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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01156779
Recruitment Status : Completed
First Posted : July 5, 2010
Last Update Posted : August 13, 2013
Information provided by (Responsible Party):
Dong-A ST Co., Ltd. ( Dong-A Pharmaceutical Co., Ltd. )

July 2, 2010
July 5, 2010
August 13, 2013
July 2010
April 2012   (Final data collection date for primary outcome measure)
Assessment of safety [ Time Frame: 84 days ]
  1. Adverse Events
  2. Laboratory Results
  3. Vital sign, Physical Examination, EKG
Same as current
Complete list of historical versions of study NCT01156779 on Archive Site
Pharmacokinetics and Pharmacodynamics [ Time Frame: PK : 84 days / PD : 42days ]
PK : Cmax, Tmax, AUClast PD : Glucose, Insulin, Glucagon, C-peptide in blood sample
Same as current
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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.
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetes Mellitus
Drug: SR-exenatide
Emulsion 0.5mg,1mg,2mg,4mg dosage (Dose-escalation) Single injection
Other Name: DA-3091
  • Experimental: DA-3091
    Intervention: Drug: SR-exenatide
  • Placebo Comparator: Placebo of DA-3091
    Intervention: Drug: SR-exenatide
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
April 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
20 Years to 45 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
Not Provided
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Dong-A ST Co., Ltd. ( Dong-A Pharmaceutical Co., Ltd. )
Dong-A Pharmaceutical Co., Ltd.
Not Provided
Principal Investigator: Kyung-Sang Yu, M.D., Ph.d Seoul National University Hospital
Dong-A ST Co., Ltd.
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP