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临床试验/NCT05260658
NCT05260658已完成1 期

A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of CFTX-1554 in Healthy Subjects, With Comparison of Intake of CFTX-1554 as Liquid Formulation and as Capsule, and After a High-fat Breakfast Versus Fasted

Confo Therapeutics1 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2022年2月9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
已完成
入组人数
97
试验地点
1
主要终点
Number of Participants With Adverse Events

研究概览

简要总结

The study will consist of 2 parts, i.e. a single ascending dose part with integrated food effect assessment and assessment of relative bioavailability (Part A), and a multiple ascending dose part (Part B).

Part A will have a randomized, double-blind, placebo-controlled design. Subjects will receive single ascending doses of CFTX-1554 or placebo (as liquid formulation under fasted condition) in 7 subsequent cohorts. Drug intake under fed conditions, and as capsule under fasted conditions and under fed conditions (Periods 2 to 4), compared to liquid formulation under fasted conditions (Period 1) (1 single dose level only) will be assessed.

Part B will have a randomized, double-blind, placebo-controlled design, assessing multiple ascending oral doses of CFTX-1554 or placebo in 4 subsequent cohorts.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Basic Science
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Part A: CFTX-1554 Single Ascending Dose (SAD)

Experimental

Up to 7 dose levels with CFTX-1554 administered as oral liquid formulation under fasted conditions (at 1 single dose level only, drug intake under fed conditions, and as capsule under fasted conditions and under fed conditions, will be assessed)

干预措施: CFTX-1554 (Drug)

Part A placebo

Placebo Comparator

Single placebo administration in study Part A

干预措施: Placebo (Drug)

Part B: CFTX-1554 Multiple Ascending Dose (MAD)

Experimental

Up to 4 dose levels with CFTX-1554 in Part B. Doses and dosing frequency will be decided based on the results of study Part A.

干预措施: CFTX-1554 (Drug)

Part B placebo

Placebo Comparator

Multiple placebo administration in study Part B

干预措施: Placebo (Drug)

结局指标

主要结局

Number of Participants With Adverse Events

时间窗: Day -1 through Day 13 (Single Ascending Dose study part) or Day 26 (Multiple Ascending Dose study part)

Number of Participants With Adverse Events Following Oral Administration of CFTX-1554 in SAD (Part A) and MAD (Part B)

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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