Safety and PK of HM10460A (HNK460) in Healthy Adult Japanese and Caucasian Subjects

Hanmi Pharmaceutical Company Limited84 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Healthy

Interventions

HM10460A or placebo or NeulastaDRUG

Single SC injection of the appropriate dose of drug ranging from 1.1 mcg/kg to 270 mcg/kg.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

California City, California, United States

Outcomes

Primary Outcomes

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.

Samples for immunogenicity

Time frame: Days -1, 15, 22, and 42.

Secondary Outcomes

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.

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.

Data from ClinicalTrials.gov

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