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The purpose of this study is to determine the safety, tolerability and pharmacokinetics of ALD403, a monoclonal antibody, administered by intravenous infusion and subcutaneous injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A, Cohorts A - H | Experimental | ALD403/Placebo |
|
| Part A, Cohort I | Experimental | ALD403/Placebo |
|
| Part B | Experimental | ALD403/Placebo/Sumatriptan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALD403 | Biological | Single Dose IV infusion on Day 1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of ALD403: laboratory variables, ECG and adverse events |
| 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Pharmacokinetics of ALD403 |
| 12 weeks |
| Evaluation of pharmacodynamics of ALD403 |
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Inclusion Criteria Part A:
Exclusion Criteria Part A:
Inclusion Criteria Part B:
Exclusion Criteria Part B:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Hodsman, MD | Nucleus Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Clinical Studies, Nucleus Network | Melbourne | Victoria | 3004 | 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 |
|---|---|
| C000628361 | eptinezumab |
| D018170 | Sumatriptan |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| ALD403 |
| Biological |
Single Dose subcutaneous injection on Day 1 |
|
| Sumatriptan | Biological | Single Dose subcutaneous injection on Day 1 |
|
|
| 12 weeks |
| D009422 | Nervous System Diseases |
| Sulfur Compounds |
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |