Assess the Safety, Tolerability, and Pharmacokinetic (PK) Characteristics of HM10460A (HNK460) in Healthy Adult Korean Subjects

NCT00998283 | Completed Phase 1 DMC

• 1 other identifier: 09-HM10460A-102
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Safety data, including physical examinations (to include injection site reactions and splenic evaluations), laboratory evaluations, ECGs, vital signs, and adverse effects (AEs)

  Time point of collection, where appropriate

• Samples for immunogenicity

  Time point of collection, where appropriate

Secondary Outcomes (2)

• Serum PK parameters/Urine PK parameters

  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.

  Pre-dose, 24 and 48 hours post-dose, on return Days 4,5,6,7,11,15 and 22

Study Arms (5)

Cohort 1

EXPERIMENTAL

Administration of HM10460A 5μg/kg or Placebo

Drug: HM10460A 5μg/kg; Drug: Placebo

Cohort 2

EXPERIMENTAL

Administration of HM10460A 15μg/kg or placebo

Drug: HM10460A 15μg/kg; Drug: Placebo

Cohort 3

EXPERIMENTAL

Administration of HM10460A 45μg/kg or placebo

Drug: HM10460A 45μg/kg; Drug: Placebo

Cohort 4

EXPERIMENTAL

Administration of HM10460A 135μg/kg or placebo

Drug: HM10460A 135μg/kg; Drug: Placebo

Cohort 5

EXPERIMENTAL

Administration of HM10460A 350μg/kg or placebo

Drug: HM10460A 350μg/kg; Drug: Placebo

Interventions

HM10460A 5μg/kg DRUG

Subcutaneously administrate at 0 hour on Day 1

Cohort 1

HM10460A 15μg/kg DRUG

Subcutaneously administrate at 0 hour on Day 1

Cohort 2

HM10460A 45μg/kg DRUG

Subcutaneously administrate at 0 hour on Day 1

Cohort 3

HM10460A 135μg/kg DRUG

Subcutaneously administrate at 0 hour on Day 1

Cohort 4

HM10460A 350μg/kg DRUG

Subcutaneously administrate at 0 hour on Day 1

Cohort 5

Placebo DRUG

Subcutaneously administrate at 0 hour on Day 1

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

Unknown Facility

Seoul, South Korea

Location

MeSH Terms

Interventions

eflapegrastim

Study Officials

• Hanmi Clinical

  Seoul

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2009
• First Posted: October 20, 2009
• Study Start: October 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: February 7, 2014

Record last verified: 2014-02

Locations

KR (1)