A Study of HM11260C in Healthy Male Subject

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: HM11260C

• Registration Number: NCT01093729
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

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.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-03-23
• Study First Submitted QC: 2010-03-25
• Study First Posted: 2010-03-26
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2011-12
• Last Update Submitted: 2014-02-06
• Last Update Posted: 2014-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 41

Inclusion Criteria

1. Healthy male volunteers, age range 20 to 45 years
2. 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

1. Acute disease within 1 month prior to start of study drug administration

2. Has previously disease which affect drug absorption, distribution, metabolism, excretion (e.g., inflammatory gastric disease, gastric or intestinal ulcer, hepatic disease, renal disease)

3. History or presence of clinically significant and active cardiovascular, pulmonary, renal, endocrine, hematological, gastrointestinal, central nervous system, psychiatric disorder, autoimmune disease, or malignant tumor

4. 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)

5. Laboratory test results

   1. AST (sGOT) or ALT (sGPT) > 1.25Xupper normal limit
   2. Total bilirubin > 1.5Xupper normal limit
   3. Absolute Neutrophil Count < 1500 mm2

6. History or presence of clinically significant allergic disease (including mild allergic rhinitis and allergic dermatitis which is not necessary to medication)

7. Prior exposure to products related to Exenatide

8. Use of any prescription medication within 14 days prior to Day 1

9. Use of any medication within 7 days prior to Day 1 (over-the-counter medication, herbal products, nutrient, vitamins)

10. Subject who can't eat standard meal received by Korea University Anam Hospital

11. 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

12. Participation in another clinical study within 60 days prior to start of study drug administration

13. 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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort1	HM11260C	HM11260C 0.5mcg/kg or Placebo
Cohort2	HM11260C	HM11260C 2mcg/kg or Placebo
Cohort3	HM11260C	HM11260C 4mcg/kg or Placebo
Cohort5	HM11260C	HM11260C 14mcg/kg or Placebo
Cohort4	HM11260C	HM11260C 8mcg/kg or Placebo

Primary Outcome Measures

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