MAD Study of NX210c

Healthy Elderly Clinical Trial

— CHDR2235  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05827653
• Other study ID #: AXO-CLI-210c-02
• Secondary ID: 2022-002868-76
• Status: Recruiting
• Phase: Phase 1
• Start date: December 5, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: January 2024
• Source: Axoltis Pharma
• Contact: Daniel Dumas, MD
• Phone: +31 71 5246 400
• Email: clintrials[@]chdr.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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, firstly in healthy elderly subjects, and the recommended dose to be used for Alzheimer's disease patients, in a second step.

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. An additional cohort enrolling patient with Alzheimer disease (AD) to further evaluate NX210c is planned for this study but design is still in development.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• Healthy adult male or female participants, as determined by the Investigator, based upon a medical evaluation including medical history, physical examination, neurological examination, MMSE, MRI, lab tests and ECG.
• Aged = 55 years, inclusive at screening, and with a maximum weight of 110 kg.
• Body mass index (BMI) between 18 and 32 kg/m2, inclusive at screening.

Exclusion Criteria:

• Evidence of any history, or any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator
• History of any known neurologic disease, cognitive impairment, or diagnosed decline in cognitive function abnormal related to the age, or history of seizure, (significant) head trauma, loss of consciousness, or significant neuroimaging findings, including but not limited to any previously known or discovered abnormalities on screening brain MRI that evoke neurological diagnosis indicative of clinically significant abnormality

Related Conditions & MeSH terms

• Healthy Elderly

Intervention

Drug:
• NX210c
3 times a week, for 28 days
• Placebo
3 times a week, for 28 days

Locations

Country	Name	City	State
Netherlands	Centre for Human Drug Research	Leiden	Zuid-Holland

Sponsors (2)

Lead Sponsor	Collaborator
Axoltis Pharma	Centre for Human Drug Research, Netherlands

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity and incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs)	Severity and incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs)	Up to 16 days after last dose