NCT03375697

A Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-63733657 in Healthy Subjects and Subjects With Alzheimer's Disease

A 2-Part Randomized, Placebo-Controlled, Double-Blind, Single and Multiple Ascending Dose Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-63733657 in Healthy Subjects and Subjects With Alzheimer's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 55 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety and tolerability of JNJ-63733657 following single ascending intravenous (IV) dose administration in healthy subjects (Part 1) and multiple ascending IV dose administrations in subjects with prodromal or mild Alzheimer's disease (AD) (Part 2).

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	JNJ-63733657	Subjects will receive single (Part 1) or multiple (Part 2) ascending dose levels of JNJ-63733657 intravenously.
DRUG	Placebo	Subjects will receive matching placebo intravenously.

Timeline

• Start date: 2017-12-22
• Primary completion: 2019-12-16
• Completion: 2019-12-16
• First posted: 2017-12-18
• Last updated: 2025-04-27

Locations

7 sites across 4 countries: Belgium, Germany, Netherlands, Spain