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AXER-204 in Participants With Chronic Spinal Cord Injury

NCT03989440 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2023-08-22

Study results available
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Summary

This two-part trial will assess the safety, tolerability, pharmacokinetics, and efficacy of AXER-204 administered by lumbar puncture and slow bolus infusion. Part 1 will evaluate the safety, tolerability, and pharmacokinetics of single ascending doses of AXER-204. Part 2 will evaluate the safety, tolerability, pharmacokinetics, and efficacy of repeated doses AXER-204 in comparison to placebo.

Conditions

  • Chronic Spinal Cord Injury

Interventions

DRUG

AXER-204

human NoGo Trap fusion protein

DRUG

Placebo

Phosphate buffered saline formulation

Sponsors & Collaborators

  • ReNetX Bio, Inc.

    lead INDUSTRY

Principal Investigators

  • George Maynard, PhD · ReNetX Bio

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-16
Primary Completion
2022-06-21
Completion
2022-06-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03989440 on ClinicalTrials.gov