- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00998283
Assess the Safety, Tolerability, and Pharmacokinetic (PK) Characteristics of HM10460A (HNK460) in 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
- Randomized, Double-blind, Placebo-controlled, escalating single-dose design.
- Five ascending dose cohorts.
- In each cohort, subjects will be randomized to receive a single dose of HM10460A or placebo (negative control)
Objectives
- The primary objective of the study is to assess the safety and tolerability of single escalating subcutaneous doses of HM10460A in healthy adult Korean Subjects
Study Overview
Status
Conditions
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 HM10460A and absolute neutrophil count (ANC).
- to assess the relationship between the serum concentration of HM10460A and CD34+ cell counts in the blood.
- to assess the immunogenicity (HM10460A, native G-CSF antibody,neutralizing antibodies) of a single subcutaneous dose of HM10460A.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- 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 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:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Cohort 1
Administration of HM10460A 5μg/kg or Placebo
|
Subcutaneously administrate at 0 hour on Day 1
Subcutaneously administrate at 0 hour on Day 1
|
EXPERIMENTAL: Cohort 2
Administration of HM10460A 15μg/kg or placebo
|
Subcutaneously administrate at 0 hour on Day 1
Subcutaneously administrate at 0 hour on Day 1
|
EXPERIMENTAL: Cohort 3
Administration of HM10460A 45μg/kg or placebo
|
Subcutaneously administrate at 0 hour on Day 1
Subcutaneously administrate at 0 hour on Day 1
|
EXPERIMENTAL: Cohort 4
Administration of HM10460A 135μg/kg or placebo
|
Subcutaneously administrate at 0 hour on Day 1
Subcutaneously administrate at 0 hour on Day 1
|
EXPERIMENTAL: Cohort 5
Administration of HM10460A 350μg/kg or placebo
|
Subcutaneously administrate at 0 hour on Day 1
Subcutaneously administrate at 0 hour on Day 1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety data, including physical examinations (to include injection site reactions and splenic evaluations), laboratory evaluations, ECGs, vital signs, and adverse effects (AEs)
Time Frame: Time point of collection, where appropriate
|
Time point of collection, where appropriate
|
Samples for immunogenicity
Time Frame: Time point of collection, where appropriate
|
Time point of collection, where appropriate
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum PK parameters/Urine PK parameters
Time Frame: Serum : pre-dose, 0.25, 05, 0.75, 1,2,3,4,6,8,12,16,24,36,48,72,96,120,144 (hr)// Urine : 0-6, 6-12, 12-24, 24-36, 36,48(hr)
|
Serum : pre-dose, 0.25, 05, 0.75, 1,2,3,4,6,8,12,16,24,36,48,72,96,120,144 (hr)// Urine : 0-6, 6-12, 12-24, 24-36, 36,48(hr)
|
Calculation of the ANC (Absolute Neutrophil count) & CD34+ cell.
Time Frame: Pre-dose, 24 and 48 hours post-dose, on return Days 4,5,6,7,11,15 and 22
|
Pre-dose, 24 and 48 hours post-dose, on return Days 4,5,6,7,11,15 and 22
|
Collaborators and Investigators
Investigators
- Principal Investigator: Hanmi Clinical, Seoul
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-HM10460A-102
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on HM10460A 5μg/kg
-
Atridia Pty Ltd.Linear Clinical ResearchCompleted
-
Hanmi Pharmaceutical Company LimitedCompletedHealthyUnited States
-
Chengdu CoenBiotech Co., LtdJiangsu Province Centers for Disease Control and Prevention; Changde First... and other collaboratorsRecruiting
-
NovavaxActive, not recruiting
-
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Air Force Military Medical University, China; Jiangsu Province Centers for... and other collaboratorsCompleted
-
University of OxfordRecruitingMalaria,FalciparumBurkina Faso
-
Green Cross CorporationCompletedMucopolysaccharidosis IIKorea, Republic of
-
Genor Biopharma Co., Ltd.Unknown
-
Hangzhou Grand Biologic Pharmaceutical, Inc.Peking Union Medical College HospitalUnknownHealthy ParticipantsChina
-
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Shanghai Public Health Clinical Center; Air Force Military Medical University... and other collaboratorsCompleted