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This is a Phase 1, first in human (FIH), double-blind, placebo-controlled, single ascending dose (SAD) trial to assess the safety, tolerability, and pharmacokinetics (PK) of intravenously (IV) or subcutaneously (SC) injected ALIA-1758 in healthy male and female participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | Single Ascending Dose (SAD) cohorts |
|
| Placebo | Placebo Comparator | Single Ascending Dose (SAD) cohorts |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALIA-1758 | Drug | Intravenous or subcutaneous doses |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Incidence, severity, seriousness, and causality of treatment-emergent adverse events (TEAEs) | Up to 85 days after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Cmax | Cmax | 0-85 days after dosing |
| Pharmacokinetic parameters of ALIA-1758 in healthy subjects: T1/2 | elimination half-life (T1/2) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Other criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| J. Michael Ryan, M.D. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Worldwide Clinical Trials Early Phase Services, LLC | San Antonio | Texas | 78217 | United States |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Other |
Intravenous or subcutaneous doses |
|
| 0-85 days after dosing |
| Pharmacokinetic parameters of ALIA-1758 in healthy subjects: AUC | Area Under Curve (AUC) | 0-85 days after dosing |
| Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Bioavailability | Bioavailability after SC administration (F) | 0-85 days after dosing |
| Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Clearance | Clearance (CL) | 0-85 days after dosing |
| Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Volume of distribution | Volume of distribution (Vz) | 0-85 days after dosing |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |