Study to Investigate the Safety and Pharmacokinetic Characteristics of LC28-0126 in Healthy Male Subjects

LG Life Sciences

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LC28-0126; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01737424

LG-CYCL001

Details and patient eligibility

About

To investigate the safety, tolerability and pharmacokinetic characteristics of LC28-0126 in healthy male subjects

Enrollment: 89 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male subjects between the ages of 20 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 2 months
• Regular alcohol consumption >21 units per week.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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89 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

LC28-0126

Experimental group

Description:

LC28-0126(IV)

Treatment:

Drug: LC28-0126