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

Diabetes Mellitus Clinical Trial

— SR-Exenatide  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01156779
• Other study ID #: DA3091_DM_I
• Status: Completed
• Phase: Phase 1
• First received: July 2, 2010
• Last updated: August 12, 2013
• Start date: July 2010

Study information

• Verified date: August 2013
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• SR-exenatide
Emulsion 0.5mg,1mg,2mg,4mg dosage (Dose-escalation) Single injection

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trial center, Clinical Research institute, Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of safety	Adverse Events; Laboratory Results; Vital sign, Physical Examination, EKG	84 days	No
Secondary	Pharmacokinetics and Pharmacodynamics	PK : Cmax, Tmax, AUClast PD : Glucose, Insulin, Glucagon, C-peptide in blood sample	PK : 84 days / PD : 42days	No