Clinical Trial: Safety, Tolerability and Pharmacokinetic Study of KL1333 in Healthy Male Volunteers
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: A Dose Block-randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation, Phase I Clinical Study
Brief Summary: The purpose of this First In Human study is to investigate the safety and tolerability of KL1333 after a single oral dose and to investigate the pharmacokinetic characteristics of KL1333 after a single oral dose.
Detailed Summary:
Sponsor: KT&G Life Sciences Corp
Current Primary Outcome: Number of reported adverse events [ Time Frame: from day 1 to day 15 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Maximum plasma concentration (Cmax) of KL1333 [ Time Frame: from day 1 to day 15 ]
- Area Under the Curve (AUC) of KL1333 [ Time Frame: from day 1 to day 15 ]
- Half-life (T1/2) of KL1333 [ Time Frame: from day 1 to day 15 ]
Original Secondary Outcome: Same as current
Information By: KT&G Life Sciences Corp
Dates:
Date Received: February 5, 2017
Date Started: March 1, 2017
Date Completion: September 1, 2017
Last Updated: February 14, 2017
Last Verified: February 2017
