Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06597799
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
First-in-human Study of MRT-6160 in Healthy Subjects
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase 1 First-in-Human Randomized Double-Blind Placebo-Controlled Single Ascending Dose Multiple Ascending Dose and Food-Effect Study to Assess Safety Tolerability PK and PD of MRT-6160 in Healthy Subjects
Status:
RECRUITING
Status Verified Date:
2024-09
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:
The principal aim of this study is to obtain safety and tolerability data when MRT-6160 is administered orally as single and multiple doses to healthy subjects This information together with the pharmacokinetic PK data will help establish the doses and dosing regimen suitable for future studies in patients
The study drug MRT-6160 is experimental This is the first study in which MRT-6160 will be given to humans
Part 1 Subjects will receive a single oral dose of MRT-6160 or placebo on Day 1
Part 2 Subjects will receive multiple oral doses of MRT-6160 or placebo for 7 consecutive days
The study drug MRT-6160 is experimental This is the first study in which MRT-6160 will be given to humans
Part 1 Subjects will receive a single oral dose of MRT-6160 or placebo on Day 1
Part 2 Subjects will receive multiple oral doses of MRT-6160 or placebo for 7 consecutive days
Detailed Description:
Detailed Description
The purpose of this study is to
Learn about the safety and tolerability of single and multiple ascending oral doses of MRT-6160 in healthy adult subjects
The purpose of this study is to
Learn about the safety and tolerability of single and multiple ascending oral doses of MRT-6160 in healthy adult subjects
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