Phase IIa Trial of Oral SSS17 for Post-Arthroplasty Anemia

Launched by SHENYANG SUNSHINE PHARMACEUTICAL CO., LTD. · Jun 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called SSS17, which is taken in capsule form, to see if it can help patients who develop anemia (a low level of red blood cells) after undergoing hip or knee replacement surgery. The main goals of the trial are to check how safe the medication is, how well it works, and how it behaves in the body. The trial is not yet recruiting participants, but when it starts, it will involve adults aged 18 to 70 who are preparing for surgery and meet certain health criteria.

To participate in this study, individuals must be able to give their consent and have specific blood count levels, among other health requirements. They should not have conditions that could complicate the study, like certain chronic anemias or active infections. If you or a loved one are considering participating, you can expect to take the medication and be monitored by healthcare professionals to ensure safety throughout the trial. This study aims to find better treatments for anemia after surgery, ultimately improving recovery for patients.

Gender

ALL

Eligibility criteria

• 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