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

A Phase I Clinical Study, Randomized, Double-blind, Placebo-controlled, Single Dose, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCB01-0371 in Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01554995

Enrollment

Registered

2012-03-15

Start date

2012-03-31

Completion date

2013-02-28

Last updated

2014-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

LCB01-0371

Brief 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

Detailed 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

Interventions

DRUGLCB01-0371

LCB01-0371 50mg (Cohort 1) 100mg (Cohort 2) 200mg (Cohort 3) 400mg (Cohort 4) 600mg (Cohort 5)

DRUGLinezolid

Linezolid 600 mg (Cohort 9) none

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
safety and tolerability	7 days	Summary statistics for SAD parts will be prepared for measured values and changes from baseline values for each dose group. Placebo subjects will serve as the control. Summaries of treatment-emergent and clinically important abnormalities in ECG, physical examination, vital signs, and laboratory (clinical chemistry, hematology, coagulation, urinalysis) data will be provided. The incidence of adverse events(AEs) will be tabulated and compared across dose group in the SAD parts.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026