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

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

Study Overview

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

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; LCB01-0371 800mg, QD	Drug: LCB01-0371 800mg, QD; Oral administration; Other Names: LCB01-0371
Experimental: Group 2; LCB01-0371 400mg, BID	Drug: LCB01-0371 400mg, BID; Oral administration; Other Names: LCB01-0371
Experimental: Group 3; LCB01-0371 800mg, BID	Drug: LCB01-0371 800mg, BID; Oral administration; Other Names: LCB01-0371
Active Comparator: Group 4; Tubes 3~5Tablet, QD	Drug: Tubes 3~5Tablet, QD; Oral administration; Other Names: Tubes Tablet
Active Comparator: Group 5; Zyvox 600mg, BID	Drug: Zyvox 600mg, BID; Oral administration; Other Names: Zyvox Tablet
Experimental: Group 6; LCB01-0371 1200mg, QD	Drug: LCB01-0371 1200mg, QD; Oral administration; Other Names: LCB01-0371

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: LegoChem Biosciences, Inc
• Investigators: Principal Investigator: T.S Sim, M.D., Ph.D, Asan Medical Center

Publications and helpful links

General Publications

• Kim JS, Kim YH, Lee SH, Kim YH, Kim JW, Kang JY, Kim SK, Kim SJ, Kang YS, Kim TH, Mok J, Byun MK, Park HJ, Joh JS, Park YB, Lim HS, Choi H, Lee SH, Kim H, Yang J, Kim H, Shen X, Alsultan A, Cho I, Geiter L, Shim TS. Early Bactericidal Activity of Delpazolid (LCB01-0371) in Patients with Pulmonary Tuberculosis. Antimicrob Agents Chemother. 2022 Feb 15;66(2):e0168421. doi: 10.1128/AAC.01684-21. Epub 2021 Dec 6.

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2016
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: July 5, 2016
• First Submitted That Met QC Criteria: July 18, 2016
• First Posted (Estimate): July 19, 2016

Study Record Updates

• Last Update Posted (Actual): February 6, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Tuberculosis, Pulmonary; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Linezolid; Delpazolid; Oxazolidinones
• Other Study ID Numbers: LCB01-0371-15-2-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO