Trials / Completed
CompletedNCT02882789
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
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- LigaChem Biosciences, Inc. · Industry
- Sex
- Male
- Age
- 19 Years – 39 Years
- Healthy volunteers
- Accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LCB01-0371 | Cohort1 \& 3: Placebo-controlled, Single ascending dose administration |
| DRUG | LCB01-0371 400mg | Cohort 2: Crossover designed administration |
Timeline
- Start date
- 2016-09-01
- Primary completion
- 2017-07-01
- Completion
- 2017-07-01
- First posted
- 2016-08-30
- Last updated
- 2018-04-10
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT02882789. Inclusion in this directory is not an endorsement.