NCT01348516

Single Ascending Dose (SAD)/Multiple Ascending Dose(MAD) Safety/Pharmacokinetic (PK) Study of KM-023

A Dose Block-randomized, Double-blind, Placebo-controlled, Single/Multiple Dosing, Dose-escalation Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetic Characteristics of KM-023 After Oral Administration in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Kainos Medicine Inc. · Industry
• Sex: All
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the safety and pharmacokinetics of KM-023 after single/multiple dosing.

Conditions

• Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	KM-023	-KM-023 is dosed orally via 75 mg tablets. Study doses are 75 mg, 150 mg, 300 mg, and 600 mg QD for 1 (SAD) or 7 (MAD) days.
DRUG	Placebo for KM-023	-Placebo for KM-023 is dosed orally via Placebo for KM-023 tablets. Study doses are 1, 2, 3, and 4 placebo tablets QD for 1 (SAD) or 7 (MAD) days.

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-03-01
• First posted: 2011-05-05
• Last updated: 2012-07-26

Locations

1 site across 1 country: South Korea