NCT05074498

Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of TB006 in Participants With Alzheimer's Disease

A Seamless Phase 1b/2a Double-blind, Randomized, Multiple Dose, Multi-center, Sequential Dose-escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of TB006 in Patients With Mild to Severe Alzheimer's Disease

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: TrueBinding, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

Part 1 of this study will be conducted to determine the safety, tolerability, and pharmacokinetic (PK) profile of multiple doses of TB006, as well as the maximum tolerated dose of TB006, and to assess the immunogenicity of TB006 (production of anti-TB006 antibody). Part 2 of this study will be conducted to determine the clinical efficacy of TB006 in participants with mild to severe Alzheimer's Disease.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	TB006	intravenous infusion
DRUG	Placebo	intravenous infusion

Timeline

• Start date: 2021-10-08
• Primary completion: 2022-10-13
• Completion: 2022-10-13
• First posted: 2021-10-12
• Last updated: 2023-11-18
• Results posted: 2023-11-18

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study