A Study of HM10560A in Healthy Male Subject

NCT ID: NCT01093742

Last Updated: 2014-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2010-08-31

Brief Summary

• 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.

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

cohort 1

HM10560A 0.089 mg/kg or Placebo

Group Type: EXPERIMENTAL

HM10560A

Intervention Type: DRUG

Subcutaneously administrate at 0 hour on Day 1

Placebo

Intervention Type: DRUG

Placebo

cohort 2

HM10560A 0.179 mg/kg or Placebo

Group Type: EXPERIMENTAL

HM10560A

Intervention Type: DRUG

Subcutaneously administrate at 0 hour on Day 1

Placebo

Intervention Type: DRUG

Placebo

cohort 3

HM10560A 0.357 mg/kg or Placebo

Group Type: EXPERIMENTAL

HM10560A

Intervention Type: DRUG

Subcutaneously administrate at 0 hour on Day 1

Placebo

Intervention Type: DRUG

Placebo

cohort 4

HM10560A 0.714 mg/kg or Placebo

Group Type: EXPERIMENTAL

HM10560A

Intervention Type: DRUG

Subcutaneously administrate at 0 hour on Day 1

Placebo

Intervention Type: DRUG

Placebo

Interventions

HM10560A

Subcutaneously administrate at 0 hour on Day 1

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 54 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jahon Kang

Role: STUDY_DIRECTOR

Hanmi pharma.

Locations

Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

HM-GHA-101

Identifier Type: -

Identifier Source: org_study_id