Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2025-12-24 @ 1:36 PM
NCT ID:
NCT05882695
Brief 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
Study:
NCT05882695
Study Brief:
Protocol Section:
NCT05882695