NCT01156779

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P50-P75 for phase_1 diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 2, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 5, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Last Updated

August 13, 2013

Status Verified

August 1, 2013

Enrollment Period

1.8 years

First QC Date

July 2, 2010

Last Update Submit

August 12, 2013

Conditions

Diabetes Mellitus

Keywords

SR-Exenatide

Outcome Measures

Primary Outcomes (1)

  • Assessment of safety

    1. Adverse Events 2. Laboratory Results 3. Vital sign, Physical Examination, EKG

    84 days

Secondary Outcomes (1)

  • Pharmacokinetics and Pharmacodynamics

    PK : 84 days / PD : 42days

Study Arms (2)

DA-3091

EXPERIMENTAL

SR-exenatide

Drug: SR-exenatide

Placebo of DA-3091

PLACEBO COMPARATOR

Placebo

Drug: SR-exenatide

Interventions

SR-exenatideDRUG

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

Also known as: DA-3091
DA-3091Placebo of DA-3091

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age : 20 \~ 45 years old
  • Healthy Male
  • Body weight : ≥50kg and Ideal body weight ± 20%
  • Informed consent

You may not qualify if:

  • Clinically significant medical history
  • Acute or Chronic pancreatitis
  • Clinically significant hypersensitivity of Drugs
  • Clinically significant cutaneous disorder
  • History of administration of exenatide
  • Disorder of blood pressure
  • History of drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Kyung-Sang Yu, M.D., Ph.d

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2010

First Posted

July 5, 2010

Study Start

July 1, 2010

Primary Completion

April 1, 2012

Last Updated

August 13, 2013

Record last verified: 2013-08

Locations

KR(1)