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

LigaChem Biosciences

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LCB01-0371; Drug: LCB01-0371 400mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02882789

LCB01-0371-16-1-01

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: Male

Ages: 19 to 39 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 3 patient groups

LCB01-0371 200mg

Experimental group

Description:

LCB01-0371 IV 200 mg

Treatment:

Drug: LCB01-0371

LCB01-0371 400mg

Experimental group

Description:

LCB01-0371 IV 400 mg

Treatment:

Drug: LCB01-0371 400mg

Drug: LCB01-0371

LCB01-0371 800mg

Experimental group

Description:

LCB01-0371 IV 800 mg

Treatment:

Drug: LCB01-0371