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.

A Randomized, Single-Dose, Double-Blind, Two-Sequence, Two-Period Crossover Study to compare Pharmacokinetics, Pharmacodynamics, Immunogenicity and Safety of BP14 (Pegfilgrastim) with EU-approved Neulasta® in Healthy Male Adult Subjects.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12620000657921

Enrollment

124

Registered

2020-06-09

Start date

2020-07-22

Completion date

2021-02-08

Last updated

2021-08-24

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

Conditions

None listed

Brief summary

The purpose of this study is to compare the pharmacokinetics (what the body does to a drug), pharmacodynamics (effect of drugs on the body), immunogenicity (ability to provoke an immune response) and safety of BP14 with Neulasta in healthy males. Who is it for? You may be eligible to join this study if you are a healthy male aged 18 to 55 years. Study details All participants in this study will undergo two separate treatments in random order separated by a period of 42 days. One treatment involves administration of the ‘test product’, a drug called BP14 (pegfilgrastim). A single 6mg dose will be administered by injection under the skin (subcutaneous). The other treatment is a 6 mg injection of the European Union-approved drug, Neulasta. This drug is recommended for use in cancer patients undergoing chemotherapy, to reduce the incidence of infection. All participants will undergo regular blood tests and safety assessments throughout the study, in order to evaluate how the body responds to the drug. We hope that BP14 (pegfilgrastim) will be comparable to Neulasta, warranting further investigational trials to evaluate its efficacy in cancer patients.

Interventions

Test Product Treatment A: Single subcutaneous (SC) dose of BP14 (pegfilgrastim) (Manufactured by CURATEQ BIOLOGICS PRIVATE LIMITED PLOT NO.2, MAITRIVIHAR, AMEERPET, HYDERABAD, Telangana, India, 500038 Reference Product Treatment B: Single subcutaneous (SC) dose of Neulasta®. (Manufactured by Amgen Technology (Ireland) Unlimited Company) The treatments will be BP14 (Treatment A) and Neulasta® (Treatment B) the total dose will be a single 6mg subcutaneous injection per treatment over 2 separate treatment periods. It will be conducted as a cross over study design, which means that participants will receive a sequence of two different treatments. Each treatment will be administered in a separate inpatient period separated by a washout period which is at least 42 days between two treatment periods. When participants are dosed at the site, they will receive investigational product (IP) directly from the Investigator or designee, under medical supervision. The date and time of each dose administered in the clinic will be recorded in the source documents and recorded in the eCRF. The dose of IP and study participant identification will be confirmed at the time of dosing by a member of the study site staff other than the person administering the study intervention.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

Male

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

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.

Exclusion criteria

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.

Outcome results