A Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetic Characteristics of LC28-0126.

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: 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

Study Timeline

• Study Start: 2017-06-07
• Study First Submitted: 2017-06-20
• Study First Submitted QC: 2017-06-20
• Study First Posted: 2017-06-23
• Primary Completion: 2017-11-15
• Study Completion: 2017-11-15
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-10
• Last Update Posted: 2018-04-11

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