A Study to compare BioSimilar Sciences Filgrastim (BSC-1020) to Neupogen® Following Subcutaneous Administration to Healthy Subjects
- Registration Number
- CTRI/2021/05/033311
- Lead Sponsor
- BioSimilar Sciences LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
2. Healthy, adult, male or female, 18-55 years of age, inclusive, at the time of ICF signing.
3. Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing and throughout the study, based on subject self-reporting.
4. Body mass index (BMI) >= 18 and <= 30.0 kg/m2 and with body weight between 50 kg and 100 kg, at screening.
5. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee.
6. A female of childbearing potential is either sexually inactive (abstinent as a lifestyle) for 28 days prior to the first dosing and throughout the study or using one of the following acceptable birth control methods:
6.1 hormonal oral contraceptives, vaginal ring, transdermal patch, hormone or non-hormone releasing intrauterine device for at least 3 months prior to the first dosing and throughout the study.
6.2 depot/implantable hormone (e.g., Depo-provera®, Implanon) for at least 3 months prior to the first dosing and throughout the study.
6.3 surgical sterilization of the partner (vasectomy for 4 months minimum prior to the first dosing.
6.4 physical barrier method (e.g., condom, diaphragm) with spermicide for at least 14 days prior to the first dosing and throughout the study.
A female subject who claims to be sexually inactive but becomes sexually active during the course of the study must agree to use a physical barrier method (e.g., condom, diaphragm) with spermicide from the time of the start of sexual activity and throughout the study.
In addition, female subjects of childbearing potential will be advised to remain sexually inactive or to keep the same birth control method for at least 28 days after the last dose.
7. A female of non-childbearing potential has undergone one of the following sterilization procedures at least 6 months prior to the first dosing:
7.1 hysteroscopic sterilization;
7.2 bilateral tubal ligation or bilateral salpingectomy;
7.3 hysterectomy;
7.4 bilateral oophorectomy
or be postmenopausal with amenorrhea for at least 1 year prior to the first dosing and follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status.
8. A non-vasectomized, male subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days after the last dosing. (No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to the first dosing. A male who has been vasectomized less than 4 months prior to study first dosing must follow the same restrictions as a non-vasectomized male).
9. If male, must agree not to donate sperm from the first dosing until 90 days after the last dosing.
10. Agrees to abstain from alcohol consumption throughout duration of the study and has a negative alcohol urine test at screening and first check-in.
1. Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
2. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
3. History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
4. History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing.
5. Any active systemic or immunologic disease or condition, including but not limited to the following general categories: cardiovascular/pulmonary, hepatorenal, or systemic infection, or lactation.
6. Hematologic laboratory abnormalities including leukocytosis (defined as total leukocytes > 11,000/μL), leukopenia (defined as total leukocytes < 4000/μL), or neutropenia (defined as absolute neutrophil count [ANC] < 1500/μL) or thrombocytopenia (defined as platelet count of < 150/μL).
7. History of biological growth factor exposure, including but not limited to filgrastim and other G-CSFs in the context of treatment, prophylaxis, peripheral blood stem cell mobilization, or previous investigational study setting.
8. Drug sensitivity, allergic reaction to, or known hypersensitivity/idiosyncratic reaction to E. coli-derived proteins, filgrastim, pegfilgrastim, other granulocyte colony-stimulating factors or any component of the product: Subjects with the rare heredity problem of fructose intolerance are excluded due to the excipient sorbitol.
9. History of splenic rupture (or subject who is asplenic), pulmonary infiltrate or pneumonia, sickle cell disorders, chronic neutropenia, thrombocytopenia, or vasculitis.
10. History or presence of:
10.1 febrile or infectious illness within 1 week of first dose.
10.2 clinically significant skin disorders, including psoriasis.
11. History of pulmonary infiltrate or pneumonia within 6 months of first dose. Chest X-ray will be performed at screening.
12. History of cancer with the exception of basal/squamous skin cell cancer.
13. Acute infection within one month of first dose, deemed clinically significant in the opinion of the Investigator or designee.
14.No vaccination (including influenza) within 30 days of first dose administration of study drug. COVID-19 vaccination is allowed during the study however, the subject will not receive next dose until 4 weeks past vaccination.
15. Female subjects with a positive pregnancy test at screening or first check-in or lactating.
16. Positive urine alcohol or urine drug of abuse (including amphetamines, barbiturates, benzodiazepines, cocaine, morphine, and marijuana) at screening or first check-in.
17. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
18. Seated blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at screening.
19. Seated heart rate is lower than 40 bpm or higher than 99 bpm at screening.
20. QTcF interval is >460 msec (males) or >470 msec (females) or has ECG findings deemed abnormal with clinical significance by the PI or designee at screening.
21. Unable to refrain from or anticipates the use of:
21.1 Any drug, i
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - PK: To compare the primary PK parameters of BSC-1020, US Neupogen, and EU Neupogen, after single SC administration in healthy adult subjects. <br/ ><br>- PD: To compare the primary PD parameters (ANC) of BSC-1020, US Neupogen, and EU Neupogen, after single SC administration in healthy adult subjects. <br/ ><br>Timepoint: - The primary PK endpoints will be the 90% CIs of the ratios of the least-squares means (LSM) of the ln-transformed PK parameters AUC0â??inf and Cmax of filgrastim in serum for BSC-1020, US Neupogen, and EU Neupogen. <br/ ><br>- - The primary PD endpoints will be the 90% CIs of the ratios of the LSM of the appropriate-transformed PD parameters AUEC0-t and Emax on Days 1 through 6 for ANC for BSC-1020, US Neupogen, and EU Neupogen. <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method