| Eligibility |
Inclusion Criteria:
- Healthy subjects:
1. Able to understand the trial procedures and possible risks, volunteers to participate
in the trial, willing and able to comply with all scheduled visits and study
procedures, and provides written informed consent.;
2. Male and female, 18 to 70 years of age, inclusive;
3. Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive;
4. Normal glomerular filtration rate;
5. No clinically significant abnormalities in physical examination, vital signs,
laboratory tests, 12-lead ECG, etc. at the investigator's discretion;
6. Men and WOCBP must agree to take highly effective contraceptive methods detailed in
the protocol, have no plan to have a child from signing the consent form until at
least one month after IP administration, and must not undertake for sperm/egg
donation. Female participants should not be lactating.
Renal impairment subjects:
1. Able to understand the trial procedures and possible risks, volunteers to participate
in the trial, willing and able to comply with all scheduled visits and study
procedures, and provides written informed consent.;
2. Male and female, 18 to 70 years of age, inclusive;
3. Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive;
4. Glomerular filtration rate between 30 to 89 mL/min, inclusive;
5. Except for renal impairment and related complications, no clinically significant
abnormalities in physical examination, vital signs, laboratory tests, 12-lead ECG,
etc. at the investigator's discretion;
6. Men and WOCBP must agree to take highly effective contraceptive methods detailed in
the protocol, have no plan to have a child from signing the consent form until at
least one month after IP administration, and must not undertake for sperm/egg
donation. Female participants should not be lactating.
Exclusion Criteria:
- Healthy subjects:
1. Known history or suspected of being allergic to study drug or any component of it, or
significant allergic reactions to other biologic products and drugs, or severe food
allergies;
2. Clinically significant abnormalities in 12-Lead ECG;
3. Severe infections, injuries, or major surgeries as determined by the investigator
within 3 months prior to screening, or plans to have surgeries during the study;
4. Receipt of medical devices or another investigational drug (including placebo) within
3 months or 5 half-lives, whichever is longer prior to screening, or plans to
participate in another clinical study during this study;
5. Use of any prescription medicine, over-the-counter medicine, herbal remedy, or
nutritional supplement within 2 weeks prior to screening;
6. Consumption of more than 14 units of alcohol per week within 6 months prior to
screening, or incapable to refrain from consuming alcohol during the study, or
positive alcohol breath test result;
7. Consumption of more than 5 cigarettes daily (or products with an equivalent amount of
nicotine) within 3 months prior to screening, or use of any tobacco products 48 hours
prior to dosing;
8. History of illicit or prescription drug abuse or addiction in the past 5 years, or
illicit or prescription drug abuse within 3 months prior to screening, or positive
urine drug screen;
9. Unwilling or unable to comply with the contraceptive methods detailed in this
protocol;
10. Positive hepatitis B virus, hepatitis B core antibody, hepatitis C virus, human
immunodeficiency virus, or syphilis at screening;
11. History or evidence of clinically significant disorders and deemed not suitable to
participate in the study by the investigator within 6 months prior to screening;
12. Inability to tolerate venipuncture blood collection;
13. Any other circumstances that, in the investigator's judgment, may increase the risk to
the subject, or associated with the subject's participation in and completion of the
study.
Renal impairment subjects:
1. History of kidney transplant or plan to receive a kidney transplant during the trial;
2. Known history or suspected of being allergic to study drug or any component of it, or
significant allergic reactions to other biologic products and drugs, or severe food
allergies;
3. Clinically significant abnormalities in 12-Lead ECG;
4. Severe infections, injuries, or major surgeries as determined by the investigator
within 3 months prior to screening, or plans to have surgeries during the study;
5. Receipt of medical devices or another investigational drug (including placebo) within
3 months or 5 half-lives, whichever is longer prior to screening, or plans to
participate in another clinical study during this study;
6. Except for treatment of renal impairment and related complications, use of other
prescription medicine, over-the-counter medicine, herbal remedy, or nutritional
supplement within 2 weeks prior to screening;
7. Consumption of more than 14 units of alcohol per week within 6 months prior to
screening, or incapable to refrain from consuming alcohol during the study, or
positive alcohol breath test result;
8. Consumption of more than 5 cigarettes daily (or products with an equivalent amount of
nicotine) within 3 months prior to screening, or use of any tobacco products 48 hours
prior to dosing;
9. History of illicit or prescription drug abuse or addiction in the past 5 years, or
illicit or prescription drug abuse within 3 months prior to screening, or positive
urine drug screen;
10. Unwilling or unable to comply with the contraceptive methods detailed in this
protocol;
11. Positive hepatitis B virus, hepatitis B core antibody, hepatitis C virus, human
immunodeficiency virus, or syphilis at screening;
12. History or evidence of clinically significant disorders and deemed not suitable to
participate in the study by the investigator within 6 months prior to screening;
13. Inability to tolerate venipuncture blood collection;
14. Any other circumstances that, in the investigator's judgment, may increase the risk to
the subject, or associated with the subject's participation in and completion of the
study.
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