHuman beta common receptor antagonist monoclonal antibody administered subcutaneously |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human beta common receptor antagonist monoclonal antibodyAlso: CSL311Human beta common receptor antagonist monoclonal antibody | Biological | CSL311 Cohort A1 (SAD Dose 1), CSL311 Cohort A2 (SAD Dose 2), CSL311 Cohort A3 (SAD Dose 3), CSL311 Cohort A4 (SAD Dose 4), CSL311 Cohort A5 (SAD Dose 5), CSL311 Cohort A6 (SAD Dose 6), CSL311 Cohort A7 (SAD Dose 7), CSL311 Cohort A8 (SAD Dose 8), CSL311 Cohort B1 (MAD Dose 1), CSL311 Cohort C1 (MAD Dose 1), CSL311 Cohort C2 (MAD Dose 2), CSL311 Cohort C3 (MAD Dose 3) |
| Placebo0.9% sodium chloride, same volume and same duration as CSL311 | Drug | Placebo, Placebo (2) |
Primary outcome
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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Severity of TEAEs defined as mild, moderate, or severe
28 secondary outcomes
Maximum plasma concentration (Cmax) of CSL311 in SAD
Time frame: Up to 85 days after infusion
Time to reach Cmax (tmax) of CSL311 in SAD
Time frame: 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
Time frame: 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
Time frame: Up to 85 days after infusion
Half-life (t½) of CSL311 in SAD
Time frame: Up to 85 days after infusion
Clearance (CL) of CSL311 in SAD
Time frame: Up to 85 days after infusion
Volume of distribution (Vd) of CSL311 in SAD
Time frame: 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
Time frame: Up to 85 days after infusion
Cmax/dose of CSL311 in SAD
Time frame: Up to 85 days after infusion
AUCtau for CSL311 in MAD (SC and IV) after first dose
Time frame: Up to 15 days after infusion or injection
AUCtau/dose for CSL311 in MAD (SC and IV) after first dose
Time frame: Up to 15 days after infusion or injection
Cmax of CSL311 in MAD (SC and IV) after first dose
Time frame: Up to 15 days after infusion or injection
Cmax/dose of CSL311 in MAD (SC and IV) after first dose
Time frame: Up to 15 days after infusion or injection
tmax of CSL311 in MAD (SC and IV) after first dose
Time frame: Up to 15 days after infusion or injection
Cmax of CSL311 in MAD (SC and IV) after last dose
Time frame: Up to 85 days (SC) and 114 days (IV) after infusion or injection
AUCtau for CSL311 in MAD (SC and IV) after last dose
Time frame: 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
Time frame: Up to 85 days (SC) and 114 days (IV) after infusion or injection
tmax of CSL311 in MAD (SC and IV) after last dose
Time frame: 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
Time frame: 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
Time frame: Up to 85 days (SC) and 114 days (IV) after infusion or injection
Clearance (CL) of CSL311 in MAD (IV) after last dose
Time frame: Up to 114 days after infusion
Apparent Clearance (CL/F) of CSL311 in MAD (SC) after last dose
Time frame: Up to 85 days after injection
Volume of distribution (Vd) of CSL311 in MAD (IV) after last dose
Time frame: Up to 114 days after infusion
Apparent volume of distribution during terminal phase (Vz/F) of CSL311 in MAD (SC) after last dose
Time frame: Up to 85 days after injection
Number of subjects with detectable anti-CSL311 antibodies in SAD and MAD (SC and IV)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: After infusion or injection, up to 85 days for SAD, and up to 85 days for MAD (SC) and 114 days for MAD (IV)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
CSL Behring
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Human beta common receptor antagonist monoclonal antibody in people with Asthma, run by CSL Behring at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.