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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SSS17 | Experimental | The study employs a hybrid design with six dose levels: four fixed-dose parallel arms and two sequential dose-escalation cohort |
|
| placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SSS17 Capsule (6 Dose Levels) | Drug | Arm1 : This dose-ranging study evaluates 6 dose levels of oral SSS17 capsules under two regimens: Once weekly、 Twice weekly |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in hemoglobin | Day 8,Day 15,Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects requiring transfusion and transfusion volume | Day 29 |
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Inclusion Criteria:
Signed informed consent obtained
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Age 18-70 years (inclusive)
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Candidates for hip/knee arthroplasty
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No DVT on pre-op venous ultrasound
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Screening Hb 80-110 g/L (no transfusion indication) - 6. Commitment to effective contraception
Exclusion Criteria:
Hypersensitivity to the investigational product or any of its components
Any other condition causing chronic anemia
Coagulopathy or unstable anticoagulant dosing during screening
Any of the following laboratory abnormalities at screening:
Active infections or carrier status including:
Acute joint injury with active trauma or infection at screening
Cognitive impairment or psychiatric disorders,current or history of epilepsy
Treatment with ESAs (erythropoiesis-stimulating agents) or HIF inhibitors within 30 days prior to dosing
History of severe thromboembolic events or hematopoietic disorders
Malignancy history
Severe cardiovascular diseases including:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Professor Lin, Ph.D | Contact | 010-88324516 | rmyyllwyh@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | China |
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| ID | Term |
|---|---|
| D005430 | Floors and Floorcoverings |
| ID | Term |
|---|---|
| D005160 | Facility Design and Construction |
| D001108 | Architecture |
| D013676 | Technology, Industry, and Agriculture |
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| Placebo Drug | 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). |
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