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

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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01037543

Enrollment

Registered

2009-12-23

Start date

2009-11-30

Completion date

2011-04-30

Last updated

2014-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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.

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.

Interventions

DRUGHM10460A or placebo or Neulasta

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Safety data, including physical examinations (to include injection site reactions and splenic evaluations), laboratory evaluations, ECGs, vital signs assessments, and adverse effects (AEs).	Time points where appropriate.
Samples for immunogenicity	Days -1, 15, 22, and 42.

Secondary

Measure	Time frame
PK parameters measured from Serum and Urine samples.	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.	pre-dose, 24 and 48 hours post-dose, Days 4, 5, 6, 7, 11, 15, and 22.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026