Phase IIa Trial of Oral SSS17 for Post-Arthroplasty Anemia

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase IIa Trial to Evaluate the Efficacy and Safety of Oral SSS17 Capsules in the Treatment of Anemia Following Total Hip or Knee Arthroplasty

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.

Inclusion Criteria:

1. Signed informed consent obtained

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2. Age 18-70 years (inclusive)

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3. Candidates for hip/knee arthroplasty

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4. No DVT on pre-op venous ultrasound

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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