Clinical trial NCT01093742: A Study of HM10560A in Healthy Male Subject
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2010-03-26
Enrollment: 32
Sex: MALE
Minimum age (years): 20
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety
timeFrame: 1, 2, 3, 5, 7, 11, 15, 22, 29 day after administration
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Medical Center
Study officials:
affiliation: Hanmi pharma.
name: Jahon Kang
role: STUDY_DIRECTOR
References: