A Study of HM10560A in Healthy Male Subject

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: HM10560A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01093742

HM-GHA-101

Details and patient eligibility

About

• 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.

Full 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.

Enrollment: 32 patients

Sex: Male

Ages: 20 to 54 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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32 participants in 4 patient groups

cohort 1

Experimental group

Description:

HM10560A 0.089 mg/kg or Placebo

Treatment:

Drug: Placebo

Drug: HM10560A

cohort 2

Experimental group

Description:

HM10560A 0.179 mg/kg or Placebo

Treatment:

Drug: Placebo

Drug: HM10560A

cohort 3

Experimental group

Description:

HM10560A 0.357 mg/kg or Placebo

Treatment:

Drug: Placebo

Drug: HM10560A

cohort 4

Experimental group

Description:

HM10560A 0.714 mg/kg or Placebo

Treatment:

Drug: Placebo

Drug: HM10560A