A Study of HM10560A in Healthy Male Subject

NCT01093742 | Completed Phase 1

• 1 other identifier: HM-GHA-101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Healthy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

cohort 1

EXPERIMENTAL

HM10560A 0.089 mg/kg or Placebo

Drug: HM10560A; Drug: Placebo

cohort 2

EXPERIMENTAL

HM10560A 0.179 mg/kg or Placebo

Drug: HM10560A; Drug: Placebo

cohort 3

EXPERIMENTAL

HM10560A 0.357 mg/kg or Placebo

Drug: HM10560A; Drug: Placebo

cohort 4

EXPERIMENTAL

HM10560A 0.714 mg/kg or Placebo

Drug: HM10560A; Drug: Placebo

Interventions

HM10560A DRUG

Subcutaneously administrate at 0 hour on Day 1

cohort 1; cohort 2; cohort 3; cohort 4

Placebo DRUG

Placebo

cohort 1; cohort 2; cohort 3; cohort 4

Eligibility Criteria

• Age: 20 Years - 54 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Body mass index of ≥19 and ≤26 Subject
• Medically healthy with no clinically significant screening results through Physical examination, 12 lead ECG, Laboratory test
• Able to participate in all procedure
• SBP 90-140 mmHg, DBP 60-90 mmHg, Pulse rate 50-90 times/min
• AST, ALT \<1.5 X UNL, CPK \< 2 X UNL
• Able to abstain from alcohol and smoke during study period
• Consented to contraception until 2 month after end of the study

You may not qualify if:

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

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

Medical Center

Seoul, South Korea

Location

Study Officials

• Jahon Kang

  Hanmi pharma.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2010
• First Posted: March 26, 2010
• Study Start: March 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: February 7, 2014

Record last verified: 2014-02

Locations

KR (1)