Phase IIa Trial of Oral SSS17 for Post-Arthroplasty Anemia

Shenyang Sunshine Pharmaceutical

Status and phase: Not yet enrolling; Phase 2

Conditions: Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee; Postoperative Anemia

Treatments: Drug: SSS17 Capsule (6 Dose Levels); Drug: Placebo Drug

Study type: Interventional

Funder types: Industry

Identifiers

NCT07007936

SSS17-202

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

SSS17

Experimental group

Description:

The study employs a hybrid design with six dose levels: four fixed-dose parallel arms and two sequential dose-escalation cohort

Treatment:

Drug: Placebo Drug

Drug: SSS17 Capsule (6 Dose Levels)

placebo

Placebo Comparator group

Treatment:

Drug: Placebo Drug

Drug: SSS17 Capsule (6 Dose Levels)