| Eligibility |
Inclusion Criteria:
- Healthy subjects,aged =18 but =65,male and female.
- Body mass index:18.0~32.0kg/m²,inclusive.
- Subjects(including their partners) agree to take highly effective contraceptive
measures during the study,and they have no birth plan or sperm donation plan within
3months after the end of the study.
- Female and/or male subjects those meet the below criteria:
If a female subject of child bearing potential-agrees to use one of the accepted
contraceptive regimens from at least 30 days prior to the administration of IMP,during the
study,and for at least 3 months after the end of the study. An acceptable method of
contraception includes one of the following:
Abstinence from heterosexual intercourse Hormonal contraceptives(brith control
pills,injectable/implant/insertable hormonal birth control products, transdermal patch)
Intrauterine device(with or without hormones) OR agrees to use a double barrier method
(e.g. condom and spermicide) . If a female subject of non-childbearing potential - should
be surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or
tubal ligation/occlusion) or in a menopausal state (at least 1 year without menses), as
confirmed by Follicle-stimulating hormone (FSH) levels (= 40 mIU/mL).
A male subject that engages in sexual activity that has the risk of pregnancy must agree to
use a double barrier method (e.g. condom and spermicide) and agree to not donate sperm
during the study and for at least 3 months after the end of the study.
- Medical histories, physical examinations, laboratory examinations and study-related
examinations and tests of the subjects show normal results or mild abnormalities with
no clinical significance before enrollment, and the Investigator judges that they are
eligible.
- Subjects are aware of the risks of the study, and voluntarily participate in the
clinical study and sign an informed consent form (ICF).
Exclusion Criteria:
- History of cardiovascular, respiratory, kidney, liver, metabolism, endocrine,
gastrointestinal, blood, nerve, skin and mental illness, cancer or other major disease
that in the judgment of the Investigator might put the subject as risk on this study.
- History of tuberculosis or a recent history of infection within the past 4 weeks.
- History of recurrent infections.
- Presence of clinically significant laboratory values during the screening period, as
defined by an Investigator.
- Presence of clinically significant vital signs values or of electrocardiogram (ECG)
abnormalities during the screening period, as defined by an Investigator.
- Subjects who have autoimmune disease or immunodeficiency, or have a family history of
related diseases.
- Subjects who have allergies, or have or are currently suffering from clinically
significant atopic allergies, hypersensitivity or allergic reactions, including known
or suspected clinically relevant hypersensitivity or allergic reactions to certain
components of the IMP preparation, or a history of allergies to other drugs or
biological agents.
- Positive screening test results for human immunodeficiency virus (HIV-1/HIV-2)
antibodies, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCVAb).
- Subjects who have received treatment with an investigational drug within 30 days or 5
times the half-life (whichever is longer) prior to screening or 90 days for biologic
compounds prior to screening.
- Subjects who have participated in any vaccine clinical study as subjects within 3
months before enrollment or plan to receive live vaccines during the study period, and
subjects who have received vaccines 28 days prior to the IMP administration or plan to
receive vaccines within 2 months after the end of the study.
- Subjects who have taken drugs that may affect immune function within 6 months before
screening, have received any monoclonal antibody or biological agent for treatment
(for any illness) within the previous 3 months, and have previous treatment with any
prescribed medications (including vaccines) or over-the-counter (OTC) medications
(including herbal medicines such as St John's Wort, homeopathic preparations,
vitamins, and minerals) within 7 days prior to IMP administration.
- Subjects whose daily consumption of coffee, tea and/or cola is more than 750 mL or 25
fl. oz in the last 30 days before enrollment.
- Subjects who have a positive urine alcohol test or urine drug test before enrollment.
- Subjects who have nicotine consumption (e.g., smoking, nicotine patch, nicotine
chewing gum, or electronic cigarettes) within 3 months prior to screening and
inability to refrain from nicotine consumption from screening until end of study.
- Female subjects who are pregnant or breastfeeding during the screening period and on
admission.
- Subjects whose daily consumption of alcohol at the time of screening or at any time
within the prior 6 months is more than 2 standard drinks, where 1 standard drink = 355
mL or 12 oz (1 can) of regular-strength (5%) beer; 150 mL or 5 oz wine; 45 mL or 1.5
oz liquor/spirits (40%).
- History of substance use disorder (within 1 year of screening).
- Subjects who have undergone major surgery within 2 months of screening, or who will
have elective surgery that will occur during the study period.
- Subjects who have donated either more than approximately 500 mL of blood (exclusive
plasma donation) within 56 days (8 weeks) prior to screening or any plasma within 7
days (1 week) prior to screening.
- Subjects fails or is unwilling to abstain from strenuous physical activities for at
least 48 hours prior to IP administration and throughout the study.
- Subjects with any factors that would, in the Investigator's judgment, preclude them
from participating in this study.
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