Phase IIa Trial of Oral SSS17 for Post-Arthroplasty Anemia

Phase 2

Not yet recruiting

• Conditions: Postoperative Anemia; Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee
• Interventions: Drug: SSS17 Capsule (6 Dose Levels); Drug: Placebo Drug

• Registration Number: NCT07007936
• Lead Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-29
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-05
• Study First Posted: 2025-06-06
• Last Update Submitted: 2025-06-06
• Last Update Posted: 2025-06-11
• Study Start: 2025-07
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Signed informed consent obtained

2. Age 18-70 years (inclusive)

3. Candidates for hip/knee arthroplasty

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

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

12. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SSS17	SSS17 Capsule (6 Dose Levels)	The study employs a hybrid design with six dose levels: four fixed-dose parallel arms and two sequential dose-escalation cohort
SSS17	Placebo Drug	The study employs a hybrid design with six dose levels: four fixed-dose parallel arms and two sequential dose-escalation cohort
placebo	SSS17 Capsule (6 Dose Levels)	-
placebo	Placebo Drug	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in hemoglobin	Day 8，Day 15，Day 29

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects requiring transfusion and transfusion volume	Day 29

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, China