MAD Study of NX210c

NCT05827653 | Completed Phase 1 DMC

• 2 other identifiers: AXO-CLI-210c-022022-002868-76
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Elderly

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Cohort 1_active

EXPERIMENTAL

Dose 1 NX210c

Drug: NX210c

Cohort 1_placebo

EXPERIMENTAL

Placebo

Drug: Placebo

Cohort 2_active

EXPERIMENTAL

Dose 2 (TBC) NX210c.

Drug: NX210c

Cohort 2_placebo

EXPERIMENTAL

Placebo

Drug: Placebo

Interventions

NX210c DRUG

3 times a week, for 28 days

Cohort 1_active; Cohort 2_active

Placebo DRUG

3 times a week, for 28 days

Cohort 1_placebo; Cohort 2_placebo

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Axoltis Pharma: lead
• Centre for Human Drug Research, Netherlands: collaborator

Study Sites (1)

Centre for Human Drug Research

Leiden, South Holland, 2333 CL, Netherlands

Location

Study Officials

• Philip Kremer, MD, PharmD, PhD

  Centre For Human Drug Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Study is double-blind. Only personnel involved in randomization and creating reports to facilitate safe dose escalation, are planned to be unblinded during study.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: April 25, 2023
• Study Start: December 5, 2022
• Primary Completion: April 29, 2023
• Study Completion: October 2, 2023
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)