Phase IIa Trial of Oral SSS17 for Post-Arthroplasty Anemia

NCT07007936 | Not Yet Recruiting Phase 2

• 1 other identifier: SSS17-202
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline in hemoglobin

  Day 8，Day 15，Day 29

Secondary Outcomes (1)

• Proportion of subjects requiring transfusion and transfusion volume

  Day 29

Study Arms (2)

SSS17

EXPERIMENTAL

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

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

placebo

PLACEBO COMPARATOR

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

Interventions

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

SSS17; placebo

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).

SSS17; placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shenyang Sunshine Pharmaceutical Co., LTD.: lead

Study Sites (1)

Peking University People's Hospital

Beijing, China

Location

MeSH Terms

Interventions

Floors and Floorcoverings

Intervention Hierarchy (Ancestors)

Facility Design and Construction; Architecture; Technology, Industry, and Agriculture

Central Study Contacts

Professor Lin, Ph.D

CONTACT

010-88324516; rmyyllwyh@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 6, 2025
• Study Start: July 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: June 11, 2025

Record last verified: 2025-06

Locations

CN (1)