Език: EN EN
← Назад към резултатите
Активно (без набиране) Фаза 1/2 NCT06471543

Study of RN0361in Adult Healthy Subjects and Adult Hypertriglyceridemic Subjects

Фаза 1/2 – комбинирано ранно изпитване
Заболявания: Hypertriglyceridemia Familial Chylomicronemia Syndrome

Спонсор: Ikaria Bioscience Pty Ltd

Налично на: БГ
Обобщение
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single doses of RN0361 in Adult healthy subjects and Adult Hypertriglyceridemic Subjects.
Кой може да участва
Phase I: Inclusion Criteria: * Willing to provide written informed consent before any study-specific procedures. * Comply with the study requirements and restrictions as listed in the Informed Consent Form and the protocol. * Fasting serum triglyceride levels \> 80 mg/dL and fasting LDL-C ≥70 mg/dL at screening * Female participants must either be nonchildbearing or, if of childbearing potential, not pregnant, not breastfeeding, and using effective contraception. Male participants must use condoms and ensure their partners use contraception if they are of childbearing potential. * Participants must avoid sperm or egg donation during the study Exclusion Criteria: * History or presence of any serious or uncontrolled disease * clinically significant health concerns * Recent vaccination with live vaccines, except for influenza, or plans to receive such during the study. * Positive tests for alcohol or drugs of abuse at screening. * History of multiple drug allergies or allergic reactions to specific components used in the study. Phase II: Inclusion Criteria: * Willing to provide written informed consent before any study-specific procedures. * Comply with the study requirements and restrictions as listed in the Informed Consent Form and the protocol. * Fasting serum triglyceride levels ≥ 300 mg/dL at screening * Female participants must either be nonchildbearing or, if of childbearing potential, not pregnant, not breastfeeding, and using effective contraception. Male participants must use condoms and ensure their partners use contraception if they are of childbearing potential. Exclusion Criteria: * History or presence of any serious or uncontrolled disease * Active pancreatitis within 12 weeks prior to Day 1 * Uncontrolled hypertension (sitting blood pressure) \>160/100 mm Hg * Uncontrolled diabetes * Symptomatic heart failure (NYHA II-IV) * Positive serologic test of HBV, HCV, or HIV * Alcohol or drugs abuse * History of multiple drug allergies or history of allergic reaction to an oligonucleotide or GalNAc. * History of intolerance to SC injection or relevant abdominal scarring (surgical, burns, etc) * History of malignancy within the last 2 years prior to the date of consent Note: Additional inclusion/exclusion ceiteria may apply, per protocol.
Места на провеждане 2
Австралия (1)
University of the Sunshine Coast Clinical Trials
Morayfield , Queensland
САЩ (1)
TBC Research LLC,
Tamarac , Florida
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 1/2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
70 Years
Здрави доброволци
Не
Начална дата
30.09.2024
Крайна дата
26.08.2026
Регистрационен номер
NCT06471543
Източник
anzctr
Запитване за медицински туризъм

Информацията е извлечена автоматично от ClinicalTrials.gov. Консултирайте се с вашия лекар преди да предприемете действия.