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

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

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.

Inclusion Criteria:

1. Age : 20 ~ 45 years old
2. Healthy Male
3. Body weight : ≥50kg and Ideal body weight ± 20%
4. Informed consent

Exclusion Criteria:

1. Clinically significant medical history
2. Acute or Chronic pancreatitis
3. Clinically significant hypersensitivity of Drugs
4. Clinically significant cutaneous disorder
5. History of administration of exenatide
6. Disorder of blood pressure
7. History of drug abuse