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Study of SPG302 in Healthy Volunteers and ALS Participants

NCT05882695 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2025-06-29

No results posted yet for this study

Summary

The first-in-human Phase 1 study described herein will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SPG302 in healthy volunteers and ALS participants

Conditions

Interventions

DRUG

SPG302

synthetic small molecule

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Novotech (Australia) Pty Limited

    collaborator INDUSTRY

  • Spinogenix

    lead INDUSTRY

Principal Investigators

  • Ofer M Gonen, MD · Nucleus Network (for healthy volunteers)

  • David Schultz (ALS site), MD · Finders Medical Center (ALS)

  • Robert Henderson (ALS site), MD · Royal Brisbane Hospital (ALS)

  • Dominic Rowe, MD · Macquarie Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-03
Primary Completion
2025-06-27
Completion
2025-06-27
FDA Drug
Yes

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT05882695 on ClinicalTrials.gov