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

Dong-A Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus

Treatments: Drug: SR-exenatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01156779

DA3091_DM_I

Details and patient eligibility

About

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

Full 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.

Enrollment: 31 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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31 participants in 2 patient groups, including a placebo group

DA-3091

Experimental group

Description:

SR-exenatide

Treatment:

Drug: SR-exenatide

Placebo of DA-3091

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: SR-exenatide