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CompletedNCT01093742Updated Feb 7, 2014

A Study of HM10560A in Healthy Male Subject

A Phase 1 interventional study of HM10560A and Placebo in Healthy, sponsored by Hanmi Pharmaceutical Company Limited. Completed at 1 site in Korea, Republic of. Open to male participants aged 20 Years to 54 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-02-07.

Sponsored by Hanmi Pharmaceutical Company Limited · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
20 Years to 54 Years
Sex
Male
01

Study 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.
Read the 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.
02

Conditions studied

  • Healthy

Keywords

  • Healthy
03

In context

Lead sponsor

Hanmi Pharmaceutical Company Limited is the lead sponsor of 188 studies on the registry; 10 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 6 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 54 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    cohort 1

    HM10560A 0.089 mg/kg or Placebo

    Drug: HM10560A · Drug: Placebo

  • Experimental
    cohort 2

    HM10560A 0.179 mg/kg or Placebo

    Drug: HM10560A · Drug: Placebo

  • Experimental
    cohort 3

    HM10560A 0.357 mg/kg or Placebo

    Drug: HM10560A · Drug: Placebo

  • Experimental
    cohort 4

    HM10560A 0.714 mg/kg or Placebo

    Drug: HM10560A · Drug: Placebo

Interventions

  • DrugHM10560A

    Subcutaneously administrate at 0 hour on Day 1

  • DrugPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. Safety

    Investigate Safety of HM10560A: * Physical examination, Laboratory test, ECG, Vital sign, Adverse event, Local tolerability

    Time frame: 1, 2, 3, 5, 7, 11, 15, 22, 29 day after administration

07

Study locations

1 site
  • Medical Center
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01093742
Lead sponsor
Hanmi Pharmaceutical Company Limited
Responsible party
Sponsor
First posted
Mar 26, 2010
Start date
Mar 2010
Primary completion
Aug 2010
Completion
Aug 2010
Last update
Feb 7, 2014

Study contacts

Jahon Kang
study director · Hanmi pharma.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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