Status:
COMPLETED
Assess the Safety, Tolerability, and Pharmacokinetic (PK) Characteristics of HM10460A (HNK460) in Healthy Adult Korean Subjects
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Healthy
Eligibility:
All Genders
20-45 years
Phase:
PHASE1
Brief Summary
* Study Design * Randomized, Double-blind, Placebo-controlled, escalating single-dose design. * Five ascending dose cohorts. * In each cohort, subjects will be randomized to receive a single do...
Detailed Description
The secondary objectives of the study are as follows: * to assess the pharmacokinetics (PK) of a single subcutaneous dose of HM10460A. * to assess the relationship between the serum concentration of ...
Eligibility Criteria
Inclusion
- Healthy adult Korean male and/or females, 20 - 45 years of age(inclusive).
- BMI of 18 - 27kg/m2.
- Medically healthy with no clinically significant screening results.
- The following results in laboratory test
- Absolute neutrophil count (ANC) : 2000 \~ 7500/mm3
- Non-smokers or subjects who smoke less than 10 cigarettes/day
- After a confirmed menstrual period, females of childbearing potential must be either sexually inactive (abstinent) for 14 days prior to screening and agree to remain so throughout the study, or have been using a highly effective method of birth control, such as the following examples:
- intra-uterine device in place for at least 3 months prior to Day 1;
- stable hormonal contraceptive for at least 3 months prior to Day 1 through completion of study;
- surgical sterilization (vasectomy) of partner at least 6 months prior to Day 1.
- Females of non-childbearing potential must have undergone one of the following sterilization procedures at least 6 months prior to Day 1:
- bilateral tubal ligation;
- hysterectomy;
- hysterectomy with unilateral or bilateral oophorectomy;
- bilateral oophorectomy.
Exclusion
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
- Positive urine drug/alcohol testing at screening or check-in.
- Positive testing for HIV, HBsAg, or HCV antibodies.
- Active infection
- Positive testing for palpable spleen at screening or check-in.
- The following results in laboratory test:
- WBC \> 10.0 x 10\^3/mm3
- Hb \< 13g/dL
- Platelet \< 150 x 10\^3/mm3
- AST/ALT \> 50 IU/L
- History or presence of alcoholism or drug abuse within 2 years prior to Day 1.
- History of G-CSF-related product use (i.e., pegfilgrastim, filgrastim).
- History of anaphylactic reaction to medicine or environmental exposures.
- Use of any prescription medication (with the exception of hormonal contraceptives for females) or receipt of any blood products within 14 days prior to Day 1.
- Use of any over-the-counter medication, including herbal products, within 7 days prior to the Day 1. Up to 2 grams per day of acetaminophen is allowed at the discretion of the Investigator.
- Blood donation or significant blood loss within 56 days prior to Day 1.
- Plasma donation within 7 days prior to Day 1.
- Participation in another clinical trial (receipt of last investigational medication) within 30 days prior to Day 1.
- Females who are pregnant or lactating.
- Subjects who are unlikely to comply with the protocol requirements, instructions and study related restrictions; e.g., uncooperative attitude, inability to return for follow-up visits and improbability of completing the clinical study.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00998283
Start Date
October 1 2009
End Date
September 1 2010
Last Update
February 7 2014
Active Locations (1)
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1
Seoul, South Korea