A Phase 1, MAD Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LY03017

Официальное название

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, MAD Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral LPM526000133 Fumarate Capsules (LY03017) in Healthy Adult Subjects.

Обзор

This is a phase 1，randomized, double-blind, placebo-controlled, MAD study to evaluate the safety, tolerability and pharmacokinetics of oral LPM526000133 Fumarate Capsules (LY03017) in healthy adult subjects

Подробное описание

Primary:

To assess the safety and tolerability of multiple oral doses of LY03017 in healthy adult subjects.

Secondary:

To assess the pharmacokinetics (PK) of LY03017 after multiple oral doses of LY03017 in healthy adult subjects.

Вмешательства

• Препарат LY03017
  administered orally
• Препарат LY03017-Placebo
  administered orally

Первичные конечные точки

• Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) [Срок оценки: up to day 9]

Вторичные конечные точки (7)

• Maximum observed concentration at steady state (Cmax,ss) of LPM526000133 in plasma [Срок оценки: up to day 9]
• Time to maximum observed concentration at steady state (Tmax,ss) of LPM526000133 in plasma [Срок оценки: up to day 9]
• Minimum observed concentration at steady state (Cmin,ss) of LPM526000133 in plasma [Срок оценки: up to day 9]
• Area Under the Concentration-Time Curve from Time Zero to Tau over a Dosing Interval at Steady State(AUC0-τ,ss）of LPM526000133 in plasma [Срок оценки: up to day 9]
• The area under the concentration-time curve from time zero extrapolated to infinity at steady state (AUC0-∞,ss) of LPM526000133 in plasma [Срок оценки: up to day 9]
• Apparent terminal elimination half-life (t1/2) of LPM526000133 in plasma [Срок оценки: up to day 9]
• Accumulation ratio (Ra) of LPM526000133 in plasma [Срок оценки: up to day 9]

Критерии участия

Критерии включения

• Subject who voluntarily participate and sign the informed consent form.
• Healthy male/female volunteers aged ≥18 and ≤ 45 years.
• Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) ≥18.5 and < 28.0 kg/m2.
• Able to comply with the lifestyle restrictions.

Критерии исключения

• Subject has a history of allergy to any component of the investigational drug or similar drugs, or allergic constitution.
• Subject has a history of clinically significant medical conditions that may interfere with the study results, including but not limited to blood system, circulatory system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, malignant tumors, mental disorders and metabolic disorders.
• Any surgical condition or condition may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects.
• Subject has clinically significant abnormalities in vital signs, laboratory tests, and ECGs, such as Pulse < 55 beats/min or > 100 beats/min, Systolic blood pressure < 90 mmHg or ≥140 mmHg, Diastolic blood pressure < 60 mmHg or ≥90 mmHg.

QT interval (QTc) ≥450 ms (Male) or 460 ms (Female) .

• Subject has used any of over-the-counter products within 7 days or prescription medications within 28 days prior to dosing.
• Subject has a history of surgery within 3 months prior to administration, or failure to recover from surgery, or having an expected surgical plan during the trial.
• Subject positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab), or syphilis seroreactivity (Trust).
• Subject has a history of alcohol abuse within 1 year or positive alcohol breath test results.
• Subject has a history of substance abuse within 1 year or a positive urine drug screen.
• Subject who has daily smoking of ≥ 5 cigarettes within 3 months.
• Subject who has special requirements for food, cannot comply with the unified diet or have dysphagia.
• Subject who has consumption of special diet (such as grapefruit, chocolate, coffee, xanthine-rich foods/drinks) within 48 hours prior to dosing and/or subject who has excessive daily consumption of tea, coffee, grapefruit juice, caffeinated beverages for nearly 3 months.
• Subject who has participated in other clinical trials within 3 months before administration.
• Subject has used blood products or being blood donor or blood loss within 3 months.
• Pregnant, lactating women, or positive pregnancy test.
• Subject who refusal to contraception, or plan to donate sperm or ovums.
• Subject who has a history of needle or blood faintness.
• Subject directly involved in this clinical trial.
• Poor compliance or other conditions which would make participation in the study unsuitable.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Mental Health Center — Шанхай

Идентификаторы

NCT: NCT06980207 · LY03017/CT-CHN-103

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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