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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01093742 |
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Date of registration:
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25/03/2010 |
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Primary sponsor: |
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Public title:
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A Study of HM10560A in Healthy Male Subject
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Scientific title:
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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 |
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Date of first enrolment:
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March 2010 |
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Target sample size:
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32 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01093742 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Kyun-Seop Bae, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Asan Medical Center |
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Key inclusion & exclusion criteria
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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
Age minimum:
20 Years
Age maximum:
54 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Healthy
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Intervention(s)
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Drug: HM10560A
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Drug: Placebo
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Primary Outcome(s)
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Safety
[Time Frame: 1, 2, 3, 5, 7, 11, 15, 22, 29 day after administration]
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Secondary ID(s)
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HM-GHA-101
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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