Phase IIa Trial of Oral SSS17 for Post-Arthroplasty Anemia
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShenyang Sunshine Pharmaceutical Co., LTD.
About this trial
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.
Eligibility criteria
Qualifiers
Signed informed consent obtained
Age 18-70 years (inclusive)
Candidates for hip/knee arthroplasty
No DVT on pre-op venous ultrasound
Disqualifiers
Hypersensitivity to the investigational product or any of its components
Any other condition causing chronic anemia
Coagulopathy or unstable anticoagulant dosing during screening
Serum albumin <35 g/L
Trial design
Treatments tested in this trial
- SSS17 Capsule (6 Dose Levels)
- Placebo Drug
Treatment groups
90 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov