A Randomized, Double-Blind, Placebo-Controlled, Escalating Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HM10460A (HNK460) When Administered Subcutaneously to Healthy Adult Korean Subjects
A Randomized, Double-Blind, Placebo-Controlled, Escalating Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HM10460A (HNK460) When Administered Subcutaneously to Healthy Adult Korean Subjects
Study Design
Objectives
The secondary objectives of the study are as follows:
Inclusion Criteria:
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:
Females of non-childbearing potential must have undergone one of the following sterilization procedures at least 6 months prior to Day 1:
Exclusion Criteria:
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:
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.