临床试验/NCT06117514

NCT06117514已完成1 期

A Single-center, Randomized, Double-blind, Placebo-controlled, Dose-ascending Phase I Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of Sudapyridine (WX-081) Tablets in Healthy Chinese Subjects

Shanghai Jiatan Pharmatech Co., Ltd1 个研究点分布在 1 个国家目标入组 82 人开始时间: 2019年2月13日最近更新: 2023年11月7日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 82
试验地点: 1
主要终点: Maximum plasma concentration (Cmax) of Sudapyridine

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

The objective of this study is to evaluate the safety, tolerability as well as pharmacokinetics of Sudapyridine (WX-081) in Chinese volunteers.

详细描述

In this study, a single-center, randomized, double-blind, placebo-controlled, dose-ascending design was used to evaluate the safety, tolerability and pharmacokinetic characteristics of Sudapyridine (WX-081) tablets in healthy Chinese subjects using placebo as control.

This study was divided into two stages. The first stage evaluated the tolerance of single administration, pharmacokinetic characteristics, and the effect of food on PK. The second stage evaluated the tolerance of multiple administration and PK characteristics.

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: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 40 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Weight: ≥50 kg; 19≤ body mass index (BMI) < 26 kg/m2;
•Considered healthy by the investigator based on a detailed history, thorough physical examination, clinical laboratory examination, 12-lead ECG, and vital signs results;
•No parenting plan and reliable contraception during the trial period and within 3 months after the last dose.

排除标准

•Allergic to any drug of the same category or its ingredients;
•A history of alcohol dependence or drug abuse;
•Laboratory obvious abnormalities;
•CYP3A4 potent inducer or inhibitor had been taken within 30 days prior to enrollment;
•Any serious cardiovascular, kidney, liver, blood, tumor, endocrine and metabolic, autoimmune or rheumatic diseases.

研究组 & 干预措施

Sudapyridine 30 mg single dose

Experimental

Participants received Sudapyridine 30 mg single dose orally.

干预措施: Sudapyridine 30mg (Drug)

Sudapyridine 100 mg single dose

Experimental

Participants received Sudapyridine 100 mg single dose orally.

干预措施: Sudapyridine 100mg SAD (Drug)

Sudapyridine 200 mg single dose

Experimental

Participants received Sudapyridine 200 mg single dose orally.

干预措施: Sudapyridine 200mg SAD (Drug)

Sudapyridine 200 mg multiple doses

Experimental

Participants received Sudapyridine 200 mg orally for multiple doses.

干预措施: Sudapyridine 200mg MAD (Drug)

Sudapyridine 300 mg multiple doses

Experimental

Participants received Sudapyridine 300 mg orally for multiple doses.

干预措施: Sudapyridine 300mg MAD (Drug)

Placebo 100 mg single dose

Placebo Comparator

Participants received Placebo 100 mg single dose orally.

干预措施: Placebo tablet SAD (Other)

Placebo 200 mg single dose

Placebo Comparator

Participants received Placebo 200 mg single dose orally.

干预措施: Placebo 200mg SAD (Other)

Placebo 200 mg multiple doses

Placebo Comparator

articipants received Placebo 200 mg orally for multiple doses.

干预措施: Placebo tablet MAD (Other)

Placebo 300mg multiple doses

Placebo Comparator

Participants received Placebo 300 mg orally for multiple doses.

干预措施: Placebo tablet MAD (Other)