None listed
Conditions
Brief summary
The purpose of this study is to assess the PD and PK of Hospira’s pegylated filgrastim, HSP-130 and two pegfilgrastim preparations: US-approved Neulasta and EU-approved Neulasta. You may be eligible to join this study if you are aged between 18 and 65 years, are a non-smoker and have a BMI between 19 and 30 kg/m2, inclusive, and body weight of not less than 50 kg or more than 100 kg. Participants in this study will all receive a single dose of three drugs in a random order (by chance). Each dose will be injected at 6 mg into the shoulder region. This study is designed to demonstrate three things: - that HSP-130 has similar levels in the blood as the same dose of one or both of the approved pegfilgrastims. - that HSP-130 has the same effect on increasing the specific kinds of white blood cells in study subjects as one or both of the approved pegfilgrastims - that HSP-130 has a similar safety profile as both of the approved pegfilgrastims
Interventions
Subject eligibility will be determined during a 28 day Screening Period. A total of 150 subjects will be randomized to 6 sequences, such that 25 subjects will be randomized to each of the sequences. Eligible subjects will be randomly assigned to 1 of 6 sequence groups. Each sequence will receive all 3 treatments as described below:
Treatment A: HSP-130, 6 mg, single subcutaneous injection in the deltoid region
Treatment B: US-approved Neulasta (pegfilgrastim, Amgen), 6 mg, single subcutaneous in
Subject eligibility will be determined during a 28 day Screening Period. A total of 150 subjects will be randomized to 6 sequences, such that 25 subjects will be randomized to each of the sequences. Eligible subjects will be randomly assigned to 1 of 6 sequence groups. Each sequence will receive all 3 treatments as described below: Treatment A: HSP-130, 6 mg, single subcutaneous injection in the deltoid region Treatment B: US-approved Neulasta (pegfilgrastim, Amgen), 6 mg, single subcutaneous injection in the deltoid region Treatment C: EU-approved Neulasta, (pegfilgrastim, Amgen) 6 mg, single subcutaneous injection in the deltoid region There will be at least 56 days of washout between each treatment. Two people will be performing dosing with one carrying out the activity while another observing the same. In addition IP accountability will be done by monitors i.e. reviewing the dispensing records, reviewing the drug labels that will be removed at dose administration and pasted in the subjects source document and reviewing syringe boxes. All the three pegfilgrastim preparations i.e. the pegfilgrastim, US and EU Neulasta have the same amino acid sequences.
Sponsors
Hospira, Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
- BMI between 19 and 30 kg/m2, inclusive, and BW of not < 50 kg or > 100 kg - Non-smoker (defined as a subject who has not smoked and has not used nicotine containing products for at least 3 months prior to study drug administration and has a negative urine screen for cotinine) at Screening - Female subjects of childbearing potential and male subjects and their partners of childbearing potential, agree to pregnancy prevention throughout the duration of the study (through the Follow-up Visit). Subjects and their partners must agree to use an effective method of contraception, to avoid impregnation of females throughout the course of the study.
Exclusion criteria
- Hematologic laboratory abnormalities including leukocytosis, leukopenia, neutropenia or thrombocytopenia. - History of splenic rupture (or subject who is asplenic), pulmonary infiltrate or pneumonia, sickle cell disease, chronic neutropenia, thrombocytopenia, or vasculitis. - Clinically significant as judged by the investigator, vital sign or 12-lead ECG abnormality. - Any clinically significant, as determined by the investigator, abnormal laboratory evaluations, including HIVAb, HBsAg, HCV Ab, and liver function including ALT and AST > 1.5 the ULN taken at screening. - Use of any prescription medicine (exception contraceptives) within 7 days or at least 5 half-lives, whichever is longer. Use of oral or parenteral anticoagulant or antiplatelet agents and corticosteroids should be specifically queried.
Outcome results
None listed