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

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Drug: SR-exenatide

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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Clinical Trial center, Clinical Research institute, Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DA-3091; SR-exenatide	Drug: SR-exenatide; Emulsion 0.5mg,1mg,2mg,4mg dosage (Dose-escalation) Single injection; Other Names: DA-3091
Placebo Comparator: Placebo of DA-3091; Placebo	Drug: SR-exenatide; Emulsion 0.5mg,1mg,2mg,4mg dosage (Dose-escalation) Single injection; Other Names: DA-3091

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of safety	Adverse Events; Laboratory Results; Vital sign, Physical Examination, EKG	84 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Dong-A Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): April 1, 2012
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: July 2, 2010
• First Submitted That Met QC Criteria: July 2, 2010
• First Posted (Estimate): July 5, 2010

Study Record Updates

• Last Update Posted (Estimate): August 13, 2013
• Last Update Submitted That Met QC Criteria: August 12, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: SR-Exenatide
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Obesity Agents; Incretins; Exenatide
• Other Study ID Numbers: DA3091_DM_I

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No