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MAD Study of NX210c (CHDR2235)

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ClinicalTrials.gov Identifier: NCT05827653
Recruitment Status : Recruiting
First Posted : April 25, 2023
Last Update Posted : January 31, 2024
Sponsor:
Collaborator:
Centre for Human Drug Research, Netherlands
Information provided by (Responsible Party):
Axoltis Pharma

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

Condition or disease Intervention/treatment Phase
Healthy Elderly Drug: NX210c Drug: Placebo Phase 1

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

A double-blind, randomized, placebo-controlled, multiple ascending dose study to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamic effects of multiple intravenous infusions of NX210c. Two doses will be investigated.

Subjects will participate for approx. 124 days; up to 84 days for screening, 26 days of treatment and 14 days Follow-up. As part of the screening process subjects will undergo MRI and Mini-Mental State Examination to establish normal cognitive capacity and exclude any major neurological condition. Blood for PK will be drawn as well as for biomarkers testing. A CNS battery of pharmacodynamic measures including EEG and MRI will be performed, as well as Lumbar punctures for cerebrospinal fluid drug concentration determination and biomarker testing.

The study will be overseen by a safety review committee, sentinel dosing will be applied for each cohort. The rest of the cohort will be dosed if administration of NX210c is safe and well tolerated.
Masking: Double (Participant, Investigator)
Masking Description: Study is double-blind. Only personnel involved in randomization and creating reports to facilitate safe dose escalation, are planned to be unblinded during study.
Primary Purpose: Basic Science
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
Actual Study Start Date : December 5, 2022
Estimated Primary Completion Date : December 30, 2024
Estimated Study Completion Date : December 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1_active
Dose 1 NX210c
 Drug: NX210c
3 times a week, for 28 days
Experimental: Cohort 1_placebo
Placebo
 Drug: Placebo
3 times a week, for 28 days
Experimental: Cohort 2_active
Dose 2 (TBC) NX210c.
 Drug: NX210c
3 times a week, for 28 days
Experimental: Cohort 2_placebo
Placebo
 Drug: Placebo
3 times a week, for 28 days


Outcome Measures
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Primary Outcome Measures :
  1. Severity and incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs) [ Time Frame: 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)


Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05827653


Contacts
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Contact: Daniel Dumas, MD +31 71 5246 400 clintrials@chdr.nl

Locations
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Netherlands
Centre for Human Drug Research Recruiting
Leiden, Zuid-Holland, Netherlands, 2333 CL
Contact: Philip Kremer, MD, PharmD, PhD    +31 71 5246 400    clintrials@chdr.nl   
Sponsors and Collaborators
Axoltis Pharma
Centre for Human Drug Research, Netherlands
Investigators
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Principal Investigator: Philip Kremer, MD, PharmD, PhD Centre For Human Drug Research
More Information
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Responsible Party: Axoltis Pharma
ClinicalTrials.gov Identifier: NCT05827653    
Other Study ID Numbers: AXO-CLI-210c-02
2022-002868-76 ( EudraCT Number )
First Posted: April 25, 2023    Key Record Dates
Last Update Posted: January 31, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Anonymized subject data to be shared based on reasonable request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No