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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LCB01-0371; Drug: LCB01-0371 400mg

• Registration Number: NCT02882789
• Lead Sponsor: LigaChem Biosciences, Inc.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-09
• Study First Submitted QC: 2016-08-24
• Study First Posted: 2016-08-30
• Study Start: 2016-09
• Status Verified: 2017-03
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Last Update Submitted: 2018-04-09
• Last Update Posted: 2018-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LCB01-0371 400mg	LCB01-0371 400mg	LCB01-0371 IV 400 mg
LCB01-0371 800mg	LCB01-0371	LCB01-0371 IV 800 mg
LCB01-0371 200mg	LCB01-0371	LCB01-0371 IV 200 mg
LCB01-0371 400mg	LCB01-0371	LCB01-0371 IV 400 mg

Primary Outcome Measures

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

Trial Locations

Locations (1)

Bae KS; 🇰🇷 Seoul, Korea, Republic of