- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03196804
A Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetic Characteristics of LC28-0126.
April 10, 2018 updated by: LG Chem
A Dose Blocked-randomized, Double-blind, Placebo-controlled, Multiple Dosing and Dose-escalation Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetic Characteristics of LC28-0126 in Healthy Male Subjects
To assess the safety, tolerability and pharmacokinetic characteristics of LC-28-0126 multiple iv injection in healthy male subjects.
Study Overview
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 110-744
- Seoul National University Hospital, Clinical Trial Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LC28-0126
LC28-0126(IV)
|
LC28-0126
|
Placebo Comparator: Placebo
Placebo of LC28-0126
|
Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse events
Time Frame: 18 days
|
18 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cmax
Time Frame: up to 6 days post-dose
|
up to 6 days post-dose
|
AUC
Time Frame: up to 6 days post-dose
|
up to 6 days post-dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 7, 2017
Primary Completion (Actual)
November 15, 2017
Study Completion (Actual)
November 15, 2017
Study Registration Dates
First Submitted
June 20, 2017
First Submitted That Met QC Criteria
June 20, 2017
First Posted (Actual)
June 23, 2017
Study Record Updates
Last Update Posted (Actual)
April 11, 2018
Last Update Submitted That Met QC Criteria
April 10, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- LG-CYCL003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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