SSS17 Capsule (6 Dose Levels): Arm1 : This dose-ranging study evaluates 6 dose levels of oral SSS17 capsules under two regimens: Once weekly、 Twice weekly
Placebo 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).
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Change from baseline in hemoglobin — Day 8,Day 15,Day 29
Trial sites (1)
Facility
City
Region
Status
Peking University People's Hospital
Beijing
China
More Shenyang Sunshine Pharmaceutical Co., LTD. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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