ACTRN12621000704897终止1 期
A four-part study to evaluate the safety, tolerability, and efficacy of enoxaparin for inhalation, alone and in combination with N-acetylcysteine in healthy volunteers and hospitalised COVID-19 patients
Atossa Genetics Aus Pty Ltd0 个研究点目标入组 41 人开始时间: 2021年6月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 41
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 64 Years（—）
- 性别
- All
入选标准
- •Part A, B & C
- •1.Volunteers must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
- •2.Adult males and females, 18 to 64 years of age (inclusive) at the screening visit.
- •3.Be non-smokers (including tobacco, e-cigarettes and marijuana) for a minimum of 3 months prior to participation in the study. Non-smokers with a significant history of smoking (> 5 pack years) are not eligible.
- •4.Have no history or presence of tuberculosis, asthma, chronic obstructive pulmonary disease or major pulmonary airway disease (participants with history of childhood asthma but no subsequent episodes are eligible).
- •5.Body Mass Index (BMI) within the range of 18.5 to 30.0 kg/m2 inclusive at the screening visit, and on Day -1, prior to dosing.
- •6.Medically healthy without clinically significant abnormalities at the screening visit and Day -1, including:
- •a.Physical examination without any clinically relevant findings.
- •b.Systolic blood pressure in the range of 90 to 160 mm Hg (inclusive) and diastolic
- •blood pressure in the range of 50 to 95 mm Hg (inclusive) after 5 minutes in
- •supine position.
- •c.Heart rate in the range of 45 to 100 beats/min (inclusive) after 5 minutes rest in
- •supine position at the screening visit.
- •d.Body temperature, between 35.5°C and 37.7°C (inclusive).
- •e.The screening 12-lead electrocardiogram (ECG) must be within normal range
- •corrected QT interval [QTc] males less than or equal to 450 msec; females less than or equal to 470 msec) or with
- •abnormalities, which are deemed not clinically significant according to the opinion
- •of the Investigator at the screening visit.
- •f.No clinically relevant findings in serum chemistry, haematology, coagulation and
- •urinalysis examinations as judged by the Investigator at screening.
- •g.Pulmonary assessments must be within the normal range at the screening visit
- •and on Day -1, prior to dosing (forced expiratory volume in 1 second [FEV1], forced
- •vital capacity [FVC] and FEV1/FVC ratio greater than or equal to 80% of normal values; forced expiratory
- •flow over the middle one half of the FVC [FEF25-75%] > 75% of predicted;
- •h. oxygen saturation monitor greater than or equal to 95%).
- •7.Normal chest x-ray indicating no significant anomaly at the screening visit.
- •8.Negative cotinine, drug and alcohol tests at screening and Day -1.
- •9.Female volunteers must:
- •a.Be of non-child-bearing potential i.e. surgically sterilised (hysterectomy, bilateral
- •salpingectomy, bilateral oophorectomy at least 6 weeks before the screening visit) or
- •postmenopausal (where postmenopausal is defined as no menses for 12 months
- •without an alternative medical cause and a follicle-stimulating hormone level > 40
- •IU/L at the screening visit), or
- •b.If of childbearing potential, must have a negative pregnancy test at Screening and before the first study drug administration (Day -1). They must agree not to attempt to become pregnant must not donate ova, and must agree to use 2 forms of a highly effective contraceptive method
排除标准
- •Part A, B & C
- •1.History or presence of significant cardiovascular, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological or psychiatric disease, including any acute illness or surgery within the past three months determined by the Investigator to be clinically relevant.
- •2.History or presence of obstructive pneumonia, severe pulmonary interstitial fibrosis, alveolar proteinosis and allergic alveolitis caused by lung tumour.
- •3.Any history or presence of:
- •a.Coagulation abnormalities
- •b.Significant bleeding disorder
- •4.Known allergy to low molecular weight heparin (LMWH) or heparin, or heparin-induced thrombocytopenia.
- •5.Positive heparin-induced thrombocytopenia Platelet Factor 4 (PF4) antibody test at the screening visit.
- •6.Known allergy or sensitivity to N-acetylcysteine (NAC)(Part C only).
- •7.Females who are currently breastfeeding.
- •8.Positive serum pregnancy test for women of child-bearing potential at the screening visit or positive urine pregnancy test with confirmatory serum pregnancy test on Day -1.
- •9.Liver function test results (i.e., aspartate aminotransferase [AST], alanine aminotransferase [ALT], and gamma-glutamyl transferase [GGT]) and total bilirubin elevated >1.2 fold above the normal limits at the screening visit.
- •10.Positive testing for active human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at the screening visit.
- •11.Positive testing for SARS-CoV-2 viral RNA prior to check-in on Day -1 (the test should be performed between Day -3 and Day -2, with the results to be reviewed by the PI prior to check-in.
- •12.Donation of blood or plasma within 30 days prior to randomisation, or loss of whole blood of more than 500 mL within 30 days prior to randomisation, or receipt of a blood transfusion within 1 year of study enrolment.
- •13.Participation in another investigational clinical trial within 30 days or 5 half-lives (whichever is longer) prior to the first drug administration.
- •14.Any other condition or prior therapy, which, in the opinion of the Investigator, would make the volunteer unsuitable for this study, including unable to cooperate fully with the requirements of the study protocol or likely to be non-compliant with any study requirements.
- •1.Participation in any other clinical trial of an experimental treatment for COVID-19, with the exception of emergency access treatments.
- •2.Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 < 24 hours prior to study drug dosing except for remdesivir and azithromycin..
- •3.Uncontrolled hypertension (systolic blood pressure (BP) > 150 mm Hg and/or diastolic BP > 100 mmHg), unstable angina, congestive heart failure (CHF) of any New York Heart Association (NYHA) classification, serious cardiac arrhythmia requiring treatment (exceptions: atrial fibrillation, paroxysmal supraventricular tachycardia), history of myocardial infarction within 12 months of enrolment.
- •4.Hypotension requiring vasoactive peptides, such as dopamine, norepinephrine, epinephrine, or dobutamine.
- •5.Renal function impairment with Creatinine >2 mg/dL.
- •6.Liver function impairment with Bilirubin >2 mg/dL.
- •7.Platelet count <50,000/µL.
- •8.Multi-organ failure.
- •9.Documented active infection with a bacterial pathogen requiring parenteral systemic antibiotics.
- •10.Bacterial or fungal sepsis.
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