Single Ascending Doses (SAD) and Multiple Ascending Doses(MAD) Study of IG001119 in Healthy Adult Participants

Официальное название

A Randomized, Double-Blinded, Placebo-Controlled, Single- and Multiple-Ascending-Dose Phase Ⅰ Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IG001119 in Healthy Participants

Обзор

The purpose of this study is to evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IG001119 in Healthy Participants

Вмешательства

• Препарат Placebo
  Tablets for oral administration.
• Препарат IG001119
  Tablets for oral administration.

Первичные конечные точки

• The incidence and severity of adverse events（AE） [Срок оценки: from ICF signing date to Day 10]
• The incidence and severity of adverse events [Срок оценки: from ICF signing date to Day 23]

Вторичные конечные точки (8)

• Time to reach the Peak Plasma Concentration (Tmax) [Срок оценки: SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18]
• Observed maximum concentration (Cmax) [Срок оценки: SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18]
• Terminal elimination half-life (t1/2). [Срок оценки: SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18]
• Area under the concentration-time curve (AUC). [Срок оценки: SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18]
• Apparent clearance (CL/F). [Срок оценки: SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18]
• Apparent volume of distribution: Vd/F. [Срок оценки: SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18]
• Elimination rate constant (λz). [Срок оценки: SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18]
• Pain tolerance time for the Cold Pain Test [Срок оценки: Day 1 to Day 1 or Day 14]

Критерии участия

Критерии включения

• Participants who have signed the informed consent form (ICF) prior to the study, fully understand the content, procedures and possible adverse reactions of the study, and are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
• Body weight ≥ 50 kg for males and ≥ 45 kg for females, with a body mass index (BMI = weight (kg)/height 2(m) 2) of 18-32 kg/m2(inclusive).
• Male and female participants who are overtly healthy as judged by the Principal Investigator (PI) or delegate including medical history, physical examination, Vital signs, 12-lead ECG, and laboratory tests. And repeat testing is permitted at the discretion of PI or delegate.

Критерии исключения

• History or presence of clinically significant acute or chronic diseases of the circulatory, endocrine, neurological, digestive, respiratory, hematological, immunological, psychiatric systems, or metabolic abnormalities, which in the opinion of the investigator, make the participant unsuitable for participation.
• History of childhood asthma (regardless of resolution), depression, migraine, or Gilbert's Syndrome.
• Hyperkalemia or hypokalemia is deemed clinically significant by the investigator.
• History of previous episodes of torsades de pointes ventricular tachycardia, or symptomatic ventricular arrhythmia, personal or family history of short QT syndrome or long QT syndrome, or first-degree family history of sudden cardiac death.
• Major surgery within 6 months prior to screening, or history of surgery that may significantly affect the pharmacokinetic profile or safety evaluation of the investigational drug (e.g., gastrectomy,cholecystectomy, liver or kidney transplantation), or planned surgery during the study.
• Participants who have received any vaccination within 1 month prior to screening or plan to receive any vaccination during the study.
• Participants who have used any medication (including prescription drugs, over-the-counter drugs, or herbal products/health supplements) within 5 half-lives or 14 days (whichever is longer) prior to dosing, or who are anticipated to require concomitant medication during the study.
• Participants with an average daily smoking habit of >5 cigarettes within 3 months prior to screening, or who are unable to refrain from smoking during the study.
• Participants deemed by the investigator to be unsuitable for participation for any other reason (e.g., assessed as being excessively sensitive or insensitive to pain), or who are otherwise unlikely to complete the study.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Австралия · 1 центр

• CMAX — Adelaide

Идентификаторы

NCT: NCT07618247 · IG001119-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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