NCT07539415招募中1 期
A Phase 1 Clinical Trial to Assess the Safety of DWRX5003 and Relative Bioavailability to DWC202502 and DWC202503 in Healthy Adult Volunteers
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2026年5月6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
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
Phase 1 Safety and Relative Bioavailability Study of DWRX5003 in Healthy Adults
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
This study employs a partial double-blind design.
入排标准
- 年龄范围
- 19 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult volunteers aged ≥ 19 and ≤ 65 years at screening
- •Subjects with a body weight ≥ 50.0 kg to ≤ 100.0 kg and a BMI of ≥ 20.0 kg/m2 to ≤ 29.9 kg/m2 at screening
- •Subjects with no congenital disease or chronic disease requiring treatment as well as no pathologic symptoms or findings based on medical examination
- •Subjects who are determined to be eligible for this study based on results of laboratory tests, vital signs, physical examination, 12-lead electrocardiogram (ECG), etc. set and performed according to the nature of the IP at screening
- •Subjects who voluntarily decided to participate in the study and provided written consent to follow subject compliance requirements during the study after receiving a detailed explanation on this study and fully understanding the information
排除标准
- •Subjects with past or current medical history of clinically significant hepatic, renal, neurological, psychiatric, respiratory, endocrine, hematologic, oncologic, genitourinary, cardiovascular, digestive, and musculoskeletal diseases:
- •Females who are pregnant (serum-HCG positive) or breast-feeding
- •Subjects with a history of hypersensitivity (e.g., anaphylaxis or angioedema) or clinically significant hypersensitivity to the active ingredient of the IP, pharmaceutical excipients, or other drugs (e.g., GLP-1 receptor agonists)
- •Subjects with a history of skin disease (e.g., burns, skin cancer, etc.) or skin transplant surgery that could affect the absorption of the investigational product
- •Subjects with a history of acute or chronic pancreatitis
- •Subjects with a personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 (MEN2)
- •Subjects who are deemed ineligible for participation in the study by the investigator for reasons other than the above inclusion/exclusion criteria etc.
研究组 & 干预措施
DWRX5003
Experimental
DWRX5003 3 doses
干预措施: DWRX5003 (Drug)
DWC202502
Active Comparator
干预措施: DWC202502 (Drug)
DWC202503
Active Comparator
干预措施: DWC202503 (Drug)
DWRX5003P
Placebo Comparator
干预措施: DWRX5003P (Other)
结局指标
主要结局
Cmax
时间窗: Pre-dose (0 hour) up to 672 hours post-dose
AUC 0-t
时间窗: Pre-dose (0 hour) up to 672 hours post-dose
次要结局
- AUC 0-8h, AUC 0-168h, AUCinf(Pre-dose (0 hour) up to 672 hours post-dose)
- CL/F, Vd/F(Pre-dose (0 hour) up to 672 hours post-dose)
- Tmax, t½(Pre-dose (0 hour) up to 672 hours post-dose)
- Frel(Pre-dose (0 hour) up to 672 hours post-dose)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Clinical Trial to Evaluate the Safety, Pharmacokinetic Characteristics of DW5124 and DW5124-R, and the Effect of Food on DW5124 in Healthy Adult VolunteersNCT07319559Daewon Pharmaceutical Co., Ltd.55
招募中
1 期
Bioequivalence Study for the Safety and the Pharmacokinetics of DWC202313, DWC202314, and DWJ1622 in Healthy Volunteers Under Fed Condition.NCT07267221Daewoong Pharmaceutical Co. LTD.36
招募中
1 期
Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1622, DWC202313, and DWC202314 in Healthy Volunteers Under Fasting ConditionsNCT07260851Daewoong Pharmaceutical Co. LTD.40
尚未招募
1 期
Evaluate the Safety, Tolerability and Pharmacokinetics of DW5524 in Healthy Adult VolunteersNCT07349589Daewon Pharmaceutical Co., Ltd.48
已完成
1 期
A Phase I, Single-arm, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of Orialpha (BD-C) in Healthy Adult VolunteersBreast CancerNCT07300202Oriplantee Company Limited15