Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07007936

Phase IIa Trial of Oral SSS17 for Post-Arthroplasty Anemia

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent obtained

-

  • Age 18-70 years (inclusive)

-

  • Candidates for hip/knee arthroplasty

-

  • No DVT on pre-op venous ultrasound

-

  • 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:
  • Serum albumin <35 g/L
  • ALT or AST >3×ULN
  • 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)
  • 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:
  • Unstable coronary artery disease
  • Heart failure (NYHA Class III/IV)
  • Myocardial infarction/stroke 12 .Poorly controlled hypertension
  • 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

Treatment and study plan

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

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).

Primary outcomes

  1. Change from baseline in hemoglobin

    Time frame: Day 8,Day 15,Day 29

Secondary outcomes

  1. Proportion of subjects requiring transfusion and transfusion volume

    Time frame: Day 29

Study contacts

Contact information is provided by the study sponsor or research team.

Professor Lin, Ph.D

CONTACT

[email protected]

010-88324516

Sponsors and collaborators

Lead sponsor

Shenyang Sunshine Pharmaceutical Co., LTD.

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase IIa Trial to Evaluate the Efficacy and Safety of Oral SSS17 Capsules in the Treatment of Anemia Following Total Hip or Knee Arthroplasty

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 6, 2025
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.