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

NCT03650075 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2020-09-02

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Metagone Biotech Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-25
Primary Completion
2019-12-31
Completion
2020-02-27
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03650075 on ClinicalTrials.gov