StudyEvaluating the(PK),(PD), Safety,andImmunogenicity between BSC-0826 and US-licensed Neulasta and EU-approvedNeulasta Part 1, and Evaluating the Safety and Immunogenicity in Part 2 of BSC-0826 to EU-Neulasta�®following Subcutaneous Administration to Healthy Subjects
- Registration Number
- CTRI/2021/10/037600
- Lead Sponsor
- Veeda Clinical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- 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 45 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:
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.
â�¢ depot/implantable hormone (e.g., Depo-provera�®, Implanon) for at least 3 months prior
to the first dosing and throughout the study.
� surgical sterilization of the partner (vasectomy for 4 months minimum prior to the first
dosing.
� 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:
� hysteroscopic sterilization;
� bilateral tubal ligation or bilateral salpingectomy;
� hysterectomy;
� 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 breath 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/�¼L), leukopenia (defined as total leukocytes < 4000/�¼L), or neutropenia (defined
as ANC < 1500/�¼L) or thrombocytopenia (defined as platelet count of < 150/�¼L).
7. History of biological growth factor exposure, including but not limited to filgrastim,
pegfilgrastim, 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 G-CSFs, 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:
� febrile or infectious illness within 1 week of first dose.
� 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 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 results (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. Positive COVID-19 result at screening by RT-PCR testing.
19. Seated blood pressure is less than 90/60 mmHg or greater than 140/90 mmHg at screening.
20. Seated heart rate is lower than 50 bpm or higher than 85 bpm at screening.
21. QTcF interval is >460 msec (males)
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method