Phase IIa Trial of Oral SSS17 for Post-Arthroplasty Anemia
NCT07007936 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2025-06-11
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.
Conditions
- Postoperative Anemia
- Arthroplasty, Replacement, Hip
- Arthroplasty, Replacement, Knee
Interventions
- DRUG
-
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
- DRUG
-
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).
Sponsors & Collaborators
-
Shenyang Sunshine Pharmaceutical Co., LTD.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-31
- Primary Completion
- 2026-04-30
- Completion
- 2026-04-30
Countries
- China
Study Locations
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