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AXER-204 for Spinal Cord Injury (RESET Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by ReNetX Bio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up part 1: pre-dose and 1 h, 6 h, 12 h, and 24 h post-dose, day 4, 8, 15, and 29, part 2: pre-dose and 4 h post-dose on days 1, 21, 42, 63, and 104; and on study days 169 and 253.
Awards & highlights

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.

Eligible Conditions
  • Spinal Cord Injury

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part 1: pre-dose and 1 h, 6 h, 12 h, and 24 h post-dose, day 4, 8, 15, and 29, part 2: pre-dose and 4 h post-dose on days 1, 21, 42, 63, and 104; and on study days 169 and 253.
This trial's timeline: 3 weeks for screening, Varies for treatment, and part 1: pre-dose and 1 h, 6 h, 12 h, and 24 h post-dose, day 4, 8, 15, and 29, part 2: pre-dose and 4 h post-dose on days 1, 21, 42, 63, and 104; and on study days 169 and 253. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Volume of Distribution
Secondary study objectives
Change in Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP) Bilateral Prehension Performance Score
Change in International Standards for Neurological Classification of SCI (ISNCSCI) Bilateral Upper Extremity Motor Score (UEMS)
Change in Version III of the Spinal Cord Independence Measure (SCIM III) Self-care
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AXER-204Experimental Treatment1 Intervention
Part 1 - Single ascending doses; Part 2 - Repeated dose
Group II: PlaceboPlacebo Group1 Intervention
Part 2 only - Repeated dose

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Who is running the clinical trial?

ReNetX Bio, Inc.Lead Sponsor
George Maynard, PhDStudy DirectorReNetX Bio
~9 spots leftby Sep 2025
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