Clinical trial NCT01037543: Safety and PK of HM10460A (HNK460) in Healthy Adult Japanese and Caucasian Subjects
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2009-12-23
Enrollment: 84
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Safety data, including physical examinations (to include injection site reactions and splenic evaluations), laboratory evaluations, ECGs, vital signs assessments, and adverse effects (AEs).
timeFrame: Time points where appropriate.
measure: Samples for immunogenicity
timeFrame: Days -1, 15, 22, and 42.
Secondary outcomes:
measure: PK parameters measured from Serum and Urine samples.
timeFrame: 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.
measure: Calculation of ANC and CD34+ cell counts.
timeFrame: pre-dose, 24 and 48 hours post-dose, Days 4, 5, 6, 7, 11, 15, and 22.
Other outcomes:
Locations:
city: California
country: United States
state: California
Study officials:
affiliation: California
name: Hanmi Clinical
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jeon Y, Lee N, Baek S, Choi J, Jhee S, Lee H. A Randomized, Double-Blind, Placebo- and Active-Controlled, Escalating Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Profiles of Subcutaneous Eflapegrastim in Healthy Japanese and Caucasian Subjects. Drugs R D. 2022 Mar;22(1):71-87. doi: 10.1007/s40268-021-00379-8. Epub 2022 Jan 6.