NCT05551741

A First in Human Study of IBC-Ab002 in Persons With Early Alzheimer's Disease (AD)

A First in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of IBC-Ab002 in Persons With Early Alzheimer's Disease (AD)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Immunobrain Checkpoint · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled first-in-human, Phase 1, safety, tolerability, pharmacokinetic (PK) and preliminary exploratory activity study of escalating multiple intravenous (IV) doses of IBC-Ab002 in persons with early Alzheimer's disease. The study will have both Single- and Multiple-Ascending Dose components.

Detailed description

Subjects in 5 sequential cohorts of 8 subjects each will be assigned in a 3:1 ratio to receive either IBC-Ab002 or matching placebo 4 times. Part A will be a single-ascending dose study and Part B will be a multiple ascending dose study. The two parts of the study will be intercalated such that subjects will be dosed once every 12 weeks. However, repeated dosing at any dose level will not begin until the anticipated cumulative dose for that cohort has been equaled or exceeded in Part A and/or B of the study, and appropriate safety review of data from all preceding doses in prior subjects has taken place. All subjects randomized into Part A of the study will automatically continue into Part B unless dosing is halted at the individual or group level due to safety or other concerns.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
BIOLOGICAL	IBC-Ab002	An anti-PD-L1 monoclonal antibody
OTHER	Placebo	Normal Saline

Timeline

• Start date: 2023-02-23
• Primary completion: 2025-12-16
• Completion: 2025-12-16
• First posted: 2022-09-23
• Last updated: 2025-12-24

Locations

10 sites across 3 countries: Israel, Netherlands, United Kingdom