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

LG Chem

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: LC28-0126

Study type: Interventional

Funder types: Industry

Identifiers

NCT03196804

LG-CYCL003

Details and patient eligibility

About

To assess the safety, tolerability and pharmacokinetic characteristics of LC-28-0126 multiple iv injection in healthy male subjects.

Enrollment: 32 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups, including a placebo group

LC28-0126

Experimental group

Description:

LC28-0126(IV)

Treatment:

Drug: LC28-0126

Placebo

Placebo Comparator group

Description:

Placebo of LC28-0126

Treatment:

Drug: Placebo