A phase I biosimilar study to compare the pharmacokinetics, Pharmacodynamics, safety and tolerability of BP14 (Pegfilgrastim) with EU-approved Neulasta® in healthy male adult volunteers following a subcutaneous (SC- under the skin) injection.
- Conditions
- Chemotherapy-induced-neutropeniaCancer - Any cancerBlood - Haematological diseases
- Registration Number
- ACTRN12620000657921
- Lead Sponsor
- CURATEQ BIOLOGICS PRIVATE LIMITED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 124
1. Subject is 18 to 55 years of age inclusive, at the time of signing the informed consent.
2. Subject is healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (12-lead electrocardiogram [ECG]).
3. Subject has body mass index (BMI) within the range 18 – 32 kg/m2 (inclusive).
4. Subject is male.
5. The subject must agree to use a highly effective contraception during the study and for at least 90 days after the last dose of IMP and refrain from donating sperm during this period.
6. Subject is capable of and willing to give signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
7. Non-smokers or casual smokers who smoke no more than 5 cigarettes (or equivalent quantity of any other nicotine containing substance) per week. Subject must abstain from smoking 48 hours prior to admission and throughout both the treatment periods.
8. Subject should have a negative breathalyzer result at screening, Day -1, and Day 62.
9. Screening laboratory results (hematology, biochemistry, coagulation, iron profile, and urinalysis) should be within normal limits, or any abnormalities should not be clinically significant, as determined by the Investigator. Repeat laboratory tests are permitted at Investigator’s discretion.
10. Must be general good health as determined by the Investigator based on comprehensive medical history, physical examination findings, vital sign measurements, and clinical laboratory tests (including iron status transferrin saturation greater than or equal to 15%), unless considered not clinically significant by the PI.
At the screening visit, supine vital signs must be within the following ranges:
•Systolic blood pressure between 90 and 139 mmHg,
•Diastolic blood pressure between 60 and 89 mmHg,
•Pulse between 50 and 90 beats per minute (bpm),
•Oral body temperature between 35.0 and 37.5°C.
Normal hematological function at screening as follows:
•ANC 1.5 to 7.0 x 109/L,
•Red blood cells 4.7 to 6.1 million cells per microliter (mcL),
•Platelet count 150 to 400 x 109/L,
•Hemoglobin 14 to 17 g/dL.
11. To rule out symptoms of glandular fever, subjects must test negative for antibodies to the Epstien-Barr virus at screening.
12. Must have normal organ function as per the Investigator judgment.
13. Must have normal liver function as determined by serum bilirubin, alkaline phosphatase (ALP), and transaminases (alanine aminotransaminase [ALT] and aspartate. aminotransaminase [AST]) the upper limit of normal (ULN) unless deemed not clinically significant by the Investigator.
14. Must have adequate renal function defined as serum creatinine less than or equal 1.5 x ULN.
1. Current or previous cancer, diabetes, or any clinically significant cardiovascular, metabolic, renal, hepatic, gastrointestinal, hematologic, respiratory, dermatological, neurological, psychiatric, or any other disorder clinically relevant as judged by the Investigator.
2. History of chronic cough, fever or acute respiratory illness within 4 weeks prior to the day of IMP administration.
3. Known or suspected allergic reaction to latex.
4. Any past or concurrent medical conditions that potentially increase the subject's risks or affect the evaluation of any study results. The Investigator shall take a final call on any medical condition that can interfere in the study results or potentially increase the subject’s risk.
5. Hypersensitivity to the constituents of Neulasta®, pegfilgrastim (sorbitol E420, polysorbate 20 and acetate or acetic acid) or hypersensitivity to E. coli derived proteins.
6. Any history of major surgery that in the opinion of the Investigator would interfere with the study or place the subject at risk.
7. Hereditary fructose and/or sorbitol intolerance.
8. Any history of previous exposure to pegfilgrastim or filgrastim or known allergy to PEG or any similar analogue.
9. Treatment with non-topical medications within 5 days prior to first admission to the study center, with the exception of over the counter medications (such as paracetamol, acetaminophen, vitamins, minerals, or health supplements) which in the Investigator’s judgment do not interfere with IMP administration or the subject’s ability to participate in the study.
10. Participation in a drug study involving hematopoetic growth factors, monoclonal antibodies, or immunoglobulins in the last 6 months prior to first administration of IMP or currently is on a follow-up visit for any other drug studies.
11. Unable to follow protocol instructions in the opinion of the Investigator.
12. Donation or loss of more than 500 mL of blood over a period of 90 days prior to first IMP administration.
13. Positive drug screen for alcohol and drugs of abuse (opiates, methadone, methamphetamines, phencyclidine, tetrahydrocannabinol, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, cotinine and alcohol) at screening and admission (Day-1), unless a positive result is attributable to a documented use of a concomitant medication and is approved by the Investigator. (In case of positive urine drug screen at screening or on Day -1 of Period 1. At the Investigator’s discretion, the drug screen test may be repeated in the possible instance of a false positive due to i.e., poppy seed consumption.)
14. History of alcohol abuse or excessive intake of alcohol in the past 2 years as judged by the Investigator.
15. Positive screen on hepatitis B surface antigen (HBsAg), hepatitis B core antibody, anti hepatitis C virus (HCV) antibodies, or anti-human immunodeficiency virus (HIV) 1/2 antibodies at screening.
16. Family history of acute myeloid leukemia or subjects with splenomegaly (spleen size greater than 13 cm in the craniocaudal dimension by ultrasound) at baseline, or with sickle cell disease.
17.Involvement of any Aurobindo Pharma Ltd., CuraTeQ Biologics GmbH, Contract Research Organization (CRO) or study center employee or their close relatives.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method