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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-003496-18 | EudraCT Number |
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The justification of the early termination of the trial: the study is early terminated due to the Coronavirus 2019 epidemic.
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This study will evaluate the effects of single ascending doses (SAD) and multiple ascending doses (MAD) of ALXN1830 administered subcutaneously (SC) to healthy adult participants.
This Phase 1 study will consist of 3 SAD (Cohorts 1 to 3) and 4 MAD (Cohorts 4 to 7) cohorts. Participants will be randomly assigned in a 6:2 ratio to each of the 7 cohorts to receive either single or multiple doses of ALXN1830 (n = 6 per cohort) or single or multiple doses of placebo (n = 2 per cohort).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Participants will receive a single SC dose of ALXN1830 or placebo (750 mg). |
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| Cohort 2 | Experimental | Participants will receive a single SC dose of ALXN1830 or placebo (1500 mg). |
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| Cohort 3 | Experimental | Participants will receive a single SC dose of ALXN1830 or placebo (2250 mg). |
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| Cohort 4 | Experimental | Participants will receive multiple SC doses of ALXN1830 or placebo (300 mg twice weekly; 8 doses total). |
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| Cohort 5 | Experimental | Participants will receive multiple SC doses of ALXN1830 or placebo (750 mg once weekly; 12 doses total). |
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| Cohort 6 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALXN1830 | Drug | ALXN1830 will be administered as SC infusion(s). |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | A TEAE was defined as any adverse event (AE) that commences after the start of administration of study drug. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. An AE was considered serious if, in the view of the investigator or sponsor, it resulted in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. A summary of all serious AEs and other AEs (nonserious) regardless of causality is located in 'Adverse events' Section. | Baseline up to Day 64 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under The Serum Concentration Versus Time Curve From Time Zero (Dosing) To The Last Quantifiable Concentration (AUC0-t) of ALXN1830 | Predose, end of infusion, and 0.5, 2, 4, 8, and 12 hours postdose on Day 1; and Days 2 to 8 | |
| Percent Change From Baseline in Immunoglobulin G (IgG) Levels at Day 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | London | United Kingdom |
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| Label | URL |
|---|---|
| CSR Synopsis | View source |
| Related Info | View source |
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Due to a lack of participant availability caused by the COVID-19 pandemic, the study was terminated on 22 January 2021 after completion of the ALXN1830 subcutaneous 750 milligrams (mg) dose or placebo groups and partial enrollment of the ALXN1830 subcutaneous 1250 mg dose or placebo groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | ALXN1830 750 mg | Participants received a single dose of ALXN1830 750 mg subcutaneously on Day 1. |
| FG001 | ALXN1830 1250 mg | Participants received a single dose of ALXN1830 1250 mg subcutaneously on Day 1. |
| FG002 | Placebo | Participants received placebo matched to ALXN1830 subcutaneously on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The safety population consisted of all participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | ALXN1830 750 mg | Participants received a single dose of ALXN1830 750 mg subcutaneously on Day 1. |
| BG001 | ALXN1830 1250 mg | Participants received a single dose of ALXN1830 1250 mg subcutaneously on Day 1. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Area Under The Serum Concentration Versus Time Curve From Time Zero (Dosing) To The Last Quantifiable Concentration (AUC0-t) of ALXN1830 | The pharmacokinetic (PK) population consisted of all participants who had sufficient serum ALXN1830 concentration data to evaluate PK parameters. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | hour*nanogram/milliliter | Predose, end of infusion, and 0.5, 2, 4, 8, and 12 hours postdose on Day 1; and Days 2 to 8 |
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Baseline up to Day 64
The safety population consisted of all participants who received at least 1 dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ALXN1830 750 mg | Participants received a single dose of ALXN1830 750 mg subcutaneously on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
The study was terminated early due to a lack of participant availability caused by COVID-19 pandemic after completion of the ALXN1830 750 mg dose group and partial enrollment of the ALXN1830 1250 mg dose group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexion Pharmaceuticals Inc. | Alexion Pharmaceuticals Inc. | +1 855-752-2356 | clinicaltrials@alexion.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 24, 2020 | Jul 24, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 24, 2021 | Jul 24, 2023 | SAP_001.pdf |
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Participants will receive multiple SC doses of ALXN1830 or placebo (1500 mg once weekly; 4 doses total). |
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| Cohort 7 | Experimental | Participants will receive multiple SC doses of ALXN1830 or placebo (2250 mg once weekly; 4 doses total). |
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| Placebo | Drug | Placebo will be administered as SC infusion(s). |
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| Baseline, Day 10 |
| Number of Participants With Positive Anti-Drug Antibodies (ADA) | Baseline up to Day 64 |
| Number of Participants With Positive Neutralizing Antibodies (NAbs) | All samples that are confirmed positive for ADA were evaluated for the presence of neutralizing antibodies. | Baseline up to Day 64 |
| Related Info | View source |
| Related Info | View source |
| BG002 | Placebo | Participants received placebo matched to ALXN1830 subcutaneously on Day 1. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Secondary | Percent Change From Baseline in Immunoglobulin G (IgG) Levels at Day 10 | The pharmacodynamic (PD) population consisted of all participants who had sufficient serum IgG data to evaluate pharmacodynamics effects. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 10 |
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| Secondary | Number of Participants With Positive Anti-Drug Antibodies (ADA) | The immunogenicity population consisted of all participants who had ADA sample collected. | Posted | Count of Participants | Participants | Baseline up to Day 64 |
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| Secondary | Number of Participants With Positive Neutralizing Antibodies (NAbs) | All samples that are confirmed positive for ADA were evaluated for the presence of neutralizing antibodies. | The immunogenicity population consisted of all participants who had ADA sample collected. Here, 'Overall number of participants analyzed' = participants with positive ADA. | Posted | Count of Participants | Participants | Baseline up to Day 64 |
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| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | A TEAE was defined as any adverse event (AE) that commences after the start of administration of study drug. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. An AE was considered serious if, in the view of the investigator or sponsor, it resulted in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. A summary of all serious AEs and other AEs (nonserious) regardless of causality is located in 'Adverse events' Section. | The safety population consisted of all participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Baseline up to Day 64 |
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| 0 |
| 6 |
| 0 |
| 6 |
| 5 |
| 6 |
| EG001 | ALXN1830 1250 mg | Participants received a single dose of ALXN1830 1250 mg subcutaneously on Day 1. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG002 | Placebo | Participants received placebo matched to ALXN1830 subcutaneously on Day 1. | 0 | 3 | 0 | 3 | 3 | 3 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Food poisoning | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Injection site discomfort | General disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA 23.0 | Non-systematic Assessment |
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