临床试验/NCT07128654

NCT07128654已完成1 期

A Randomized, Open, Single-dose, Crossover-design, Phase I Study to Evaluate the Safety and Pharmacokinetics After Co-administration of CTL0201 and CTL0202 or Administration of CT-L02 in Healthy Volunteers

Celltrion1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2025年9月17日最近更新: 2025年11月17日

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Celltrion
入组人数: 40
试验地点: 1
主要终点: AUCt (Area under the plasma concentration-time curve)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a randomized, open, single-dose, crossover-design, phase I study to evaluate the safety and pharmacokinetics after co-administration of CTL0201 and CTL0202 or administration of CT-L02 in healthy volunteers.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: None

入排标准

年龄范围: 19 Days 至 55 Days（Child）
性别: All
接受健康志愿者: 是

入选标准

•Healthy participant aged 19 to 55 years, at screening
•A participant who has a body mass index (BMI) of 18.0~29.9 kg/m2, at screening
•A participant who is judged to be eligible to participate by the results of screening tests (vital signs, clinical laboratory tests, 12-lead ECG, etc.) by the principal investigator

排除标准

•A participant who has taken drugs that induce or inhibit drug metabolizing enzymes
•A participant who has participated in other clinical trials or bioequivalence studies within 6 months prior to the first dose of the investigational drug
•A participant who has a history of gastrointestinal surgery that may affect drug absorption

研究组 & 干预措施

Arm A

Experimental

CTL02

干预措施: CTL02 (Drug)

Arm B

Active Comparator

Co-administration of CTL0201 and CTL0202

干预措施: CTL0201 (Drug)

Arm B

Active Comparator

Co-administration of CTL0201 and CTL0202

干预措施: CTL0202 (Drug)

结局指标

主要结局

AUCt (Area under the plasma concentration-time curve)

时间窗: 0(Pre-dose), 0.17, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 48, 72hrs

Cmax (Peak Plasma Concentration)

时间窗: 0(Pre-dose), 0.17, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 48, 72hrs

次要结局

未报告次要终点

研究者

发起方

Celltrion

申办方类型

Industry

责任方

Sponsor

研究点 (1)

Loading locations...

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