NCT05882695

Study of SPG302 in Healthy Volunteers and ALS Participants

A Phase 1/2a, Randomized, Double Blind, Placebo Controlled, Single and Multiple Dose Escalation Study in Healthy Volunteers and an Expansion Cohort in Adult Participants With Amyotrophic Lateral Sclerosis (ALS) to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPG302

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Spinogenix · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Detailed description

This study is a Phase 1 randomized, double-blind, placebo-controlled, single, and multiple ascending dose study in HV with food effect cohort, and a repeat dose expansion cohort(s) in participants with ALS. The study consists of 3 parts, as follows: * Part 1: SAD in HV with up to 6 cohorts including a food effect cohort. * Part 2: MAD over 5 days in HV with up to 5 cohorts * Part 3: ALS cohorts with once daily (QD) dosing over 28 day cycles

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
DRUG	SPG302	synthetic small molecule
DRUG	Placebo	Placebo

Timeline

• Start date: 2023-07-03
• Primary completion: 2025-06-27
• Completion: 2025-06-27
• First posted: 2023-05-31
• Last updated: 2025-06-29

Locations

4 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study