NCT01156779

Study to Evaluate Safety and PK/PD of DA-3091 in Healthy Male Subjects

A Dose Block-randomized, Double-blind, Placebo-controlled, Dose-escalating, Phase I Study to Evaluate Safety and Pharmacokinetics/Pharmacodynamics of DA-3091 After Subcutaneous Injection in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Dong-A Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This Phase I clinical study is to evaluate the safety and tolerance of DA-3091 and to characterize the pharmacokinetic/pharmacodynamic of DA-3091 in healthy male subjects

Detailed description

This is a phase I dose escalation study. To meet the clinical objectives, we are using a two-part approach. In part I, 4 subjects are injected 0.5mg dose of DA-3091 or placebo(Single/Subcutaneous Injection). After completion of part I study, we are reporting data about safety to IDMC. In part II, 8 subjects per group are injected 1mg, 2mg, 4mg of DA-3091 or placebo through dose escalating protocol. The ratio of DA-3091 and placebo is 3:1.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	SR-exenatide	Emulsion 0.5mg,1mg,2mg,4mg dosage (Dose-escalation) Single injection

Timeline

• Start date: 2010-07-01
• Primary completion: 2012-04-01
• First posted: 2010-07-05
• Last updated: 2013-08-13

Locations

1 site across 1 country: South Korea