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

LigaChem Biosciences

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: LCB01-0371

Drug: Linezolid

Study type

Interventional

Funder types

Industry

Identifiers

LCB01-0371-11-1-01

Details and patient eligibility

About

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

Full description

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

Enrollment

70 patients

Sex

Male

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy Male between 20 and 45 years of age at the time of screening
Subjects with body mass index (BMI) between 20 and 27 at the time of screening
Agree to continue to use a medically reliable dual contraception and not to donate sperm until 30th days of study completion
Capable of giving written informed consent, willing to participate in this clinical trial, and willing to comply with all study requirements

Exclusion criteria

History of liver, kidney, respiratory, musculoskeletal, endocrinologic, neuropsychiatric, hemato-oncologic, or cardiovascular problem(s).
History of gastrointestinal problem (e.g. Crohn's disease, gastro-intestinal ulcer) which is affect to absorption within 6 months from screening
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.
History of drug abuse or positive result at urine drug screening test
AST, ALT, r-GT, billirubin(total) values over than 1.5 times of ULN