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

• Status: Completed
• Trial end date: 2019-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LegoChem Biosciences, Inc
• Treatments: Delpazolid; Linezolid; Oxazolidinones

Criteria

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