A Phase II Clinical Study of LCB01-0371 to Evaluate the EBA, Safety and PK
NCT02836483 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 79
Last updated 2020-02-06
Summary
A Prospective, Randomized, Open, Active-controlled, Interventional, Exploratory, Phase II Trial of LCB01-0371.
Conditions
- Pulmonary Tuberculosis
Interventions
- 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
Sponsors & Collaborators
-
LigaChem Biosciences, Inc.
lead INDUSTRY
Principal Investigators
-
T.S Sim, M.D., Ph.D · Asan Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-12-10
- Primary Completion
- 2019-07-01
- Completion
- 2019-07-01
Countries
- South Korea
Study Locations
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