An Open-label, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of LYN-163 in Healthy Volunteers

yndra®Therapeutics, Inc. (Lyndra)0 个研究点目标入组 15 人开始时间: 2021年9月10日最近更新: 2023年11月20日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 15

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Non-randomised trial
主要目的: Prevention
盲法: Open (masking not used)

入排标准

年龄范围: 18 Years 至 49 Years（—）
性别: All

入选标准

•1. Men and women aged 18 to 49 years of age at the time of consent.
•2. Individuals in good current health, in the Investigator’s opinion, as evidenced on review of medical history that includes no significant GI abnormalities, physical examination, concomitant medications, and other safety assessments.
•3. Body weight greater than or equal to 56 kg.
•4. Body mass index greater than or equal to 18.5 kg/m2 and less than or equal to 33 kg/m2.
•5. Able to read and understand study procedures and provide written informed consent before the initiation of any protocol-specific procedures.
•6. Willing to comply with all protocol-specified procedures and availability for the duration of the study.

排除标准

•1. Individuals with known clinically significant esophageal or GI disease, including but not limited to:
•a. Known strictures such as esophageal web, pyloric stenosis, or small intestinal stricture, or individuals with high risk of stricture, i.e., Crohn's disease.
•b. Diagnosis of a condition known to elevate or lower gastric pH, e.g., achlorhydria or hypochlorhydria.
•c. Prior varices or small or large bowel obstructions.
•d. Prior abdominal or upper gastrointestinal surgery. (Prior uncomplicated laparoscopic procedures are permitted.)
•e. History of dysphagia or aspiration in the last 5 years.
•f. History of an esophageal motility disorder or undergoing treatment for a gastric motility disorder.
•g. Multiple episodes of abdominal pain in the prior 3 months.
•h. Moderate or severe dysmenorrhea or menorrhagia (with use of pain medication) in the prior 3 months.
•2. History of moderate to severe Acid Reflux Disease or a score of greater than or equal to 2 on the Acid Reflux Severity Scale (ARSS), indicating moderate to severe symptoms. The ARSS scale is as follows:
•None = 0 no symptoms.
•Mild = 1 awareness of symptom, but easily tolerated.
•Moderate = 2 discomfort sufficient to cause interference with normal activities.
•Severe = 3 incapacitating, with inability to perform normal activities.
•3. Individuals with PILL-5 questionnaire score of 5 or greater.
•4. Medical history or current diagnoses indicating the presence of any of the following conditions:
•a. Presence of an uncontrolled, unstable, clinically significant medical condition that could put the participant at risk because of participation in the study, interfere with the participant’s ability to participate in the study or influence the interpretation of safety or PK evaluations.
•b. History of a major cardiovascular event (myocardial infarction, cardiac surgery or revascularization, unstable angina, stroke, or transient ischemic attack) or a hospitalization forheart failure within 6 months of Screening.
•c. Any clinically significant illness, medical or surgical procedure, or trauma within 4weeks of Screening.
•d. Known immunocompromised status, including individuals who have undergone organ transplantation, on immunosuppression therapy for an immune mediated disease, or are positive for human immunodeficiency virus (HIV).
•e. Positive test for active hepatitis B or C at Screening. Individuals with successfully treated hepatitis B infection which has been resolved for greater than 1 year or successfully treated hepatitis C infection will not be excluded.
•f. Donated more than 250 mL of blood within 4 weeks of Screening.
•g. Difficulties with venipuncture/cannulation, including difficulty accessing veins for blood sampling and/or history of coagulopathy or endocarditis.
•h. Active SARS-CoV-2 infection
•5. Use of the following medications/treatments in the 2 weeks before enrollment, including:
•a. Warfarin.
•b. Proton pump inhibitors.
•c. H2 blockers.
•d. Prokinetic agents.
•e. Concomitant medications, natural remedies, supplements, or vitamins. Use of antacids is permissible, except within 2 hours of dosing with LYN-163.
•f. Non-steroidal anti-inflammatory drugs or acetylsalicylic acid.
•g. Medications that may interfere with the absorption, metabolism, or excretion of ivermectin.
•h. Hormonal contraceptives.
•6. Use of blood products within 3 months of Screening.
•7. Clinically significant abnormal safety (e.g.,physical examination, vital signs) or laboratory

研究者

发起方

yndra®Therapeutics, Inc. (Lyndra)

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