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This is a single dose, dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of TB006, a monoclonal antibody that will be studied as a disease modifying treatment for Alzheimer's disease.
The TB006 nonclinical pharmacology program establishes its potential as a therapeutic agent for AD. Overall, the data suggest the potential for beneficial therapeutic effects of TB006 in addressing underlying pathology and ameliorating the course of AD. The preclinical safety profile of TB006 further supports the clinical investigation of TB006. This is a Phase 1 SAD study in healthy adult subjects. The study will evaluate the safety, tolerability, and PK of single doses of TB006, administered as an IV infusion over 1 hour.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TB006 70 mg - 5000 mg IV | Experimental | TB006 infused intravenously over 1 hour |
|
| Placebo | Placebo Comparator | 0.9% normal saline infused intravenously over 1 hour |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TB006 | Drug | TB006 |
| |
| Sterile saline (Placebo) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects and rate of treatment-emergent adverse events, graded by CTCAE Version 5.0, by dose group and all active treatment vs. placebo | To measure the incidence of AEs and SAEs, clinical laboratory parameters, and vital signs until Day 75 after dosing. | Day1-Day 75 |
| To determine the single-dose PK profile of TB006 in healthy adult subjects | PK parameters derived by noncompartmental analysis using the TB006 plasma concentration-time data | Through day 75 |
| To determine the MTD of single doses of TB006 in healthy adult subjects | Dose-response relationship of AEs and SAEs, and other safety outcomes | Through day 75 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) profile/parameters: Area under the plasma concentration versus time curve (AUC) through Day 29 | PK:AUC D0-D29 | Through Day 75 |
| Pharmacokinetic (PK) profile/parameters: Area under the plasma concentration versus time curve (AUC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George Haig, PharmD | TrueBinding, Inc. | Study Director |
| David Walling, MD | Collaborative Neuroscience Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Collaborative Neuroscience Research, LLC (CNS) | Long Beach | California | 90806 | 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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| ID | Term |
|---|---|
| C000715407 | TB006 |
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Six dose groups are planned: 5 dose levels of TB006 in healthy subjects and 1 ethno-bridging group in healthy subjects of Chinese descent.
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| Other |
Sterile saline |
|
PK: AUC D0-∞
| Through Day 75 |
| Pharmacokinetic (PK) profile/parameters: Maximum observed plasma concentration | PK: Cmax | Through Day 75 |
| Pharmacokinetic (PK) profile/parameters: Time at which maximum plasma concentration occurs | PK: tmax | Through Day 75 |
| Pharmacokinetic (PK) profile/parameters: terminal elimination phase half life | PK: t(1/2) | Through Day 75 |
| Pharmacokinetic (PK) profile/parameters: total clearance | PK: CL | Through Day 75 |
| Pharmacokinetic (PK) profile/parameters: volume of distribution | PK: Vd | Through Day 75 |
| Pharmacokinetic (PK) profile/parameters: Extent of CSF distribution as estimated by TB006 CSF concentrations | PK: CSF | Through Day 75 |
| Safety and tolerability | Number of subjects and rate of treatment-emergent adverse events, graded by CTCAE Version 5.0, by dose group and all active treatment vs. placebo in non-Chinese healthy and Chinese healthy subjects | Through Day 75 |
| Anti-TB006 antibodies | Number and rate of subjects who develop anti-TB006 antibodies | Through Day 75 |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |