A Study of GFH312 in Healthy Subjects
- Registration Number
- NCT04676711
- Lead Sponsor
- GenFleet Therapeutics (Australia) Pty Ltd.
- Brief Summary
GFH312 is a small molecule inhibitor of receptor-interacting serine/threonine protein-1(RIP1) 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 safety/tolerability 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GFH312 GFH312 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Safety /Tolerability of GFH312 (adverse events) approximately 45 days Incidence of adverse events and serious adverse events
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Nucleus Network Pty Ltd
🇦🇺Melbourne, Victoria, Australia