Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001049561
Ethics application status
Approved
Date submitted
11/09/2015
Date registered
7/10/2015
Date last updated
13/10/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study to evaluate the pharmacokinetic and pharmacodynamic equivalence of HSP-130 and United States-approved Neulasta (Registered Trademark) and European Union-approved Neulasta (Registered Trademark) administered as a single subcutaneous dose to healthy volunteers.
Scientific title
A Phase I study assessing the pharmacodynamic and pharmacokinetic equivalence of HSP-130 with US-approved Neulasta (Registered Trademark) and EU-approved Neulasta (Registered Trademark) administered as a single subcutaneous dose to healthy volunteers.
Secondary ID [1] 287354 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The study will be conducted in healthy subjects. Neulasta is indicated for the treatment of cancer chemotherapy-induced neutropenia. 296016 0
Condition category
Condition code
Cancer 296296 296296 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 292693 0
Treatment: Drugs
Comparator / control treatment
The comparator/ control for this trial are:

Treatment B: US-approved Neulasta (pegfilgrastim, Amgen), 6 mg, single SC injection in the deltoid region.
Treatment C: EU-approved Neulasta (pegfilgrastim, Amgen), 6 mg, single SC injection in the deltoid region.
Control group
Active

Outcomes
Primary outcome [1] 295951 0
The primary outcome is a composite assessment of the pharmacodynamic measures of area under the effect versus time curve for Absolute Neutrophil Count (ANC) from the time of dose administration to the 288 hour sample after dose administration (AUECanc) and the maximum observed value for ANC (ANC_Cmax).
Timepoint [1] 295951 0
Blood assessments will be carried out for PD (ANC) analysis.
Measurements to be taken 14 times in each period which include 1 hour prior to dose administration and at 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 hours post-dose.
Secondary outcome [1] 317010 0
The secondary pharmacodynamic outcome is the time of maximum value for ANC (ANC_Tmax) from the time of dosing to 288 hours.
Timepoint [1] 317010 0
Blood assessments will be carried out for PD analysis. Measurements to be taken 14 times in each period which include 1 hour prior to dose administration and at 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 hours post-dose.
Secondary outcome [2] 317011 0
The secondary outcome is a composite outcome assessing pharmacokinetics which will include area under the serum pegylated filgrastim versus time curve from the time of dose administration to time infinity (AUC0-infinity) and the maximum observed serum pegylated filgrastim concentration (Cmax).
Timepoint [2] 317011 0
Blood assessments will be carried out for PK analysis. Measurements to be taken 21 times in each period which include 1 hour prior to dose and at 1, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 hours post-dose.
Secondary outcome [3] 317012 0
To assess the safety of HSP-130 by recording the adverse events (AEs), laboratory assessments, vital signs, ECG, and physical examination throughout the duration of the study. The known possible adverse events include bone pain and back pain, allergic reactions, splenic rupture, acute respiratory distress syndrome, sickle cell disease, inflammation of blood vessels, higher than normal count for white blood cells and lower than normal count for platelets.
Timepoint [3] 317012 0
Subjects will be assessed for AEs and vital signs for a minimum of 6 days during confinement and 10 days as outpatient visits.
laboratory assessments (blood and urine) will be assessed for a minimum of 3 days during confinement and 3 days during out-patient visits.
ECGs will be assessed twice during the study (both during out-patient visits).
Directed physical examination will be performed to assess the spleen at each visit during confinement and as outpatient, either as directed examination only or as part of a full physical examination which will be performed a total of 3 times during the study.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
18/09/2015
Date of last participant enrolment
Anticipated
Actual
13/11/2015
Date of last data collection
Anticipated
Actual
3/06/2016
Sample size
Target
150
Accrual to date
Final
153
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 291914 0
Commercial sector/Industry
Name [1] 291914 0
Hospira, Inc.
Country [1] 291914 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Hospira, Inc.
Address
275 North Field Drive
Lake Forest, IL 60045
Country
United States of America
Secondary sponsor category [1] 290583 0
None
Name [1] 290583 0
Address [1] 290583 0
Country [1] 290583 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293624 0
Ethics committee address [1] 293624 0
Ethics committee country [1] 293624 0
Date submitted for ethics approval [1] 293624 0
Approval date [1] 293624 0
10/08/2015
Ethics approval number [1] 293624 0

Summary
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59850 0
Dr Sepehr Shakib
Address 59850 0
CMAX, a Division of IDT Australia Ltd. Level 5, 18a North Tce, Adelaide, SA 5000
Country 59850 0
Australia
Phone 59850 0
+61 8 7088 7900
Fax 59850 0
+61 8 70887999
Email 59850 0
[email protected]
Contact person for public queries
Name 59851 0
Dr Faith Ottery
Address 59851 0
275 N. Field Dr.
Dept. 040J Bldg H2-2E
Lake Forest, IL 60045
Country 59851 0
United States of America
Phone 59851 0
+1 224-212-3630
Fax 59851 0
Email 59851 0
[email protected]
Contact person for scientific queries
Name 59852 0
Dr Faith Ottery
Address 59852 0
275 N. Field Dr.
Dept. 040J Bldg H2-2E
Lake Forest, IL 60045
Country 59852 0
United States of America
Phone 59852 0
+1 224-212-3630
Fax 59852 0
Email 59852 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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