NCT04676711

A Study of GFH312 in Healthy Subjects

A First-in-human, Randomized, Double-blinded, Placebo- Controlled, Two-part Study to Assess Safety/Tolerability and Pharmacokinetics of Single- and Multiple-ascending Doses and Food Effect of GFH312 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: GenFleet Therapeutics (Australia) Pty Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Toxicity
• Healthy

Interventions

Type	Name	Description
DRUG	GFH312	Subjects are planned to be dosed in oral tablet, with single and multiple ascending doses
DRUG	Placebo	Subjects are planned to be dosed in oral tablet, with single and multiple ascending doses

Timeline

• Start date: 2021-04-27
• Primary completion: 2022-05-23
• Completion: 2022-10-31
• First posted: 2020-12-21
• Last updated: 2023-05-15

Locations

1 site across 1 country: Australia