Safety and PK of HM10460A (HNK460) in Healthy Adult Japanese and Caucasian Subjects - Full Text View

Purpose

Study Design

Randomized, double-blind, placebo-controlled, escalating single-dose design.
Six ascending dose cohorts
In each cohorts, subjects will be randomized to receive a single dose of HM10460A, placebo (negative control), or Neulasta® (positive control).
Primary Objective
to assess the safety and tolerability of single escalating subcutaneous doses of HM10460A in healthy adult Japanese and Caucasian subjects.

Condition	Intervention	Phase
Healthy	Drug: HM10460A or placebo or Neulasta	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Placebo- and Active-Controlled, Escalating Single-Dose Study to Evaluate the Safety, Tolerability, and PK of HM10460A (HNK460) When Administered Subcutaneously to Healthy Adult Japanese and Caucasian Subjects.

Resource links provided by NLM:

Drug Information available for: Pegfilgrastim

U.S. FDA Resources

Further study details as provided by Hanmi Pharmaceutical Company Limited:

Primary Outcome Measures:

Safety data, including physical examinations (to include injection site reactions and splenic evaluations), laboratory evaluations, ECGs, vital signs assessments, and adverse effects (AEs). [ Time Frame: Time points where appropriate. ] [ Designated as safety issue: Yes ]
Samples for immunogenicity [ Time Frame: Days -1, 15, 22, and 42. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

PK parameters measured from Serum and Urine samples. [ Time Frame: Serum samples: pre-dose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hrs, Days 4, 5, 6, 7, 11, 15, and 22. / Urine Samples: 0 - 6, 6 - 12, 12 - 24, 24 - 36, and 36 - 48 hours post-dose. ] [ Designated as safety issue: No ]
Calculation of ANC and CD34+ cell counts. [ Time Frame: pre-dose, 24 and 48 hours post-dose, Days 4, 5, 6, 7, 11, 15, and 22. ] [ Designated as safety issue: No ]

Estimated Enrollment:	84
Study Start Date:	November 2009
Study Completion Date:	April 2011
Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Cohort 1 1.1 mcg/kg of HM10460A, placebo, or Neulasta	Drug: HM10460A or placebo or Neulasta Single SC injection of the appropriate dose of drug ranging from 1.1 mcg/kg to 270 mcg/kg. Other Name: LAPS-G-CSF
Experimental: Cohort 2 3.3 mcg/kg HM10460A, placebo or Neulasta	Drug: HM10460A or placebo or Neulasta Single SC injection of the appropriate dose of drug ranging from 1.1 mcg/kg to 270 mcg/kg. Other Name: LAPS-G-CSF
Experimental: Cohort 3 10 mcg/kg of HM10460A, placebo, or Neulasta	Drug: HM10460A or placebo or Neulasta Single SC injection of the appropriate dose of drug ranging from 1.1 mcg/kg to 270 mcg/kg. Other Name: LAPS-G-CSF
Experimental: Cohort 4 30 mcg/kg of HM10460A, placebo, or Neulasta	Drug: HM10460A or placebo or Neulasta Single SC injection of the appropriate dose of drug ranging from 1.1 mcg/kg to 270 mcg/kg. Other Name: LAPS-G-CSF
Experimental: Cohort 5 90 mcg/kg or HM10460A, placebo, or Neulasta	Drug: HM10460A or placebo or Neulasta Single SC injection of the appropriate dose of drug ranging from 1.1 mcg/kg to 270 mcg/kg. Other Name: LAPS-G-CSF
Experimental: Cohort 6 270 mcg/kg of HM10460A, placebo, or Neulasta	Drug: HM10460A or placebo or Neulasta Single SC injection of the appropriate dose of drug ranging from 1.1 mcg/kg to 270 mcg/kg. Other Name: LAPS-G-CSF

Detailed Description:

Secondary objectives:

to assess the pharmacokinetics (PK) of a single subcutaneous dose of HM10460A.
to compare the PK of HM10460A in Japanese and Caucasian subjects.
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 potential of HM10460A by measuring binding antibodies (bAb) and neutralizing antibodies (nAb) to HM10460A and native G-CSF following a single subcutaneous dose of HM10460A.

Eligibility

Criteria

Inclusion Criteria:

BMI of 18 - 29.9 kg/m2
have not used tobacco or nicotine containing products for at least 3 months prior to dosing
be able to remain abstinent throughout the study.

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
Positive for HIV, HBsAg, HCV ab
History of anaphylactic reaction to medicine or environmental exposure

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01037543

Locations

United States, California
California Clinical Trials
Glendale, California, United States

Sponsors and Collaborators

Hanmi Pharmaceutical Company Limited

Parexel

Investigators

Principal Investigator:

Mark Yen, MD

California Clinical Trials Medical Group

More Information

No publications provided

Responsible Party:	Kyungmi Park / Director, Hanmi Pharmaceutical Company., Limited.
ClinicalTrials.gov Identifier:	NCT01037543 History of Changes
Other Study ID Numbers:	08-HM10460A-101
Study First Received:	December 21, 2009
Last Updated:	April 26, 2011
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 21, 2013