Ignite Creation Date:
2024-05-06 @ 3:34 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04676711
Status:
COMPLETED
Last Update Posted:
2023-05-15
First Post:
2020-12-15
Brief Title:
A Study of GFH312 in Healthy Subjects
Sponsor:
GenFleet Therapeutics Australia Pty Ltd
Organization:
Genfleet Therapeutics Shanghai Inc
Study Overview
Official Title:
A First-in-human Randomized Double-blinded Placebo- Controlled Two-part Study to Assess SafetyTolerability and Pharmacokinetics of Single- and Multiple-ascending Doses and Food Effect of GFH312 in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
GFH312 is a small molecule inhibitor of receptor-interacting serinethreonine protein-1RIP1 kinase a key regulator of the TNF-α downstream RIPK1 can regulate the NF- κB signaling and necroptosis a type of cell death which can trigger immune response and enhance inflammation As such GFH312 represents a novel selective mechanism for the treatment of inflammatory conditions
This study is the first administration of GFH312 to humans The purpose of the study is to evaluate the safetytolerability and pharmacokinetics in healthy subjects The intention of this study is to provide confidence in the safety of the molecule to inform progression to further proof-of-concept studies The dose range proposed in this study is based on a low starting dose escalating to supra-therapeutic doses
This study is the first administration of GFH312 to humans The purpose of the study is to evaluate the safetytolerability and pharmacokinetics in healthy subjects The intention of this study is to provide confidence in the safety of the molecule to inform progression to further proof-of-concept studies The dose range proposed in this study is based on a low starting dose escalating to supra-therapeutic doses
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None