Skip to main content
OpenTrials
Completed

NCT Number: NCT01156779

Study to Evaluate Safety and PK/PD of DA-3091 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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

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

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

SR-exenatide

Drug

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

Other names: DA-3091

Primary outcomes

  1. Assessment of safety

    Time frame: 84 days

    • Adverse Events
    • Laboratory Results
    • Vital sign, Physical Examination, EKG

Secondary outcomes

  1. Pharmacokinetics and Pharmacodynamics

    Time frame: PK : 84 days / PD : 42days

    PK : Cmax, Tmax, AUClast PD : Glucose, Insulin, Glucagon, C-peptide in blood sample

Sponsors and collaborators

Lead sponsor

Dong-A Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Acronym: SR-Exenatide

Important dates

Study start
2010
Primary completion
2012
First posted
Jul 5, 2010
Registry last updated
Aug 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.