A Trial to Assess Safety, Tolerability, and Pharmacokinetics of AN01 Inhalation Powder in Healthy Participants

Официальное название

A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Assess Safety, Tolerability, and Pharmacokinetics of AN01 Inhalation Powder in Healthy Participants

Обзор

AN01 is a selective small-molecule dual inhibitor of phosphodiesterase 3 and 4 (PDE3/4). As a potential new therapy for COPD, AN01 is expected to serve either as a monotherapy for COPD or as adjunctive therapy to current inhaled standard treatments, potentially generating synergistic complementary effects in patients requiring additional therapeutic options. The primary objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple doses of AN01 in healthy participants.

Подробное описание

The study is composed of three multiple ascending dose (MAD) cohorts in which participants will be randomly allocated to receive placebo or ascending doses of active AN01 in a double-blinded manner. An additional multiple ascending dose cohort may be added at Sponsor's discretion.

Вмешательства

• Препарат AN01
  Active study drug
• Препарат Placebo
  Placebo

Первичные конечные точки

• Incidence, severity, relationship to the investigational drug, and types of adverse events and serious adverse events [Срок оценки: Day 1 - Day 14]
• Number of participants with abnormal clinically significant physical examination (PE) results following study drug administration [Срок оценки: Day 1 - Day 14]
• Number of participants with abnormal clinically significant vital signs following study drug administration [Срок оценки: Day 1 - Day 14]
• Number of participants with abnormal clinically significant clinical laboratory results following study drug administration [Срок оценки: Day 1 - Day 14]
• Number of participants with abnormal clinically significant spirometry parameters following study drug administration [Срок оценки: Day 1 - Day 6]
• Number of participants with abnormal clinically significant respiratory assessment findings following study drug administration [Срок оценки: Day 1 - Day 6]
• Number of participants with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters following study drug administration [Срок оценки: Day 1 - Day 14]

Вторичные конечные точки (7)

• PK parameter assessed by serum AN01 concentration at specified timepoints for area under curve (AUC) [Срок оценки: Day 1 - Day 9]
• PK parameter assessed by serum AN01 concentration at specified timepoints for maximum plasma concentration (Cmax) [Срок оценки: Day 1 - Day 9]
• PK parameter assessed by serum AN01 concentration at specified timepoints for time to peak concentration (Tmax) [Срок оценки: Day 1 - Day 9]
• PK parameter assessed by serum AN01 concentration at specified timepoints for terminal elimination half life (t1/2) [Срок оценки: Day 1 - Day 9]
• PK parameter assessed by serum AN01 concentration at specified timepoints for apparent clearance volume (CL/F) [Срок оценки: Day 1 - Day 9]
• PK parameter assessed by serum AN01 concentration at specified timepoints for apparent volume of distribution (Vd/F) [Срок оценки: Day 1 - Day 9]
• PK parameter assessed by serum AN01 concentration at specified timepoints for terminal elimination rate constant (λz) [Срок оценки: Day 1 - Day 9]

Критерии участия

Критерии включения

• Healthy adults ≥18 and ≤60 years (inclusive).
• Body Mass Index (BMI) ≥18 and ≤32 kg/m2 (inclusive).
• Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, spirometry, and electrocardiogram (ECG).
• Non-smokers or former smokers who have quit for ≥2 years with a prior smoking history of <5 pack-years (pack-years defined as = cigarettes per day × years smoked; 1 pack = 20 cigarettes).
• Female participants must be non-pregnant and non-lactating, and, surgically sterile, use highly effective contraceptive methods from Screening until at least 30 days after the last dose of study drug, or post-menopausal for ≥12 months.
• Male participants must be surgically sterile, abstinent, or their partner must be surgically sterile, or if engaged in sexual relations with a woman of childbearing potential (WOCBP), the male participant and his partner must use an acceptable, highly effective contraceptive method from Screening until at least 90 days after the last dose of study drug.

Критерии исключения

• History of clinically significant (as per Investigator's judgment) upper respiratory disease or history of any significant pulmonary disease including, but not limited to, asthma, chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, and history of previous tuberculosis exposure with positive interferon gold test (without actual infection).
• Participants with any history of, or active, clinically significant disease (e.g., cardiovascular disease, chronic liver disease, psychiatric medical history, renal disease) that could interfere with the interpretation of the study results or compromise the health of the participant based on the judgment of the Investigator.
• Administration of vaccines/immunizations and/or boosters within 8 days prior to first dosing or if planned during the study.
• Any history of active infection at the time of Screening and/or within 28 days prior to first dosing.
• Any prior participation in a study with an investigational drug or device involving a biological targeted therapy, where final administration of the investigational drug or utilization of the device occurred within 24 weeks prior to first dosing.
• History of migraine headaches requiring prescription medication or occurring more than 2-4 times per month within the past 6 months.
• Use of non-tobacco vaping within 12 months prior to Screening.
• Use of any tobacco and/or inhaled marijuana product within 2 years prior to Screening.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Австралия · 1 центр

• Site 103 — Adelaide

Идентификаторы

NCT: NCT07554365 · AN-HV-1001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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