A Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetic Characteristics of LC28-0126.
- Registration Number
- NCT03196804
- Lead Sponsor
- LG Chem
- Brief Summary
To assess the safety, tolerability and pharmacokinetic characteristics of LC-28-0126 multiple iv injection in healthy male subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 32
Inclusion Criteria
- Healthy male subjects between the ages of 19 and 45 years at screening.
- Subjects with BMI between 18.0(inclusive) and 27.0 kg/m2 (exclusive); and a total body weight between 55 kg (inclusive) and 90 kg (exclusive)
Exclusion Criteria
- Participation in a clinical research study within the previous 3 months
- Regular alcohol consumption >21 units per week.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo of LC28-0126 LC28-0126 LC28-0126 LC28-0126(IV)
- Primary Outcome Measures
Name Time Method Adverse events 18 days
- Secondary Outcome Measures
Name Time Method Cmax up to 6 days post-dose AUC up to 6 days post-dose
Trial Locations
- Locations (1)
Seoul National University Hospital, Clinical Trial Center
🇰🇷Seoul, Korea, Republic of