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

Phase 1

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: SR-exenatide

• Registration Number: NCT01156779
• Lead Sponsor: Dong-A Pharmaceutical Co., Ltd.

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 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.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-02
• Study First Submitted QC: 2010-07-02
• Study First Posted: 2010-07-05
• Primary Completion: 2012-04
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-12
• Last Update Posted: 2013-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 31

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DA-3091	SR-exenatide	SR-exenatide
Placebo of DA-3091	SR-exenatide	Placebo

Primary Outcome Measures

Name	Time	Method
Assessment of safety	84 days	1. Adverse Events; 2. Laboratory Results; 3. Vital sign, Physical Examination, EKG

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics and Pharmacodynamics	PK : 84 days / PD : 42days	PK : Cmax, Tmax, AUClast PD : Glucose, Insulin, Glucagon, C-peptide in blood sample

Trial Locations

Locations (1)

Clinical Trial center, Clinical Research institute, Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of