NCT07827027尚未招募1 期
Evaluation of the Bioequivalence of RAY1225 Injection in Healthy Participants in a Single-center, Randomized, Open-label, Parallel Study
Guangdong Raynovent Biotech Co., Ltd0 个研究点目标入组 68 人开始时间: 2026年9月21日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 68
- 主要终点
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of RAY1225 From Time Zero to T (AUC[0-t])
研究概览
简要总结
This is a single-center, randomized, open, parallel-designed bioequivalence study aimed at evaluating the pharmacokinetic differences of RAY1225 injection after site and batch changes compared to before the changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signature of a dated Informed Consent Form (ICF) indicating that the subject has been informed of all the relevant aspects(including adverse events) of the trial prior to enrollment.
- •Participants must be willing and able to adhere to the visit schedule and protocol requirements and be available to complete the study.
- •Participants (including partners) must use reliable methods of contraception during the study and until 3 months following the last dose of investigational product.
- •Body weight is no less than 55 kg in males and no less than 50 kg in females. Body mass index (BMI) 22≤BMI<28 kg/m2.
排除标准
- •A history of medullary thyroid carcinoma (MTC) or current diagnosis of MTC, or a family history of MTC (grandparents, parents, and siblings), or a diagnosis of multiple endocrine neoplasia type 2 (MEN2);
- •A history of hypoglycemic episodes within 12 months prior to screening;
- •Major surgery or severe infection within 12 weeks prior to screening;
- •Acute illness occurring from the time of signing the informed consent form to the administration of the investigational drug;
- •Clinically significant abnormalities in physical examination, vital signs, laboratory tests (complete blood count, blood biochemistry, urinalysis, coagulation function, serum calcitonin), thyroid ultrasound, abdominal color Doppler ultrasound (liver, gallbladder, pancreas, spleen, and kidneys), or chest X-ray (posteroanterior and lateral views);
- •Positive for any of the following at screening: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or Treponema pallidum antibody (TP-Ab);
- •Clinically significant abnormalities on 12-lead electrocardiogram (ECG) at screening, or QTcF > 450 ms on ECG, or a family history of long QT syndrome or Brugada syndrome;
- •Vaccination within 4 weeks prior to screening, or planned vaccination during the trial period;
- •Use of any prescription drugs, over-the-counter drugs, or traditional Chinese medicines within 4 weeks prior to screening, or planned concomitant use during the trial period.
研究组 & 干预措施
group B
Active Comparator
Single subcutaneous injection of RAY1225 3mg(reference formulation)
干预措施: RAY1225 (Drug)
group A
Experimental
Single subcutaneous injection of RAY1225 3mg (test formulation)
干预措施: RAY1225 (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of RAY1225 From Time Zero to T (AUC[0-t])
时间窗: Baseline through Day 43
PK: Maximum Concentration of RAY1225
时间窗: Baseline through Day 43
次要结局
- Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE)(Baseline through Day 43)
研究者
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