NCT02836483

A Phase II Clinical Study of LCB01-0371 to Evaluate the EBA, Safety and PK

A Prospective, Randomized, Open, Active-controlled, Interventional, Exploratory, Phase II Trial to Evaluate the EBA, Safety and PK of Orally Administered LCB01-0371 in Adult Patients With Smear-positive Pulmonary Tuberculosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: LigaChem Biosciences, Inc. · Industry
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Prospective, Randomized, Open, Active-controlled, Interventional, Exploratory, Phase II Trial of LCB01-0371.

Detailed description

This study is designed to explore antituberculosis of LCB01-0371 through the assess of the early bactericidal activity, safety of administration.

Conditions

• Pulmonary Tuberculosis

Interventions

Type	Name	Description
DRUG	LCB01-0371 800mg, QD	Oral administration
DRUG	LCB01-0371 400mg, BID	Oral administration
DRUG	LCB01-0371 800mg, BID	Oral administration
DRUG	Tubes 3~5Tablet, QD	Oral administration
DRUG	Zyvox 600mg, BID	Oral administration
DRUG	LCB01-0371 1200mg, QD	Oral administration

Timeline

• Start date: 2016-12-10
• Primary completion: 2019-07-01
• Completion: 2019-07-01
• First posted: 2016-07-19
• Last updated: 2020-02-06

Locations

1 site across 1 country: South Korea