A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of IRL201104 in Healthy Volunteers

Revolo Biotherapeutics1 个研究点分布在 1 个国家目标入组 24 人开始时间: 2023年5月26日最近更新: 2023年9月28日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Revolo Biotherapeutics
入组人数: 24
试验地点: 1
主要终点: Treatment Emergent Adverse Events

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 purpose of this clinical study is to assess the safety, tolerability and pharmacokinetics of repeat doses of IRL201104 given to healthy volunteers.

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: 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: 是

入选标准

•Participants must provide signed informed consent.
•Participants must be in good general health.
•Body mass index (BMI) 18 to ≤ 30 kg/m
•Contraception use by men or women .

排除标准

•Clinically significant liver, kidney disease or cardiac disease.
•Active malignancy and/or history of malignancy in the past 5 years.
•Serious local or systemic infection within 30 days prior to Screening
•Any acute illness within 30 days prior to Day
•Surgery, bone fracture or major musculoskeletal injury within the 3 months.
•Abnormal screening laboratory tests.
•Positive for human immunodeficiency virus (HIV) antibody or antigen.
•Positive hepatitis C virus (HCV) antibody or positive hepatitis B surface antigen (HBsAg).
•Positive result indicating active SARS-CoV-2 infection on Day -
•Positive urine drug screen/alcohol breath test at Screening.
•Positive Quantiferon Tuberculosis (TB) test.
•Systolic blood pressure (BP) > 150 mmHg or < 90 mmHg or diastolic BP > 90 mmHg or < 50 mmHg. Heart rate < 40 beats per minute (bpm) or > 100 bpm.
•Prolonged QT interval corrected by Fridericia's formula (QTcF) (> 450 ms for males and > 470 ms for females), cardiac arrhythmia, or any clinically significant abnormality in the resting electrocardiogram (ECG), as judged by the Investigator.
•All prescription and over-the-counter medications (including herbal medications), except for contraceptives and hormonal replacement therapy (HRT), are prohibited within 7 days prior to the first study intervention administration and throughout the entire duration of the study.
•All vaccines within 30 days prior and throughout the entire duration of the study.
•Administration of investigational product in another study within 30 days prior to the first study intervention administration, or five half-lives, whichever is longer.
•Blood donation within 30 days prior to the first study intervention administration.
•Females who are pregnant or breastfeeding.
•Failure to satisfy Investigator of fitness to participate for any other reason.
•Cigarette smokers and users of nicotine-containing products.