A Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetic Characteristics of LC28-0126.
Sponsor
LG Chem (Industry)
Overall Status
Completed
CT.gov ID
NCT03196804
Collaborator
(none)
32
1
2
5.3
6
Study Details
Study Description
Brief Summary
To assess the safety, tolerability and pharmacokinetic characteristics of LC-28-0126 multiple iv injection in healthy male subjects.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
Double-blind
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date
:
Jun 7, 2017
Actual Primary Completion Date
:
Nov 15, 2017
Actual Study Completion Date
:
Nov 15, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: LC28-0126 LC28-0126(IV) |
Drug: LC28-0126
LC28-0126
|
| Placebo Comparator: Placebo Placebo of LC28-0126 |
Drug: Placebo
Placebo
|
Outcome Measures
Primary Outcome Measures
- Adverse events [18 days]
Secondary Outcome Measures
- Cmax [up to 6 days post-dose]
- AUC [up to 6 days post-dose]
Eligibility Criteria
Criteria
Ages Eligible for Study:
19 Years
to 45 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National University Hospital, Clinical Trial Center | Seoul | Korea, Republic of | 110-744 |
Sponsors and Collaborators
- LG Chem
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
LG Chem
ClinicalTrials.gov Identifier:
NCT03196804
Other Study ID Numbers:
- LG-CYCL003
First Posted:
Jun 23, 2017
Last Update Posted:
Apr 11, 2018
Last Verified:
Apr 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No