A Randomized, Double-blind, Placebo-controlled Multiple-ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AP303 Following 2-week Oral Administration in Healthy Chinese Participants.

Alebund Pharmaceuticals1 个研究点分布在 1 个国家目标入组 18 人2024年3月18日

适应症Healthy Subjects

干预措施AP303 150 μg AP303 300 μg Placebo 150 μg Placebo 300 μg

概览

阶段: 1 期
干预措施: AP303 150 μg
疾病 / 适应症: Healthy Subjects
发起方: Alebund Pharmaceuticals
入组人数: 18
试验地点: 1
主要终点: AUC0-t
状态: 已完成
最后更新: 去年

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

The study will be a single center, double-blind, randomized, placebo-controlled, multiple-ascending-dose study to evaluate the safety, tolerability, PK and PD of AP303 following 2-week oral administration to healthy Chinese participants.

详细描述

Eligible study participants will be enrolled and randomized into one of the two dose cohorts, each cohort will include 9 participants randomized to AP303 and placebo at 2:1 ratio (6 on AP303 and 3 on placebo).

注册库

clinicaltrials.gov

开始日期

2024年3月18日

结束日期

2024年5月13日

最后更新

去年

研究类型

Interventional

研究设计

Sequential

性别

All

研究者

发起方

Alebund Pharmaceuticals

责任方

Sponsor

入排标准

入选标准

•Healthy male and female participants, 18-50 years of age.
•BMI (body mass index) 18-27 kg/m
•Important Exclusion criteria:
•History or symptoms of any clinically significant kidney, liver, broncho-pulmonary, gastrointestinal, neurological, psychiatric, cardiovascular, endocrine/metabolic, hematological disease or cancer.
•Personal history of congenital long QT syndrome or family history of sudden death.
•People with a history of specific severe allergies, or severe allergic conditions or known allergies to the study or any of its ingredients or excipients as judged by the investigator, or any acute confirmed significant allergic reactions to any drug, or multiple drug severe allergies (non-active hay fever is acceptable). Allowing for childhood asthma, history of mild eczema that has had no flare ups for ≥5 years or is fully resolved.
•History of having received or currently receiving any systemic anti-neoplastic or immunomodulatory treatment (including systemic oral or inhaled corticosteroids) ≤6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study.
•Participants who have had significant acute infection, e.g., COVID-19, influenza, local infection, acute gastrointestinal symptoms or any other clinically significant illness within two weeks before study drug administration.
•Confirmed systolic BP greater than 140 or less than 90 mmHg, and diastolic BP greater than 90 or less than 50 mmHg at screening.
•Abnormalities of ECG parameters and abnormal shape of ECG wave on screening ECG.