A Study of HM11260C in Healthy Male Subject

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: HM11260C; Drug: HM11260C; Drug: HM11260C; Drug: HM11260C; Drug: HM11260C

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: TRIPLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cohort1; HM11260C 0.5mcg/kg or Placebo	Drug: HM11260C; HM11260C 0.5mcg/kg or Placebo; Drug: HM11260C; HM11260C 2mcg/kg or Placebo; Drug: HM11260C; HM11260C 4mcg/kg or Placebo; Drug: HM11260C; HM11260C 8mcg/kg or Placebo; Drug: HM11260C; HM11260C 14mcg/kg or Placebo
EXPERIMENTAL: Cohort2; HM11260C 2mcg/kg or Placebo	Drug: HM11260C; HM11260C 0.5mcg/kg or Placebo; Drug: HM11260C; HM11260C 2mcg/kg or Placebo; Drug: HM11260C; HM11260C 4mcg/kg or Placebo; Drug: HM11260C; HM11260C 8mcg/kg or Placebo; Drug: HM11260C; HM11260C 14mcg/kg or Placebo
EXPERIMENTAL: Cohort3; HM11260C 4mcg/kg or Placebo	Drug: HM11260C; HM11260C 0.5mcg/kg or Placebo; Drug: HM11260C; HM11260C 2mcg/kg or Placebo; Drug: HM11260C; HM11260C 4mcg/kg or Placebo; Drug: HM11260C; HM11260C 8mcg/kg or Placebo; Drug: HM11260C; HM11260C 14mcg/kg or Placebo
EXPERIMENTAL: Cohort4; HM11260C 8mcg/kg or Placebo	Drug: HM11260C; HM11260C 0.5mcg/kg or Placebo; Drug: HM11260C; HM11260C 2mcg/kg or Placebo; Drug: HM11260C; HM11260C 4mcg/kg or Placebo; Drug: HM11260C; HM11260C 8mcg/kg or Placebo; Drug: HM11260C; HM11260C 14mcg/kg or Placebo
EXPERIMENTAL: Cohort5; HM11260C 14mcg/kg or Placebo	Drug: HM11260C; HM11260C 0.5mcg/kg or Placebo; Drug: HM11260C; HM11260C 2mcg/kg or Placebo; Drug: HM11260C; HM11260C 4mcg/kg or Placebo; Drug: HM11260C; HM11260C 8mcg/kg or Placebo; Drug: HM11260C; HM11260C 14mcg/kg or Placebo

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

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited
• Investigators: Principal Investigator: Hanmi Clinical, Korea

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (ACTUAL): October 1, 2010
• Study Completion (ACTUAL): October 1, 2010

Study Registration Dates

• First Submitted: March 23, 2010
• First Submitted That Met QC Criteria: March 25, 2010
• First Posted (ESTIMATE): March 26, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): February 7, 2014
• Last Update Submitted That Met QC Criteria: February 6, 2014
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Exendin-4
• Other Study ID Numbers: HM-EXC-101