IV Dosage Form of LCB01-0371 Phase I Study in Healthy Male Volunteers

A Randomized, Single Blind, Single Dose, Phase I Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Intravenous Dosage Form of LCB01-0371 in Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02882789

Enrollment

Registered

2016-08-30

Start date

2016-09-30

Completion date

2017-07-31

Last updated

2018-04-10

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

Conditions

Healthy

Brief summary

Primary - To investigate the Pharmacokinetics, Safety, and Tolerability of Intravenous dosage form of LCB01-0371 comparing to oral dosage in Healthy Male Volunteers Secondary • To investigate the absolute bio availability of LCB01-0371 after a single intravenous dose

Interventions

DRUGLCB01-0371

Cohort1 & 3: Placebo-controlled, Single ascending dose administration

DRUGLCB01-0371 400mg

Cohort 2: Crossover designed administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

19 Years to 39 Years

Healthy volunteers

Yes

Inclusion criteria

1. Healthy Male between 19 and 39 years of age at the time of screening 2. Subjects with body mass index (BMI) between 19 and 27 at the time of screening 3. Agree to continue to use a medically reliable dual contraception and not to donate sperm until 28 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 gastrointestinal problem (e.g. Crohn's disease, gastro-intestinal ulcer) which is affect to absorption OR surgical history except appendectomy, herniotomy 2. History of allergy, cardiovascular, peripheral vascular, skin, mucous membrane, eyes, otorhinolaryngologic, respiratory, musculoskeletal, infectious disease, gastroenterologic, liver, billiary, endocrinologic, kidney, genitourinary, neuropsychiatric, hemato-oncologic problem(s) or fracture etc.

Design outcomes

Primary

Measure	Time frame
To assess Peak Plasma Concentration(Cmax) of LCB01-0371	through study completion per patient, an average of 8 days (+ - 1 D)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026