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

NCT ID: NCT01156779

Last Updated: 2013-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus

Keywords

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SR-Exenatide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DA-3091

SR-exenatide

Group Type EXPERIMENTAL

SR-exenatide

Intervention Type DRUG

Emulsion 0.5mg,1mg,2mg,4mg dosage (Dose-escalation) Single injection

Placebo of DA-3091

Placebo

Group Type PLACEBO_COMPARATOR

SR-exenatide

Intervention Type DRUG

Emulsion 0.5mg,1mg,2mg,4mg dosage (Dose-escalation) Single injection

Interventions

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SR-exenatide

Emulsion 0.5mg,1mg,2mg,4mg dosage (Dose-escalation) Single injection

Intervention Type DRUG

Other Intervention Names

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DA-3091

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Dong-A Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyung-Sang Yu, M.D., Ph.d

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Clinical Trial center, Clinical Research institute, Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DA3091_DM_I

Identifier Type: -

Identifier Source: org_study_id