Renal anemia
Conditions
Interventions
SAL-0951 15mg group:SAL-0951 15mg
SAL-0951 1mg group:SAL-0951 1mg
SAL-0951 5mg group:SAL-0951 5mg
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. This study has been fully understood and voluntarily signed the informed consent form, and can comply with the requirements and restrictions listed in the informed consent form; 2. 18 to 45 years old (including 18 and 45 years old) male or female subjects, and the ratio of single gender in each group is not less than 1/3; 3. During screening, male weight >=50kg, female weight >=45kg, and BMI between 19~ 25kg/m^2 (including 19kg/m^2 and 25kg/m^2); 4. During screening, the results of various examinations (including physical examination, vital signs examination, blood routine, urine routine, blood biochemistry, coagulation function, 12-lead electrocardiogram, chest radiograph, etc.) showed no abnormality or slight abnormality, but had no clinical significance according to the researchers; 5. Subjects or their partners do not plan to have a pregnancy during the study period and for 6 months after the last administration, and voluntarily use effective contraceptives (contraceptives are prohibited) to avoid pregnancy.
Exclusion criteria
Exclusion criteria: 1. Blood pregnancy test showed positive for pregnant women, lactating women, or women of childbearing age; 2. The investigator determined the presence of any disease (e.g., acute gastritis, gastrointestinal ulcer, anaphylactoid purpura, lupus erythematosus, etc.) or history (e.g., intracranial hemorrhage, intraocular hemorrhage, hemophilia, von Willebrand disease, etc.) that could alter or increase the bleeding tendency; 3. A clinically significant history of coronary heart disease, heart failure or thrombotic disease; 4. A clinically significant history of drug allergy or allergic disease (e.g., asthma, urticaria, eczematous dermatitis, etc.), or a probable/definite allergy to the study drug (including similar drugs, control drugs) and any of its excipients; 5. SBP 140 mmHg, DBP 90 mmHg, HR 100 BPM; 6. Any test results showed positive for HBsAg, HCVAb, HIVAb, syphilis antibody. 7. Any of the following drugs or treatments were used before the first administration: (1) Breast cancer resistant protein inhibitors or inducers were used within 2 weeks or 5 half-lives (decided by longest time) before first administration; (2) Organic anion transporter 1 polypeptide inhibitors were used within 2 weeks or 5 half-lives (decided by longest time) before first administration; (3) CYP2C8, CYP2C9 and CYP3A4 strong inducers or inhibitors were used within 2 weeks or 5 half-lives (decided by longest time) before first administration; (4) Any hypoxia-inducing factor proline hydroxylase inhibitors or erythropoietin drugs were used within 6 months before first administration; (5) Any prescription drugs and herbs were used within 4 weeks before first administration; (6) Any over-the-counter drugs and food supplements were used within 2 weeks before first administration; 8. Drug or medicine abuse, alcohol or tobacco abuse: (1) A history of drug or medicine abuse, or a positive urine test (morphine, methamphetamine, ketamine, dimethylene dioxymethamphetamine, tetrahydrocannabinol acid) at the time of screening; (2) Average 14 units of alcohol (1 unit equal to about 360mL beer, or 45mL white wine, or 150mL wine) was consumed per week within 3 months before screening, or alcohol respiration test results showed positive at the time of screening; (3) Average daily smoking >=5 cigarettes within 3 months before screening; 9. Blood donation or blood loss >=400mL within 3 months before screening; 10. A history of needle or blood dizziness, and determined to be of clinical significance by investigators; 11. Any other clinical research drug was used, or participated in any intervention clinical study within 3 months before screening; 12. Any other disease or history determined to be of clinical significance or may interfere with the subject's adherence to the protocol and completion of the study, or any other disease or history may significantly alter drug absorption, metabolism or clearance (including respiratory, cardiovascular, digestive, urogenital, blood, endocrine, nervous, mental, tumor and other diseases); 13. For any other reason, subject is not suitable to participate in the study as determined by investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamics;Safety evaluation;Tolerance evaluation; | — |
Countries
China
Contacts
Public ContactDongyang Liu
Peking University Third Hospital
Outcome results
None listed