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

Phase 2

Completed

• Conditions: Pulmonary Tuberculosis
• Interventions: Drug: LCB01-0371 800mg, QD; Drug: LCB01-0371 1200mg, QD; Drug: Zyvox 600mg, BID; Drug: LCB01-0371 400mg, BID; Drug: LCB01-0371 800mg, BID; Drug: Tubes 3~5Tablet, QD

• Registration Number: NCT02836483
• Lead Sponsor: LigaChem Biosciences, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2016-07-05
• Study First Submitted QC: 2016-07-18
• Study First Posted: 2016-07-19
• Study Start: 2016-12-10
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

1. Korean who After listening to understand the details about the clinical trial, decided to join in the clinical study, and written consent
2. The age of consent at the time of writing, only men and women under 75 years old over 19 years old
3. The First diagnosis of tuberculosis and have not received tuberculosis treatment for TB patients

Exclusion Criteria

1. Known history of Rifampicin or Isoniazid resistance
2. Serious TB for example tuberculous encephalomeningitis, It is impossible to participate in clinical trials
3. Known History of nontuberculous mycobacteria positive
4. Other pulmonary disease which is impossible to participate in clinical trial except TB

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	LCB01-0371 800mg, QD	LCB01-0371 800mg, QD
Group 6	LCB01-0371 1200mg, QD	LCB01-0371 1200mg, QD
Group 5	Zyvox 600mg, BID	Zyvox 600mg, BID
Group 2	LCB01-0371 400mg, BID	LCB01-0371 400mg, BID
Group 3	LCB01-0371 800mg, BID	LCB01-0371 800mg, BID
Group 4	Tubes 3~5Tablet, QD	Tubes 3\~5Tablet, QD

Primary Outcome Measures

Name	Time	Method
EBA0-14	V2(Baseline, Day 1), V9(Day 15)	The extended early bactericidal activity (extended EBA) expressed as the change of log colony forming units of sputum from baseline at Day 15

Secondary Outcome Measures

Name	Time	Method
EBA2-14	V4(Day 3), V9(Day 15)	The extended early bactericidal activity (extended EBA) expressed as the change of log colony forming units of sputum from Day 3 at Day 15
EBA2-7	V4(Day 3), V6(Day 8)	The extended early bactericidal activity (extended EBA) expressed as the change of log colony forming units of sputum from Day 2 at Day 8
EBA0-2	V2(Baseline, Day 1), V4(Day 3)	The standard early bactericidal activity (standard EBA) expressed as the change of log colony forming units of sputum from baseline at Day 3

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of