Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee, Postoperative Anemia
Conditions
Brief summary
To assess the safety, tolerability, efficacy, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of orally administered SSS17 capsules in patients with postoperative anemia following elective total hip or knee arthroplasty.
Interventions
DRUGSSS17 Capsule (6 Dose Levels)
Arm1 ： This dose-ranging study evaluates 6 dose levels of oral SSS17 capsules under two regimens: Once weekly、 Twice weekly
DRUGPlacebo Drug
Arm2：placebo The placebo intervention was matched with the six dose levels of SSS17, with each dose level assigning participants in a ratio of 4:1 (SSS17 to placebo).
Sponsors
Shenyang Sunshine Pharmaceutical Co., LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent obtained \- 2. Age 18-70 years (inclusive) \- 3. Candidates for hip/knee arthroplasty \- 4. No DVT on pre-op venous ultrasound \- 5. Screening Hb 80-110 g/L (no transfusion indication) - 6. Commitment to effective contraception
Exclusion criteria
1. Hypersensitivity to the investigational product or any of its components 2. Any other condition causing chronic anemia 3. Coagulopathy or unstable anticoagulant dosing during screening 4. Any of the following laboratory abnormalities at screening: 1. Serum albumin \<35 g/L 2. ALT or AST \>3×ULN 5. Active infections or carrier status including: * Known HIV infection * Active syphilis * Active HBV infection (HBsAg-positive with HBV DNA \>10³ copies/mL) * Active HCV infection (anti-HCV positive with detectable HCV RNA) 6. Acute joint injury with active trauma or infection at screening 7. Cognitive impairment or psychiatric disorders,current or history of epilepsy 8. Treatment with ESAs (erythropoiesis-stimulating agents) or HIF inhibitors within 30 days prior to dosing 9. History of severe thromboembolic events or hematopoietic disorders 10. Malignancy history 11. Severe cardiovascular diseases including: * Unstable coronary artery disease * Heart failure (NYHA Class III/IV) * Myocardial infarction/stroke 12 .Poorly controlled hypertension 13\. Alcohol abuse 14.Pregnancy or lactation 15.Participation in other drug trials within 3 months prior to enrollment 16.Any other condition deemed by the Investigator to compromise subject safety or trial validity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in hemoglobin | Day 8，Day 15，Day 29 |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects requiring transfusion and transfusion volume | Day 29 |
Countries
China
Contacts
Primary ContactProfessor Lin, Ph.D
Outcome results
None listed