Multiple Ascending Dose, Phase 1 Clinical Study of LCB01-0371

LigaChem Biosciences

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LCB01-0371 800mg BID; Drug: LCB01-0371 1200mg BID; Drug: LCB01-0371 800mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02540460

LCB01-0371-14-1-01

Details and patient eligibility

About

The purpose of this study is to investigate the population pharmacokinetics of LCB01-0371 after a multiple oral dose in healthy male subjects.

To investigate safety, tolerability of LCB01-0371 after a multiple oral dose in healthy male subjects.

Full description

Double blind, randomized, placebo control, multiple dose, dose escalation study

Enrollment: 30 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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 kg/m2 and 27 kg/m2 at the time of screening
3. Agree to continue to use a medically reliable dual contraception and not to donate sperm until 30th days after 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, alimentary, respiratory, musculoskeletal, endocrine, neuropsychiatric, hemato-oncologic, cardiovascular problem(s)
2. History of gastrointestinal problem (e.g. Crohn's disease, gastro-intestinal ulcer) within 6 months possibly affecting absorption of clinical trial drugs, or history of surgery (except simple appendectomy and herniotomy)
3. History of hypersensitivity reaction or history of clinically significant hypersensitivity reaction to LCB01-0371 or 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
5. AST, ALT, r-GT, bilirubin(total) values over than 1.5 times of ULN

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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30 participants in 4 patient groups, including a placebo group

LCB01-0371 800mg

Experimental group

Description:

LCB01-0371 800mg

Treatment:

Drug: Placebo

Drug: LCB01-0371 800mg

LCB01-0371 800mg BID

Experimental group

Description:

LCB01-0371 800mg BID

Treatment:

Drug: Placebo

Drug: LCB01-0371 800mg BID

LCB01-0371 1200mg BID

Experimental group

Description:

LCB01-0371 1200mg BID

Treatment:

Drug: Placebo

Drug: LCB01-0371 1200mg BID

Placebo

Placebo Comparator group

Description:

LCB01-0371 800mg, LCB01-0371 800mg BID, LCB01-0371 1200mg BID

Treatment:

Drug: Placebo