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| ID | Type | Description | Link |
|---|---|---|---|
| 18902A | Other Identifier | H. Lundbeck A/S |
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| Name | Class |
|---|---|
| Alder Biopharmaceuticals, Inc. | INDUSTRY |
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The purpose of this study is to determine the safety, tolerability and pharmacokinetics of ALD1910, a monoclonal antibody, administered by intravenous infusion and subcutaneous injection.
This is a first-in-humam, randomized, double-blind, placebo-controlled study in a healthy population. Up to 7 single ascending doses (cohorts 1 to 7) will be studied to determine the safety and tolerability of ALD1910. Approximately 96 healthy male and female participants are planned for the study, 64 for Part A and 32 for Part B.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A Cohort 1-8 | Experimental | ALD1910/Placebo; Single Dose IV infusion on Day 1 |
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| Part B Cohort 9 | Experimental | ALD1910/Placebo+Sumatriptan; Single Dose IV infusion on Day 1 |
|
| Part B Cohort 10 | Experimental | ALD1910/Placebo; Single dose subcutaneous injection on Day 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALD1910 | Biological | Single Dose IV infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-emergent adverse events | Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, ECG parameters) | From dosing to week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum concentration-time curve (AUC(0-T)) | From dosing to week 20 | |
| Peak serum concentration (Cmax) | From dosing to week 20 | |
| Clearance (Cl) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network Pty Ltd | Melbourne | Australia |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D018170 | Sumatriptan |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| Sumatriptan |
| Biological |
Single dose subcutaneous injection |
|
| ALD1910 | Biological | Single dose subcutaneous injection |
|
| From dosing to week 20 |
| Immunogenicity | Number of anti-ALD1910 antibodies (ADA) and characterization of anti-ALD1910 ADA positive responses for neutralizing activity | From dosing to week 20 |
| D009422 | Nervous System Diseases |
| Sulfur Compounds |
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |