NCT03650075

To Determine Safety and Tolerability of MG-S-2525 and to Evaluate Its PK Profile in Healthy Volunteers

A Phase I Study to Determine Safety and Tolerability of MG-S-2525 and to Evaluate Its Pharmacokinetic Profile in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Metagone Biotech Inc. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

Summary

This is a Phase I stage to investigate the safety and tolerability of MG-S-2525 in healthy volunteers. The proposed trial consists of 3 study parts to be conducted at Tri-Service General Hospital and includes Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and Food Effect parts. This study will enroll up to 16 evaluable subjects in the SAD part, 36 evaluable subjects in the MAD part and enroll up to 20 evaluable subjects for the Food Effect part.

Conditions

• Idiopathic Pulmonary Fibrosis (IPF)

Interventions

Type	Name	Description
DRUG	MG-S-2525	The investigational product is MG-S-2525, which is an oral, small-molecule, anti-inflammatory agent. MG-S-2525 is being developed by Metagone Biotech Inc. and contains the new molecular entity HL0, an inhibitor of MAP3K19 which is up-regulated in disease pathobiology and in response to inflammatory stimuli in IPF.

Timeline

• Start date: 2019-02-25
• Primary completion: 2019-12-31
• Completion: 2020-02-27
• First posted: 2018-08-28
• Last updated: 2020-09-02

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated drug study