MAD Study of NX210c

Phase 1

Completed

• Conditions: Healthy Elderly
• Interventions: Drug: Placebo; Drug: NX210c

• Registration Number: NCT05827653
• Lead Sponsor: Axoltis Pharma

Brief 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.

Study Timeline

• Study Start: 2022-12-05
• Study First Submitted: 2022-12-08
• Study First Submitted QC: 2023-04-12
• Study First Posted: 2023-04-25
• Primary Completion: 2023-04-29
• Study Completion: 2023-10-02
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1_placebo	Placebo	Placebo
Cohort 2_placebo	Placebo	Placebo
Cohort 2_active	NX210c	Dose 2 (TBC) NX210c.
Cohort 1_active	NX210c	Dose 1 NX210c

Primary Outcome Measures

Name	Time	Method
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	Severity and incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs)

Trial Locations

Locations (1)

Centre for Human Drug Research; 🇳🇱 Leiden, Zuid-Holland, Netherlands