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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
48
TB006
Sterile saline
Collaborative Neuroscience Research, LLC (CNS)
Long Beach, California, United States
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.
Time frame: 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
Time frame: 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
Time frame: Through day 75
Pharmacokinetic (PK) profile/parameters: Area under the plasma concentration versus time curve (AUC) through Day 29
PK:AUC D0-D29
Time frame: Through Day 75
Pharmacokinetic (PK) profile/parameters: Area under the plasma concentration versus time curve (AUC)
PK: AUC D0-∞
Time frame: Through Day 75
Pharmacokinetic (PK) profile/parameters: Maximum observed plasma concentration
PK: Cmax
Time frame: Through Day 75
Pharmacokinetic (PK) profile/parameters: Time at which maximum plasma concentration occurs
PK: tmax
Time frame: Through Day 75
Pharmacokinetic (PK) profile/parameters: terminal elimination phase half life
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PK: t(1/2)
Time frame: Through Day 75
Pharmacokinetic (PK) profile/parameters: total clearance
PK: CL
Time frame: Through Day 75
Pharmacokinetic (PK) profile/parameters: volume of distribution
PK: Vd
Time frame: Through Day 75
Pharmacokinetic (PK) profile/parameters: Extent of CSF distribution as estimated by TB006 CSF concentrations
PK: CSF
Time frame: 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
Time frame: Through Day 75
Anti-TB006 antibodies
Number and rate of subjects who develop anti-TB006 antibodies
Time frame: Through Day 75