A Study of HM10560A in Healthy Male Subject

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

• 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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: HM10560A

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 54 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: cohort 1; HM10560A 0.089 mg/kg or Placebo	Drug: Placebo; Placebo; Drug: HM10560A; Subcutaneously administrate at 0 hour on Day 1
EXPERIMENTAL: cohort 2; HM10560A 0.179 mg/kg or Placebo	Drug: Placebo; Placebo; Drug: HM10560A; Subcutaneously administrate at 0 hour on Day 1
EXPERIMENTAL: cohort 3; HM10560A 0.357 mg/kg or Placebo	Drug: Placebo; Placebo; Drug: HM10560A; Subcutaneously administrate at 0 hour on Day 1
EXPERIMENTAL: cohort 4; HM10560A 0.714 mg/kg or Placebo	Drug: Placebo; Placebo; Drug: HM10560A; Subcutaneously administrate at 0 hour on Day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Investigate Safety of HM10560A: Physical examination, Laboratory test, ECG, Vital sign, Adverse event, Local tolerability	1, 2, 3, 5, 7, 11, 15, 22, 29 day after administration

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited
• Investigators: Study Director: Jahon Kang, Hanmi pharma.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (ACTUAL): August 1, 2010
• Study Completion (ACTUAL): August 1, 2010

Study Registration Dates

• First Submitted: March 25, 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: February 1, 2014

More Information

Terms related to this study

• Keywords: Healthy
• Other Study ID Numbers: HM-GHA-101