A Study of HM11260C in Healthy Male Subject

Study Overview
=================
Brief Summary
-----------------
Study Design: Randomized, double-blind, placebo-controlled, escalating single-dose design. Five ascending dose cohorts are planned.

Detailed Description
-----------------
Primary Objective: To assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single subcutaneous dose of HM11260C in healthy male subjects.

Official Title
-----------------
A Dose Block-randomized, Double-blind, Single Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of HM11260C After Subcutaneous Administration in Healthy Male Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: HM11260C
* Drug: HM11260C
* Drug: HM11260C
* Drug: HM11260C
* Drug: HM11260C


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male volunteers, age range 20 to 45 years Weight>50 and < 90kg, Body mass index of >18 and <27 Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study Exclusion Criteria Acute disease within 1 month prior to start of study drug administration Has previously disease which affect drug absorption, distribution, metabolism, excretion (e.g., inflammatory gastric disease, gastric or intestinal ulcer, hepatic disease, renal disease) History or presence of clinically significant and active cardiovascular, pulmonary, renal, endocrine, hematological, gastrointestinal, central nervous system, psychiatric disorder, autoimmune disease, or malignant tumor Has unsuitable clinical test results through the medical checkup, within 35 days prior to start of administration of study drug (medical history, physical examination, ECG, laboratory test) Laboratory test results AST (sGOT) or ALT (sGPT) > 1.25Xupper normal limit Total bilirubin > 1.5Xupper normal limit Absolute Neutrophil Count < 1500 mm2 History or presence of clinically significant allergic disease (including mild allergic rhinitis and allergic dermatitis which is not necessary to medication) Prior exposure to products related to Exenatide Use of any prescription medication within 14 days prior to Day 1 Use of any medication within 7 days prior to Day 1 (over-the-counter medication, herbal products, nutrient, vitamins) Subject who can't eat standard meal received by Korea University Anam Hospital Donor of whole blood for transfusion within 60 days prior to start of study drug administration or donor of apheresis within 20 days or Receiver of blood transfusion within 1 month Participation in another clinical study within 60 days prior to start of study drug administration Taking Caffein(> 5cups/ day) or alcohol abuse (> 30g/ day) or excessive smoker(> 10 Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort1<br>HM11260C 0.5mcg/kg or Placebo | Drug: HM11260C<br>* HM11260C 0.5mcg/kg or Placebo<br>|
| Experimental: Cohort2<br>HM11260C 2mcg/kg or Placebo | Drug: HM11260C<br>* HM11260C 2mcg/kg or Placebo<br>|
| Experimental: Cohort3<br>HM11260C 4mcg/kg or Placebo | Drug: HM11260C<br>* HM11260C 4mcg/kg or Placebo<br>|
| Experimental: Cohort4<br>HM11260C 8mcg/kg or Placebo | Drug: HM11260C<br>* HM11260C 8mcg/kg or Placebo<br>|
| Experimental: Cohort5<br>HM11260C 14mcg/kg or Placebo | Drug: HM11260C<br>* HM11260C 14mcg/kg or Placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Investigate Safety of HM10560A: Safety data, including physical examinations, laboratory evaluation, ECGs, vital signs, adverse events, and immunogenicity | 1, 2, 3, 4, 5, 7, 9, 16, 22, 30, 36, 43, 57, 84 Day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exendin-4