Status:
COMPLETED
Study to Evaluate Safety and PK/PD of DA-3091 in Healthy Male Subjects
Lead Sponsor:
Dong-A Pharmaceutical Co., Ltd.
Conditions:
Diabetes Mellitus
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief 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 Inje...
Eligibility Criteria
Inclusion
- Age : 20 \~ 45 years old
- Healthy Male
- Body weight : ≥50kg and Ideal body weight ± 20%
- Informed consent
Exclusion
- Clinically significant medical history
- Acute or Chronic pancreatitis
- Clinically significant hypersensitivity of Drugs
- Clinically significant cutaneous disorder
- History of administration of exenatide
- Disorder of blood pressure
- History of drug abuse
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01156779
Start Date
July 1 2010
Last Update
August 13 2013
Active Locations (1)
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1
Clinical Trial center, Clinical Research institute, Seoul National University Hospital
Seoul, South Korea