ACTRN12620000816954已完成1 期
A Double-blinded, Randomised, and Placebo-controlled Safety Study of AT-301 Nasal Spray in Healthy Adults
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
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
入排标准
- 年龄范围
- 18 Years 至 64 Years（—）
- 性别
- All
入选标准
- •Healthy volunteers will be included in the study if they meet all of the following criteria:
- •1. 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. Are non-smokers (including tobacco, e-cigarettes and marijuana) for a minimum of 1
- •month prior to the screening visit. Non-smokers with a significant history of smoking (> 5
- •pack years) are not eligible
- •4. Have a physically normal nasal structure (minor septum deviation allowable)
- •5. Body mass index (BMI) (calculated) within the range of 18 to 30 kg/m2 inclusive at the
- •screening visit, and prior to dosing
- •6. Medically healthy without clinically significant abnormalities in the opinion of the
- •investigator at the screening visit and prior to dosing on Day 1, including:
- •a. Physical examination without any clinically significant findings
- •b. Systolic blood pressure (BP) in the range of 90 to 140 mm Hg (inclusive) and diastolic BP
- •in the range of 50 to 90 mm Hg (inclusive) after at least 5 minutes in a seated position
- •c. Heart rate (HR) in the range of 45 to 100 beats/min (inclusive) after at least 5 minutes rest
- •in a semi-recumbent position
- •d. Normal body (tympanic) temperature (35.5.to 37.7°C, inclusive)
- •e. The 12-lead electrocardiogram (ECG), taken after the volunteer has been supine for at
- •least 5 minutes, 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 that
- •are not hazardous to the volunteer according to the opinion of the Investigator
- •f. No clinically significant findings in serum chemistry, haematology, coagulation and
- •urinalysis examinations as judged by the Investigator at screening
- •7. Negative cotinine, drug and alcohol tests at screening and prior to dosing on Day 1
- •8. Female volunteers must:
- •a. Be of non-child-bearing potential i.e., have follicle-stimulating hormone levels >40 IU/L
- •at screening and be surgically sterilized (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
- •b. If of childbearing potential, must have a negative pregnancy test at Screening (blood
- •test) and before the first study drug administration (pre-dose Day 1 urine test). They must
- •agree not to attempt to become pregnant, must not donate ova, and must agree to use 2
- •forms of highly effective contraceptive method for penile-vaginal intercourse from
- •signing consent until at least 30 days after the last dose of study therapy
- •9. Male volunteers, if not surgically sterilised, must agree not to donate sperm and if
- •engaging in sexual intercourse with a female partner who could become pregnant, must
- •agree to use a condom in addition to having the female partner use a highly effective
- •contraceptive method from signing the consent form until at least 64 days after the last
- •dose of study therapy
- •10. Have suitable venous access for blood sampling
- •11. Willing and able to comply with the requirements of the study protocol
排除标准
- •Healthy volunteers will be excluded from the study if there is evidence of any of the following at screening or prior to dosing on Day 1:
- •1. History or presence of the following based on self-report: of tuberculosis, asthma
- •(including childhood asthma), severe bronchial asthma, chronic obstructive pulmonary
- •disease, peptic ulcer or major pulmonary airway disease
- •2. Previous diagnoses of nasal polyps or any ear, nose and throat pathology deemed by the
- •Investigator to affect assessment of the investigational product
- •3. Active hay fever, rhinitis or cold
- •4. 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 PI to be clinically relevant
- •5. Known allergy to any of the formula components
- •6. Current obstructive pneumonia, severe pulmonary interstitial fibrosis, alveolar proteinosis
- •and allergic alveolitis caused by lung tumour
- •7. Positive serum pregnancy test for women of childbearing potential at the Screening visit
- •or positive urine pregnancy test with confirmatory serum pregnancy test prior to dosing
- •8. Females who are breastfeeding
- •9. Liver function test results (i.e., aspartate aminotransferase [AST], alanine
- •aminotransferase [ALT], and gamma-glutamyl transferase [GGT]) and total bilirubin < 1.5 x
- •fold above the upper limit of normal at the screening visit. Elevated total bilirubin
- •allowable if an isolated finding
- •10. Positive testing for active human immunodeficiency virus (HIV), hepatitis B surface
- •antigen (HBsAg), hepatitis C virus (HCV) antibodies, at the screening visit
- •11. Use of any prescription or over-the-counter medication (including herbal products, diet
- •aids, and hormone supplements) within 10 days or 5 half-lives of the medication
- •(whichever is longer) prior to the first study drug administration, except for
- •contraceptives for female participants of childbearing potential and occasional use of
- •paracetamol
- •12. Donation of blood or plasma within 30 days prior to randomization, or loss of whole
- •blood of more than 500 mL within 30 days prior to randomization, or receipt of a blood
- •transfusion within 1 year of study enrolment
- •13. Participation in another investigational clinical trial within 60 days or 5 half-lives
- •(whichever is longer) in the case of an investigational drug 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
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