A Phase 1 randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of AP02 (nintedanib solution for inhalation) delivered via the eFlow® Nebulizer System in healthy volunteers

Avalyn Pharma, Inc.0 个研究点目标入组 68 人开始时间: 2024年7月4日最近更新: 2024年8月26日

适应症

试验速览

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•Subjects will be enrolled into this study only if they meet all the following criteria:
•1. Are willing and able to provide voluntary written informed consent for the healthy volunteer to participate in the study and consent will be documented.
•2. Males or females, age 18-65 years.
•3. Female healthy volunteers must be:
•- Of non-childbearing potential [surgically sterilized or post–menopausal (12 months with no menses without alternative medical cause)] OR
•- Not pregnant, breastfeeding or planning to become pregnant AND willing to comply with the medically acceptable contraceptive requirements of the study from Screening to at least 30 days after the last study drug administration.
•- Male healthy volunteers must commit to using condoms during the course of the study.
•4. Healthy volunteer’s body mass index (BMI) is between 18 and 32 kg/m2 (inclusive).
•5. Healthy volunteer is medically healthy with no clinically significant or relevant abnormalities in medical history, physical exam, vital signs, ECG, or laboratory evaluations (hematology, chemistry, and urinalysis) as assessed by the Investigator.
•6. Healthy volunteers must have an expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) ratio of >80 (FEV1/FVC > 80) via spirometry.

•Healthy volunteers who meet any of the following criteria will be excluded from participating in the study:
•1. History of previous allergy or sensitivity to nintedanib.
•2. History of reactive airways disease (including asthma or chronic obstructive pulmonary disease [COPD]), cystic fibrosis, or bronchiectasis. Patients with fully resolved childhood asthma with no recurrences or medical needs as an adult are permitted”.
•3. Healthy volunteers with known risk of gastrointestinal perforation, diverticular disease, and those who have undergone recent abdominal surgery.
•4. History of bleeding disorders or currently being treated with anticoagulants.
•5.Human Immunodeficiency Virus Positive (HIV+) Result.
•6. Active Hepatitis B or C.
•7. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or bilirubin >1.5× upper limit of normal (ULN).
•8. Clinically significant abnormality in the opinion of the PI in baseline hematology or chemistry tests.
•9. Positive for drugs of abuse or alcohol use at screening or admission to Phase 1 facility.
•10. Use of any medication, which in the opinion of the Investigator that that might interact with study drug or may lead to abnormal chemistry of hematology tests.
•11. Active respiratory tract infection within 2 weeks before IP administration.
•12. History of vasovagal collapses in past 3 years.

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