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Study of SPG302 in Healthy Volunteers and ALS Participants

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:
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

Clinical Trial 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

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05882695
Study type Interventional
Source Spinogenix
Contact Public queries for healthy volunteers
Phone +61 1800 243 733
Email melbourne@nucleusnetwork.com
Status Recruiting
Phase Phase 1
Start date July 3, 2023
Completion date December 2025
View Details
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