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

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ClinicalTrials.gov Identifier: NCT01737424
Recruitment Status : Completed
First Posted : November 29, 2012
Last Update Posted : March 14, 2014
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences

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

Condition or disease Intervention/treatment Phase
Healthy Drug: LC28-0126 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
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
Study Start Date : December 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo
Experimental: LC28-0126
LC28-0126(IV)
Drug: LC28-0126
LC28-0126



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

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


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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01737424


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

Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01737424     History of Changes
Other Study ID Numbers: LG-CYCL001
First Posted: November 29, 2012    Key Record Dates
Last Update Posted: March 14, 2014
Last Verified: March 2014