NCT02462031

To Evaluate the Safety, Tolerability, PK, PK-PD Relation of KD101 in the Fed State in Obese or Overweight Subjects

A Randomized, Double-blind, Placebo-controlled, Single or Multiple Ascending Dose Phase I Clinical Trial to Evaluate the Safety, Tolerability, PK, PK-PD Relation of KD101 in the Fed State in Obese or Overweight Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Kwang Dong Pharmaceutical co., ltd. · Industry
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To Evaluate the safety, tolerability and pharmacokinetic property after KD101 multiple oral dosing in the fed state in obese or overweight subjects.

Detailed description

dose block-randomized, double-blinded, placebo controlled, single or multiple ascending dose study. AEs, PE, Vital signs, ECGs and Clinical lab tests * Part I : multiple dose study (KD101 or placebo) / male and female * Part II : single dose study (KD101) / male only

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	KD101	200mg, 400mg, 800mg, 1400mg
DRUG	placebo	200mg, 400mg, 800mg

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-01-01
• Completion: 2016-03-01
• First posted: 2015-06-03
• Last updated: 2015-06-03

Locations

1 site across 1 country: South Korea