Postoperative AnemiaPhase 2NCT07007936
Phase IIa Trial of Oral SSS17 for Post-Arthroplasty Anemia
A Phase 2 study testing SSS17 Capsule (6 Dose Levels) in people with Postoperative Anemia and Arthroplasty, Replacement, Hip, run by Shenyang Sunshine Pharmaceutical Co., LTD. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Anemia, Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee
- What is being tested?
- SSS17 Capsule (6 Dose Levels)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Jul 2025to Apr 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent obtained
- -
- Age 18-70 years (inclusive)
- -
- Candidates for hip/knee arthroplasty
- -
Show all 9Show fewer
- No DVT on pre-op venous ultrasound
- -
- Screening Hb 80-110 g/L (no transfusion indication) - 6. Commitment to effective contraception
Who cannot join
- 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
Show all 21Show fewer
- 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
- 13. 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University People's Hospital
Beijing
Jianhao Lin Ph.D, 135 0100 4301, jianhao_lin@hotmail.com
About this study
Official 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
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.
- Being tested
- SSS17 Capsule (6 Dose Levels), Placebo Drug
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 DrugDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| SSS17 | Experimental | The study employs a hybrid design with six dose levels: four fixed-dose parallel arms and two sequential dose-escalation cohort Receives: Drug: SSS17 Capsule (6 Dose Levels); Drug: Placebo Drug |
| placebo | Placebo comparator | Not described Receives: Drug: SSS17 Capsule (6 Dose Levels); Drug: Placebo Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in hemoglobin
Measured: Day 8，Day 15，Day 29
Secondary outcomes (1)
Proportion of subjects requiring transfusion and transfusion volume
Measured: Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study startJul 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AnemiaStudies of the same condition, open and under way.
- More trials run by Shenyang Sunshine Pharmaceutical Co., LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07007936
- Sponsor's protocol ID
- SSS17-202
- Status last verified
- Jun 2025
- First submitted
- 29 May 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07007936
- Acronym / sponsor ID
- SSS17-202
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.Industry (pharma, biotech, devices)
- Study start
- Jul 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SSS17 | Experimental | Drug: SSS17 Capsule (6 Dose Levels), Drug: Placebo DrugThe study employs a hybrid design with six dose levels: four fixed-dose parallel arms and two sequential dose-escalation cohort |
| placebo | Placebo comparator | Drug: SSS17 Capsule (6 Dose Levels), Drug: Placebo Drug |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed informed consent obtained
- -
- Age 18-70 years (inclusive)
- -
- Candidates for hip/knee arthroplasty
Key exclusion criteria (21 listed)
- 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:
- Active infections or carrier status including:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | SSS17, placebo |
| Placebo DrugArm2：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). | Drug | SSS17, placebo |
Primary outcome
Change from baseline in hemoglobin
Time frame: Day 8，Day 15，Day 29
1 secondary outcome
Proportion of subjects requiring transfusion and transfusion volume
Time frame: Day 29
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Postoperative Anemia
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 3
Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery)
Gynecologic Cancer, Anemia
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 4
Tranexamic Acid for Bleeding Reduction During TURP Surgery
Benign Prostatic Hyperplasia, Transurethral Resection of the Prostate
Not yet recruitingPhase 4
Ferric Carboxymaltose Versus Iron Sucrose for Iron Deficiency Anemia After Radical Gastrectomy for Gastric Cancer
Gastric Cancer (GC), Iron Deficiency Anemia (IDA)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SSS17 Capsule (6 Dose Levels) in people with Postoperative Anemia and Arthroplasty, Replacement, Hip, run by Shenyang Sunshine Pharmaceutical Co., LTD. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Professor Lin, Ph.D (010-88324516, rmyyllwyh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in hemoglobin (time frame: Day 8，Day 15，Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.