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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01156779

Acronym

SR-Exenatide

Enrollment

Registered

2010-07-05

Start date

2010-07-31

Completion date

Unknown

Last updated

2013-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

SR-Exenatide

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.

Interventions

DRUGSR-exenatide

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Assessment of safety	84 days	1. Adverse Events 2. Laboratory Results 3. Vital sign, Physical Examination, EKG

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026