This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by (Responsible Party):
LG Life Sciences Identifier:
First received: November 27, 2012
Last updated: March 13, 2014
Last verified: March 2014
To investigate the safety, tolerability and pharmacokinetic characteristics of LC28-0126 in healthy male subjects

Condition Intervention Phase
Healthy Drug: LC28-0126 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Dose Blocked-randomized, Double-blind, Placebo-controlled, Single Dosing and Dose-escalation Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetic Characteristics of LC28-0126 in Healthy Male Subjects

Further study details as provided by LG Life Sciences:

Primary Outcome Measures:
  • Adverse events [ Time Frame: 12 days ]

Secondary Outcome Measures:
  • Cmax [ Time Frame: up to 6 days post-dose ]
  • AUC [ Time Frame: up to 6 days post-dose ]

Enrollment: 89
Study Start Date: December 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Drug: Placebo
Experimental: LC28-0126
Drug: LC28-0126


Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01737424

Korea, Republic of
Seoul National University Hospital, Clinical Trial Center
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
LG Life Sciences
Principal Investigator: Kyung-Sang Yu, M.D., Ph.D. Seoul National University Hospital
  More Information

Responsible Party: LG Life Sciences Identifier: NCT01737424     History of Changes
Other Study ID Numbers: LG-CYCL001
Study First Received: November 27, 2012
Last Updated: March 13, 2014 processed this record on August 21, 2017