NCT07007936尚未招募2 期
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
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change from baseline in hemoglobin
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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) -
- •Commitment to effective contraception
排除标准
- •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
研究组 & 干预措施
SSS17
Experimental
The study employs a hybrid design with six dose levels: four fixed-dose parallel arms and two sequential dose-escalation cohort
干预措施: SSS17 Capsule (6 Dose Levels) (Drug)
SSS17
Experimental
The study employs a hybrid design with six dose levels: four fixed-dose parallel arms and two sequential dose-escalation cohort
干预措施: Placebo Drug (Drug)
placebo
Placebo Comparator
干预措施: SSS17 Capsule (6 Dose Levels) (Drug)
placebo
Placebo Comparator
干预措施: Placebo Drug (Drug)
结局指标
主要结局
Change from baseline in hemoglobin
时间窗: Day 8，Day 15，Day 29
次要结局
- Proportion of subjects requiring transfusion and transfusion volume(Day 29)
研究者
研究点 (1)
Loading locations...
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