Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06556394
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
A Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of RAG-17 in Subjects With Amyotrophic Lateral Sclerosis ALS With Superoxide Dismutase Type 1 SOD1 Gene Mutation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Safety TolerabilityPharmacokinetics and Pharmacodynamics of RAG-17 in Subjects With Amyotrophic Lateral Sclerosis ALS With Superoxide Dismutase Type 1 SOD1 Gene Mutation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 1 Randomized Double-Blind Placebo-Controlled Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of RAG-17 in Subjects with Amyotrophic Lateral Sclerosis ALS with Superoxide Dismutase Type 1 SOD1 Gene Mutation
Detailed Description:
The study is a phase 1 randomized double-blind placebo controlled study to evaluate the safety tolerability pharmacokinetics and pharmacodynamics of RAG-17 in patients with Amyotrophic Lateral Sclerosis ALS with Superoxide Dismutase Type 1 SOD1 gene mutation The dose levels will be evaluated sequentially across separate cohorts using a rules-based design wherein participants will receive RAG-17 or placebo at a ratio of 31
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None