A Clinical Study, Randomized, Double-blind, Placebo-controlled, Single Dose Study

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

Primary

• To investigate the safety and tolerability of LCB01-0371 after a single oral dose

Secondary

• To investigate the pharmacokinetic characteristics of LCB01-0371 after a single oral dose

• To investigate the safety of LCB01-0371 after a single oral dose

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

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

Criteria

Inclusion Criteria:

1. Healthy Male between 20 and 45 years of age at the time of screening

2. Subjects with body mass index (BMI) between 20 and 27 at the time of screening

3. Agree to continue to use a medically reliable dual contraception and not to donate sperm until 30th days of study completion

4. Capable of giving written informed consent, willing to participate in this clinical trial, and willing to comply with all study requirements

Exclusion Criteria:

1. History of liver, kidney, respiratory, musculoskeletal, endocrinologic, neuropsychiatric, hemato-oncologic, or cardiovascular problem(s).

2. History of gastrointestinal problem (e.g. Crohn's disease, gastro-intestinal ulcer) which is affect to absorption within 6 months from screening

3. History of hypersensitivity or clinically significant adverse drug reaction(s) to the LCB01-0371, same class of the study drugs (linezolid), or other drugs including aspirin and antibiotics.

4. History of drug abuse or positive result at urine drug screening test

5. AST, ALT, r-GT, billirubin(total) values over than 1.5 times of ULN