A Study of HM11260C in Healthy Male Subject

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01093729
First received: March 23, 2010
Last updated: February 6, 2014
Last verified: December 2011
  Purpose

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


Condition Intervention Phase
Healthy
Drug: HM11260C
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by Hanmi Pharmaceutical Company Limited:

Primary Outcome Measures:
  • Safety [ Time Frame: 1, 2, 3, 4, 5, 7, 9, 16, 22, 30, 36, 43, 57, 84 Day ] [ Designated as safety issue: Yes ]
    Investigate Safety of HM10560A: Safety data, including physical examinations, laboratory evaluation, ECGs, vital signs, adverse events, and immunogenicity


Enrollment: 41
Study Start Date: February 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort1
HM11260C 0.5mcg/kg or Placebo
Drug: HM11260C
HM11260C 0.5mcg/kg or Placebo
Other Name: HM11260C
Experimental: Cohort2
HM11260C 2mcg/kg or Placebo
Drug: HM11260C
HM11260C 2mcg/kg or Placebo
Other Name: HM11260C
Experimental: Cohort3
HM11260C 4mcg/kg or Placebo
Drug: HM11260C
HM11260C 4mcg/kg or Placebo
Other Name: HM11260C
Experimental: Cohort4
HM11260C 8mcg/kg or Placebo
Drug: HM11260C
HM11260C 8mcg/kg or Placebo
Other Name: HM11260C
Experimental: Cohort5
HM11260C 14mcg/kg or Placebo
Drug: HM11260C
HM11260C 14mcg/kg or Placebo
Other Name: HM11260C

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01093729

Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
Principal Investigator: Hanmi Clinical Korea
  More Information

No publications provided

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01093729     History of Changes
Other Study ID Numbers: HM-EXC-101
Study First Received: March 23, 2010
Last Updated: February 6, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Hanmi Pharmaceutical Company Limited:
Exendin-4

ClinicalTrials.gov processed this record on August 28, 2014