NCT06506266已完成1 期
A Randomized, Double-blind, Single-site, Two-way Crossover Phase 1 Study to Assess the Effect of Repeated Doses of Test Propellant (HFA-152a) on Mucociliary Clearance as Compared to Reference Propellant (HFA-134a) in Healthy Male and Female Participants
适应症
干预措施
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
- Area Under the Percent Radiolabeled Particle Retention-time Curve up to 4 Hours [AUC(0-4h)] After Nebulized 99mTechnetium (99mTc) Inhalation on Day 7
研究概览
简要总结
The main goal of the study is to assess the effect of the administration of reference propellant [HFA-134a (1,1,1,2 - Tetrafluoroethane)] and test propellant [HFA-152a (1 - Difluoroethane)] in healthy adults on mucociliary clearance (MCC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants are eligible to be included in the study only if all following criteria apply:
- •Male or Female, age 30 to 55 years
- •Body Mass Index (BMI): 18.0 to 32.0 kg/m2, inclusive, at screening
- •Weight: ≥50 kg
- •Nonsmokers or ex-smokers for more than 6 months with a smoking history of <10 pack years
- •Status: healthy participants
- •Spirometry data.
- •Forced Expiratory Volume in 1 second (FEV1) ≥80% of predicted values.
- •FEV1: Forced vital capacity (FVC) ratio >70%.
- •Females must be of nonchildbearing potential, and agree not to donate eggs (ova, oocytes) for the purpose of reproduction during the study intervention period and at least 30 days after the last dose of study intervention.
- •Male participants are eligible to participate if they agree to:
- •Refrain from donating sperm
- •Either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent
- •Or must agree to use a male condom when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant. The female partner should additionally use a highly effective contraceptive method with a failure rate of <1% per year.
- •All prescribed medication must have been stopped at least 30 days prior to admission to the clinical research centre based on investigator judgment. An exception is made for Hormonal Replacement Therapy (HRT), and occasional paracetamol which may be used throughout the study.
- •Capable of giving written informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •Capable of using inhaler device with no physical or other issues which would impair the participant's ability to successfully use a metered dose inhaler (MDI) inhaler as instructed in this study.
- •Ability to comply with the protocol. Participants have capacity and no issues which would impair their ability to comply with all aspects of the protocol during the study
排除标准
- •Participants who meet any of the following exclusion criteria at screening will not be eligible to participate in the study:
- •Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 millisievert (mSv) in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker shall participate in the study.
- •History or presence of any form of asthma, including childhood asthma and exercise induced asthma.
- •Respiratory disorders other than asthma. A history of respiratory diseases to include (but not limited to): pneumothorax, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, cystic fibrosis, bronchiectasis, interstitial lung disease, emphysema, Chronic obstructive pulmonary disease (COPD), tuberculosis, known alpha 1 antitrypsin deficiency and other respiratory abnormalities other than asthma that, in the opinion of the investigator, could put the participant at risk through study participation or could affect the study analyses and data interpretation.
- •Recent history of mild conditions potentially affecting Mucociliary clearance (MCC) (viral infections, cough, cold, active hay fever etc.) in the last 14 days.
- •Recent use of drugs for treating conditions potentially affecting MCC (viral infections, cough, cold, etc.) in the last 30 days.
- •Vaccine(s) within 2 weeks prior to admission or plans to receive such vaccines during the study.
- •Current enrolment or past participation in this clinical study.
- •Positive human immunodeficiency virus (HIV) antibody test.
- •Regular use of known drugs of abuse, including Tetrahydrocannabinol (THC).
- •Average intake of more than 21 units of alcohol per week in males and 14 units per week in females (clinical site standard: unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits) based on breath alcohol test.
研究组 & 干预措施
HFA-152a followed by HFA-134a
Experimental
干预措施: Radiolabeled saline solution (Other)
HFA-134a followed by HFA-152a
Experimental
干预措施: Radiolabeled saline solution (Other)
HFA-134a followed by HFA-152a
Experimental
干预措施: HFA-152a (Other)
HFA-152a followed by HFA-134a
Experimental
干预措施: HFA-134a (Other)
HFA-152a followed by HFA-134a
Experimental
干预措施: HFA-152a (Other)
HFA-134a followed by HFA-152a
Experimental
干预措施: HFA-134a (Other)
结局指标
主要结局
Area Under the Percent Radiolabeled Particle Retention-time Curve up to 4 Hours [AUC(0-4h)] After Nebulized 99mTechnetium (99mTc) Inhalation on Day 7
时间窗: At 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, and 240 minutes on Day 7
\[AUC(0-4h)\] was assessed for Mucociliary clearance (MCC) in participants following administration of nebulized 99mTc on Day 7. Gamma scintigraphy was utilized to conduct assessments.
次要结局
- Percentage of Radiolabeled Particle Retention at 1 Hour After Nebulized 99mTechnetium (99mTc) Inhalation on Day 7(1 hour after inhalation on Day 7)
- Percentage of Radiolabeled Particle Retention at 1.5 Hours After Nebulized 99mTechnetium (99mTc) Inhalation on Day 7(1.5 hours after inhalation on Day 7)
- Percentage of Radiolabeled Particle Retention at 3 Hours After Nebulized 99mTechnetium (99mTc) Inhalation on Day 7(3 hours after inhalation on Day 7)
- Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)(Up to approximately 13 weeks)
研究者
研究点 (1)
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