Phase IIa Trial of Oral SSS17 for Post-Arthroplasty Anemia
NCT ID: NCT07007936
Last Updated: 2025-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
90 participants
INTERVENTIONAL
2025-07-31
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SSS17
The study employs a hybrid design with six dose levels: four fixed-dose parallel arms and two sequential dose-escalation cohort
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).
placebo
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
\-
2. Age 18-70 years (inclusive)
\-
3. Candidates for hip/knee arthroplasty
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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
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
18 Years
70 Years
ALL
No
Sponsors
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Shenyang Sunshine Pharmaceutical Co., LTD.
INDUSTRY
Responsible Party
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Locations
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Peking University People's Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SSS17-202
Identifier Type: -
Identifier Source: org_study_id
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