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Sponsor decision to terminate program
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| Name | Class |
|---|---|
| Syneos Health | OTHER |
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This trial will study the effects of single and multiple doses of ALXN1830 in healthy adult participants.
This is a Phase 1 study in healthy adult participants. The study will consist of 2 single ascending dose (Cohorts 1 and 2) and 4 multiple ascending dose cohorts (Cohorts 3 to 6). Participants will be randomly assigned to each of the 6 cohorts to receive either single or multiple doses of ALXN1830 subcutaneous (SC) or single or multiple doses of placebo SC. Cohort 6 will enroll only healthy participants of Japanese descent who will be dosed according to the highest tolerated dose (HTD) established in the non-Japanese cohorts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: ALXN1830 Single Dose 1/Placebo | Experimental | Participants will receive a single SC dose of ALXN1830 or placebo. |
|
| Cohort 2: ALXN1830 Single Dose 2/Placebo | Experimental | Participants will receive a single SC dose of ALXN1830 or placebo. |
|
| Cohort 3: ALXN1830 Multiple Dose 1/Placebo | Experimental | Participants will receive multiple SC doses of ALXN1830 or placebo. |
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| Cohort 4: ALXN1830 Multiple Dose 2/Placebo | Experimental | Participants will receive multiple SC doses of ALXN1830 or placebo. |
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| Cohort 5: ALXN1830 Multiple Dose 3/Placebo | Experimental | Participants will receive multiple SC doses of ALXN1830 or placebo. |
|
| Cohort 6: ALXN1830 /Placebo in Japanese Population |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALXN1830 | Drug | ALXN1830 will be administered as SC infusion(s). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An AE was any untoward medical occurrence in a participant administered the study drug and which did not necessarily have a causal relationship with this treatment. A TEAE was defined as an AE with a start date or time on or after the first dose of the study intervention. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section. | Day 1 (postdose) through follow-up (up to approximately 141 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Single-Dose Cohorts: Area Under the Serum Concentration-time Curve From Time 0 (Dosing) To Time Infinity (AUC0-inf) of ALXN1830 | Serum total drug concentrations were measured using a validated liquid chromatography/mass spectrometry (LC/MS) assay. | Day 1 (predose) up to Day 64 (postdose) |
| Multiple-Dose Cohorts: AUC0-inf of ALXN1830 at Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Auckland | New Zealand | ||||
| Research Site |
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 34 participants (25 ALXN1830 treated and 9 placebo-treated) were enrolled and randomized in a 6:2 ratio in 5 cohorts. Healthy, Japanese participants were planned to be dosed in Cohort 6 according to the highest tolerated dose (HTD) established in the non-Japanese cohorts. This cohort was not achieved due to early termination of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: ALXN1830 Single Medium Dose | Participants received a single subcutaneous (SC) medium dose of ALXN1830. |
| FG001 | Cohort 2: ALXN1830 Single Hign Dose | Participants received a single SC high dose of ALXN1830. |
| FG002 | Cohort 3: ALXN1830 Multiple Low Dose | Participants received multiple SC low doses of ALXN1830 once weekly (QW). |
| FG003 | Cohort 4: ALXN1830 Multiple Medium Dose | Participants received multiple SC medium doses of ALXN1830 QW. |
| FG004 | Cohort 5: ALXN1830 Multiple High Dose | Participants received multiple SC high doses of ALXN1830 QW. |
| FG005 | Placebo | Participants received placebo matched to ALXN1830. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Safety Set included all participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: ALXN1830 Single Medium Dose | Participants received a single SC medium dose of ALXN1830. |
| BG001 | Cohort 2: ALXN1830 Single High Dose | Participants received a single SC high dose of ALXN1830. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An AE was any untoward medical occurrence in a participant administered the study drug and which did not necessarily have a causal relationship with this treatment. A TEAE was defined as an AE with a start date or time on or after the first dose of the study intervention. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section. | The Safety Set included all participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Day 1 (postdose) through follow-up (up to approximately 141 days) |
|
Day 1 (postdose) through follow-up (up to approximately 141 days)
The Safety Set included 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 | Cohort 1: ALXN1830 Single Medium Dose | Participants received a single SC medium dose of ALXN1830. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexion Pharmaceuticals, Inc. | Alexion Pharmaceuticals, Inc. | 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 | Jun 25, 2021 | Aug 9, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 24, 2022 | Aug 9, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Experimental |
Japanese participants will receive multiple SC doses of ALXN1830 (HTD) or placebo. |
|
| Placebo | Drug | Placebo will be administered as SC infusion(s). |
|
|
Serum total drug concentrations were measured using a validated LC/MS assay. |
| Day 1 (predose up to 12 hours postdose) |
| Multiple-Dose Cohorts: AUC0-inf of ALXN1830 at Day 22 | Serum total drug concentrations were measured using a validated LC/MS assay. | Day 22 (predose up to 12 hours postdose) |
| Multiple-Dose Cohorts: AUC0-inf of ALXN1830 at Day 78 | Serum total drug concentrations were measured using a validated LC/MS assay. | Day 78 (predose up to 12 hours postdose) |
| Change From Baseline in Serum Immunoglobulin G (IgG) at Early Termination Visit (up to Day 141) | Serum concentration of IgG was measured using validated nephelometric assays. | Baseline, early termination visit (up to Day 141) |
| Percent FcRN Receptor Occupancy at Day 120 | Day 120 |
| Number of Participants With Antidrug Antibodies (ADA) and Neutralizing Antibodies (NAb) to ALXN1830 | Day 1 (postdose) through follow-up (up to approximately 141 days) |
| Grafton |
| 1010 |
| New Zealand |
| Withdrawal by Subject |
|
| BG002 | Cohort 3: ALXN1830 Multiple Low Dose | Participants received multiple SC low doses of ALXN1830 QW. |
| BG003 | Cohort 4: ALXN1830 Multiple Medium Dose | Participants received multiple SC medium doses of ALXN1830 QW. |
| BG004 | Cohort 5: ALXN1830 Multiple High Dose | Participants received multiple SC high doses of ALXN1830 QW. |
| BG005 | Placebo | Participants received placebo matched to ALXN1830. |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 |
| Cohort 2: ALXN1830 Single High Dose |
Participants received a single SC high dose of ALXN1830. |
| OG002 | Cohort 3: ALXN1830 Multiple Low Dose | Participants received multiple SC low doses of ALXN1830 QW. |
| OG003 | Cohort 4: ALXN1830 Multiple Medium Dose | Participants received multiple SC medium doses of ALXN1830 QW. |
| OG004 | Cohort 5: ALXN1830 Multiple High Dose | Participants received multiple SC high doses of ALXN1830 QW. |
| OG005 | Placebo | Participants received placebo matched to ALXN1830. |
|
|
| Secondary | Single-Dose Cohorts: Area Under the Serum Concentration-time Curve From Time 0 (Dosing) To Time Infinity (AUC0-inf) of ALXN1830 | Serum total drug concentrations were measured using a validated liquid chromatography/mass spectrometry (LC/MS) assay. | The Pharmacokinetic Set included all participants who received at least 1 dose of study drug (only active) and had at least 1 postdose serum ALXN1830 concentration measured. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | hours*milligram (mg)/liter (L) | Day 1 (predose) up to Day 64 (postdose) |
|
|
|
| Secondary | Multiple-Dose Cohorts: AUC0-inf of ALXN1830 at Day 1 | Serum total drug concentrations were measured using a validated LC/MS assay. | The Pharmacokinetic Set included all participants who received at least 1 dose of study drug (only active) and had at least 1 postdose serum ALXN1830 concentration measured. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. Per prespecified analysis, only participants in Cohort 5 were analyzed for this outcome measure. | Posted | Mean | Standard Deviation | hours*mg/L | Day 1 (predose up to 12 hours postdose) |
|
|
|
| Secondary | Multiple-Dose Cohorts: AUC0-inf of ALXN1830 at Day 22 | Serum total drug concentrations were measured using a validated LC/MS assay. | The Pharmacokinetic Set included all participants who received at least 1 dose of study drug (only active) and had at least 1 postdose serum ALXN1830 concentration measured. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. Per prespecified analysis, only participants in Cohort 4 were analyzed for this outcome measure. | Posted | Mean | Standard Deviation | hours*mg/L | Day 22 (predose up to 12 hours postdose) |
|
|
|
| Secondary | Multiple-Dose Cohorts: AUC0-inf of ALXN1830 at Day 78 | Serum total drug concentrations were measured using a validated LC/MS assay. | The Pharmacokinetic Set included all participants who received at least 1 dose of study drug (only active) and had at least 1 postdose serum ALXN1830 concentration measured. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. Per prespecified analysis, only participants in Cohort 3 were analyzed for this outcome measure. | Posted | Mean | Standard Deviation | hours*mg/L | Day 78 (predose up to 12 hours postdose) |
|
|
|
| Secondary | Change From Baseline in Serum Immunoglobulin G (IgG) at Early Termination Visit (up to Day 141) | Serum concentration of IgG was measured using validated nephelometric assays. | The Pharmacodynamic Set included all participants who received at least 1 dose of study drug (active and placebo) who had evaluable serum Immunoglobulin data (IgG, IgG subtypes, Ig subtypes, and circulating immune complexes [CIC]) or neonatal crystallizable fragment receptor (FcRn) data. | Posted | Mean | Standard Deviation | grams (g)/L | Baseline, early termination visit (up to Day 141) |
|
|
|
| Secondary | Percent FcRN Receptor Occupancy at Day 120 | The Pharmacodynamic Set included all participants who received at least 1 dose of study drug (active and placebo) who had evaluable serum Immunoglobulin data (IgG, IgG subtypes, Ig subtypes, and CIC) or FcRn data. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | percentage of receptor occupied | Day 120 |
|
|
|
| Secondary | Number of Participants With Antidrug Antibodies (ADA) and Neutralizing Antibodies (NAb) to ALXN1830 | The Immunogenicity Set included all participants who had a predose (baseline) and at least 1 postdose ADA sample collected. | Posted | Count of Participants | Participants | Day 1 (postdose) through follow-up (up to approximately 141 days) |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 6 |
| 6 |
| EG001 | Cohort 2: ALXN1830 Single High Dose | Participants received a single SC high dose of ALXN1830. | 0 | 1 | 0 | 1 | 1 | 1 |
| EG002 | Cohort 3: ALXN1830 Multiple Low Dose | Participants received multiple SC low doses of ALXN1830 QW. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG003 | Cohort 4: ALXN1830 Multiple Medium Dose | Participants received multiple SC medium doses of ALXN1830 QW. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG004 | Cohort 5: ALXN1830 Multiple High Dose | Participants received multiple SC high doses of ALXN1830 QW. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG005 | Placebo | Participants received placebo matched to ALXN1830. | 0 | 9 | 0 | 9 | 7 | 9 |
| Injection site pain | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Injection site bruising | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Injection site induration | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Catheter site pain | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Catheter site vesicles | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Feeling abnormal | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Injection site discomfort | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Injection site inflammation | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Injection site paraesthesia | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Injection site urticaria | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Mass | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Medical device site reaction | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Vessel puncture site bruise | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Tension headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Acarodermatitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Gonorrhoea | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Vulvovaginal candidiasis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Frequent bowel movements | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Salivary gland pain | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| Limb injury | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| Skin laceration | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Phlebitis | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
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| Flushing | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
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| Eye pain | Eye disorders | MedDRA 23.1 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA 23.1 | Systematic Assessment |
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| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 23.1 | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
|
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| NAb |
|