NCT05827653

MAD Study of NX210c

A Double-blind, Randomized, Placebo-controlled, Multiple Ascending Dose (MAD) Study in Healthy Elderly Volunteers and Alzheimer's Disease (AD) Patients to Investigate the Safety and Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) Effects of Multiple Intravenous Infusions of NX210c

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Axoltis Pharma · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Accepted

Summary

This study will investigate the safety and tolerability of multiple intravenous infusions of NX210c with two ascending doses as well as NX210c pharmacokinetics (PK), and pharmacodynamics (PD) effects in healthy elderly subjects.

Detailed description

The prevalence of neurocognitive disorders (NCD), including neurodegenerative diseases (NDDs) such as Alzheimer's disease (AD) is increasing. NDDs are most common and prevalent in elderly people worldwide and cause progressive neuronal dysfunction, toxicities, and death. These diseases lead to an irreversible weakening of all brain functions, including cognitive impairment. There is not one single cause of cognitive impairment but rather several factors that can contribute to trigger or accelerate cognitive decline. Preclinical in vitro and in vivo data have shown that NX210c exhibits important properties, which may be suitable for the treatment of neurological disorders in humans. (i.e., neuroprotection, neuro-regeneration, synaptic transmission, positive effects on cognition, anti-neuroinflammatory action). The First In Human Single Ascending Dose study has been completed. In that study, NX210 was administered and well tolerated. The current project is a multiple ascending dose (MAD) study and designed to investigate the safety, tolerability, PK and pharmacodynamics (PD) effects of multiple intravenous infusions of NX210c in two dose levels in healthy elderly subjects.

Conditions

• Healthy Elderly

Interventions

Type	Name	Description
DRUG	NX210c	3 times a week, for 28 days
DRUG	Placebo	3 times a week, for 28 days

Timeline

• Start date: 2022-12-05
• Primary completion: 2023-04-29
• Completion: 2023-10-02
• First posted: 2023-04-25
• Last updated: 2024-12-13

Locations

1 site across 1 country: Netherlands