A Study of HM10560A in Healthy Male Subject

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01093742
First received: March 25, 2010
Last updated: February 6, 2014
Last verified: February 2014
  Purpose
  • Study Design

    • Randomized, Double-blind, Placebo-controlled, escalating single-dose design.
    • Four ascending dose cohorts.
    • In each cohort, subjects will be randomized to receive a single dose of HM10560A or placebo (negative control).
  • Objectives

    • The primary objective of the study is to assess the safety and tolerability of single escalating subcutaneous doses of HM10560A in healthy male subjects.

Condition Intervention Phase
Healthy
Drug: HM10560A
Drug: Placebo
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, Placebo-controlled, Single Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of HM10560A After S.C. Administration in Healthy Male Subjects

Further study details as provided by Hanmi Pharmaceutical Company Limited:

Primary Outcome Measures:
  • Safety [ Time Frame: 1, 2, 3, 5, 7, 11, 15, 22, 29 day after administration ] [ Designated as safety issue: Yes ]

    Investigate Safety of HM10560A:

    • Physical examination, Laboratory test, ECG, Vital sign, Adverse event, Local tolerability


Enrollment: 32
Study Start Date: March 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cohort 1
HM10560A 0.089 mg/kg or Placebo
Drug: HM10560A
Subcutaneously administrate at 0 hour on Day 1
Drug: Placebo
Placebo
Experimental: cohort 2
HM10560A 0.179 mg/kg or Placebo
Drug: HM10560A
Subcutaneously administrate at 0 hour on Day 1
Drug: Placebo
Placebo
Experimental: cohort 3
HM10560A 0.357 mg/kg or Placebo
Drug: HM10560A
Subcutaneously administrate at 0 hour on Day 1
Drug: Placebo
Placebo
Experimental: cohort 4
HM10560A 0.714 mg/kg or Placebo
Drug: HM10560A
Subcutaneously administrate at 0 hour on Day 1
Drug: Placebo
Placebo

Detailed Description:

The secondary objectives of the study are as follows:

  • To assess the pharmacokinetics(PK) and pharmacodynamics(PD) of a single subcutaneous dose of HM10560A.
  Eligibility

Ages Eligible for Study:   20 Years to 54 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male volunteers, age range 20 to 54 years are informed of the investigational nature of this study and voluntarily agrees to participate in this study
  2. Body mass index of ≥19 and ≤26 Subject
  3. Medically healthy with no clinically significant screening results through Physical examination, 12 lead ECG, Laboratory test
  4. Able to participate in all procedure
  5. SBP 90-140 mmHg, DBP 60-90 mmHg, Pulse rate 50-90 times/min
  6. AST, ALT <1.5 X UNL, CPK < 2 X UNL
  7. Able to abstain from alcohol and smoke during study period
  8. Consented to contraception until 2 month after end of the study

Exclusion Criteria:

  1. Acute infection history within 14 days
  2. Prior exposure or hypersensitivity to recombinant human growth hormone
  3. Positive findings on HBsAg, Anti-HAV IgM, anti-HCV, HIV Ag, HIV Ab and syphilis high quality regain test
  4. History of significant gastrointestinal, cardiac, pulmonary, hepato- and nephro- disease
  5. psychiatric disorder, malignancy tumor, hormonal disorder, diabetes mellitus and hypertension or history of immunosuppressant treatment
  6. Caffeine, alcohol and smoke abuse
  7. History of hemophilia or anticoagulant treatment
  8. Revulsion and/or panic about syringe needle and hypersensitivity to subcutaneously administration
  9. History drug abuse or positive testing for amphetamine, barbiturate, cocaine, opiates, benzodiazepines
  10. Blood donation or significant blood loss within 60 days prior to Day 1. Plasma donation or transfusion within 30 days prior to Day 1.
  11. Receipt of another investigational medication within 60 days prior to Day 1
  12. Use of any herbal products within 30 days or prescription medication within 14 days or over-the-counter medication within 7 days prior to the Day 1.
  13. Subjects who are unlikely to comply with the protocol requirements, instructions and study related restrictions
  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: NCT01093742

Locations
Korea, Republic of
Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
Study Director: Jahon Kang Hanmi pharma.
  More Information

No publications provided

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01093742     History of Changes
Other Study ID Numbers: HM-GHA-101
Study First Received: March 25, 2010
Last Updated: February 6, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Hanmi Pharmaceutical Company Limited:
Healthy

ClinicalTrials.gov processed this record on July 24, 2014