Език: EN EN
← Назад към резултатите
Предстои набиране Фаза 1 NCT07545226

Comparing the Extent to Which Two Evolocumab Drug Products Are Made Available in the Body After a Single Subcutaneous Dose.

Фаза 1 – тестване на безопасността при малка група хора
Заболявания: Healthy Participants

Спонсор: Amgen

Налично на: БГ
Обобщение
The primary objective of this trial is to evaluate the pharmacokinetics (PK) of two evolocumab drug products in healthy participants.
Кой може да участва
Inclusion Criteria: 1. Male or female, of any race, between 18 and 60 years of age, inclusive. a. Females must not be pregnant or lactating. 2. Body mass index (BMI) between 18.0 and 32.0 kg/m\^2 inclusive. 3. LDL-C level ≥ 70 mg/dL (1.8 mmol/L) and ≤ 190 mg/dL (4.9 mmol/L) at screening. Exclusion Criteria: 1. History or evidence of any clinically significant disorder, condition, or disease that in the opinion of the investigator (or designee) would pose a risk to participant safety or interfere with the trial evaluation, procedures, or completion. 2. History or current signs or symptoms of cardiovascular disease. 3. History or evidence of clinically significant arrhythmia. 4. History of hypersensitivity, intolerance, or allergy to evolocumab or its ingredients or other biological drugs. 5. Uncontrolled hyperthyroidism or hypothyroidism. 6. Current use or prior use of over-the-counter or other prescription medications, herbal medicines, vitamins, and supplements within 30 days or 5 half-lives prior to check-in. 7. Participation in another investigational device or drug trial within the past 30 days or 5 half-lives prior to check-in. 8. Have previously completed or withdrawn from this trial or any other trial investigating evolocumab, any other product directed against PCSK9, or have previously received evolocumab or PCSK9 inhibitor.
Интервенции
Evolocumab Drug Substance A (Test)
DRUG
Evolocumab Drug Substance B (Reference)
DRUG
Места на провеждане

Информация за локации не е налична.

Технически детайли
Статус
Предстои набиране
Фаза
Фаза 1
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
60 Years
Здрави доброволци
Не
Начална дата
20.04.2026
Крайна дата
08.09.2026
Регистрационен номер
NCT07545226
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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