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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01093742

Enrollment

Registered

2010-03-26

Start date

2010-03-31

Completion date

2010-08-31

Last updated

2014-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy

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.

Interventions

DRUGHM10560A

Subcutaneously administrate at 0 hour on Day 1

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to 54 Years

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

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

Design outcomes

Primary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026