A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Study of C16TR for Inhalation to Determine Its Safety, Tolerability, and Pharmacokinetics With an Open-label Tyvaso® Cohort in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of Participants who Experienced an Adverse Event (AE)
研究概览
简要总结
The primary purpose of this study is to determine the safety and tolerability of escalating doses of C16TR for inhalation in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have a body weight between 50 and 120 kg (females) or between 55 and 120 kg (males), inclusive, with a body mass index (BMI) between 19.0 and 32.0 kilograms per square meter (kg/m^2), inclusive, at screening.
- •Have a medical history, physical examination, vital signs, electrocardiogram (ECG) and clinical laboratory results within normal limits or considered not clinically significant by the Investigator at screening.
- •Do not take any systemic or topical prescription, or nonprescription (over-the-counter [OTC]) medication (acetaminophen or ibuprofen are permitted upon principal investigator [PI] discretion) within 2 weeks or 5 half-lives (whichever is longer) before first dose of the study drugs until discharge from the study (unless prescribed by the Investigator to treat an AE).
- •Agree to abstain from consuming alcohol at least 3 days prior to in-clinic confinement until discharge from the study.
排除标准
- •Have a history of anaphylaxis, a previous documented hypersensitivity reaction, or a clinically significant idiosyncratic reaction to any drug.
- •Have a clinically significant history of neurological, cardiovascular, respiratory, endocrine, hematological, hepatic, renal, gastrointestinal, genitourinary, pulmonary, and/or musculoskeletal disease; glaucoma; a psychiatric disorder, or any other chronic disease, whether controlled by medication or not.
- •Have a history of orthostatic hypotension, or unexplained syncope.
- •Have a history of additional risk factors for Torsades de Pointes (eg, heart failure, family history of Long QT Syndrome).
- •Are positive for human immunodeficiency virus (HIV) infection, hepatitis B surface antigen (HBsAg), or the hepatitis C virus (HCV) antibody at screening.
- •Are users or former users of nicotine-containing products with > 10 pack-years of tobacco use history (including but not limited to cigarettes, cigars, and chewing or dipping tobacco), or users who stopped use or consumption (i.e., smoking, chewing, or pinching) of these nicotine-containing products less than 6 months before study drug administration or were using or had used topical or oral nicotine preparations for smoking cessation within the past 3 months before study drug administration.
- •Have a history of alcohol abuse or a history of or current impairment of organ function reasonably related to alcohol abuse.
- •Have a history or current evidence of abuse of licit or illicit drugs or a positive urine test for drugs of abuse.
- •Have a history of abnormal bleeding tendencies.
- •Donated any plasma within 7 days prior to first dosing, or has donated blood in excess of 450 mL, or had significant blood loss within 56 days prior to first dosing.
- •Have any flu-like syndrome or other respiratory infection within 2 weeks of Day 1 or having been vaccinated with an attenuated live virus within 4 weeks of Day
- •Have a history of major surgery within 4 weeks or minor surgery within 2 weeks of screening.
- •Note: Other inclusion/exclusion criteria may apply.
研究组 & 干预措施
Cohort 3: C16TR Dose C or Placebo
Participants were randomized to receive a single dose of C16TR for inhalation (Dose C) or matching placebo on Day 1 in Cohort 3.
干预措施: Placebo (Drug)
Cohort 3: C16TR Dose C or Placebo
Participants were randomized to receive a single dose of C16TR for inhalation (Dose C) or matching placebo on Day 1 in Cohort 3.
干预措施: C16TR (Drug)
Cohort 1: Tyvaso®+C16TR Dose A or Tyvaso®+Placebo
Participants received a single dose of Tyvaso® on Day 1, then randomized to receive either a single dose of C16TR for inhalation (Dose A) or matching placebo on Day 2 in Cohort 1.
干预措施: C16TR (Drug)
Cohort 1: Tyvaso®+C16TR Dose A or Tyvaso®+Placebo
Participants received a single dose of Tyvaso® on Day 1, then randomized to receive either a single dose of C16TR for inhalation (Dose A) or matching placebo on Day 2 in Cohort 1.
干预措施: Placebo (Drug)
Cohort 1: Tyvaso®+C16TR Dose A or Tyvaso®+Placebo
Participants received a single dose of Tyvaso® on Day 1, then randomized to receive either a single dose of C16TR for inhalation (Dose A) or matching placebo on Day 2 in Cohort 1.
干预措施: Tyvaso® (Drug)
Cohort 2: C16TR Dose B or Placebo
Participants were randomized to receive a single dose of C16TR for inhalation (Dose B) or matching placebo on Day 1 in Cohort 2.
干预措施: C16TR (Drug)
Cohort 2: C16TR Dose B or Placebo
Participants were randomized to receive a single dose of C16TR for inhalation (Dose B) or matching placebo on Day 1 in Cohort 2.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants who Experienced an Adverse Event (AE)
时间窗: Up to 32 days
Safety and tolerability of escalating doses of C16TR for inhalation in healthy participants.
次要结局
- Area Under the Plasma Concentration-time Curve (AUC) of Treprostinil and C16TR Post C16TR for Inhalation Dose(At multiple timepoints post dose on Days 2 to 4)
- Cohort 1: AUC of Treprostinil Post Tyvaso® Dosing(At multiple timepoints post dose on Days 1 and 2 for Cohort 1)
- Mean Change From Baseline in Corrected QT Interval by Fridericia (QTcF) for C16TR(Baseline up to Day 4 (Cohort 1) and Day 3 (Cohorts 2, 3, 4, and 5))