ACTRN12618001244291终止1 期
A phase I/II study of povidone-iodine nasal spray (Nasodine”) to investigate safety and tolerability in healthy volunteers (Stage 1), and to investigate safety and efficacy in patients with the common cold (Stage 2).
Firebrick Pharma Pty Ltd0 个研究点目标入组 49 人开始时间: 2018年7月23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
- 49
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 65 Years（—）
- 性别
- All
入选标准
- •1. A healthy adult (18-55 years old)
- •2. Exhibit as no clinically relevant abnormalities as determined by past medical history, physical examination, vital signs, and laboratory tests at Screening.
- •3. Female subjects of childbearing potential must have a confirmed negative pregnancy test at the start of the study (Screening and Day -1) and also agree to abstain from sexual intercourse or use a highly effective method of birth control for the duration of the study and for 90 days after last dose of study drug, as determined by the investigator. Female participants of non-childbearing potential, defined as surgically sterilized (hysterectomy, bilateral oophorectomy or tubal ligation) or clinically documented to be postmenopausal.
- •4. Male subjects must agree to abstain from sexual intercourse or use a highly effective method of birth control with partners of childbearing potential for the duration of the study and for 90 days after last dose of study drug.
- •1. Adult (18-65) participants who have a cold or are coming down with a cold
- •2. Report at least two of the following cold symptoms – sneezing, runny nose, nasal congestion, or sore throat – and have a total Jackson score of at least 6 points. Jackson scores are simple sums of severity ratings (0 = absent, 1 = mild, 2 = moderate, 3 = severe).
- •3. Have had cold symptoms for at least 24 hours at the time they commence treatment.
- •4. Access to a smartphone or tablet.
- •5. Female subjects of childbearing potential must have a confirmed negative pregnancy test at the start of the study (Screening and Day -1) and also agree to abstain from sexual intercourse or use a highly effective method of birth control for the duration of the study and for 90 days after last dose of study drug, as determined by the investigator. Female participants of nonchildbearing potential, defined as surgically sterilized (hysterectomy, bilateral oophorectomy or tubal ligation) or clinically documented to be postmenopausal.
- •6. Male subjects must agree to abstain from sexual intercourse or use a highly effective method of birth control with partners of childbearing potential for the duration of the study and for 90 days after last dose of study drug.
排除标准
- •1. Upper respiratory tract infection in the 4 weeks prior to the first dose of investigational product
- •2. Visited a doctor in the previous 48 hours and had a diagnosis of allergic rhinitis, bacterial sinusitis or LRTI
- •3. Fever (>38 degrees Celsius), tachycardia greater than or equal to 100 bpm, bradycardia less than or equal to 50 bpm, BP greater than or equal to 160 systolic or greater than or equal to 110 diastolic or BP less than or equal to 100 systolic or less than or equal to 50 diastolic, respiratory rate greater than or equal to 20 breaths per minute
- •4. Using or intending to use a povidone-iodine gargle during the study
- •5. Previous diagnoses of nasal polyps or any ear, nose and throat pathology deemed by the Principal Investigator or delegate to affect assessment of the investigational product
- •6. Known iodine sensitivity
- •7. Previous diagnosis of thyroid disease/dysfunction
- •8. Pregnant or nursing (lactating) or planning to become pregnant
- •9. Detected illicit drug use or under the influence of alcohol
- •10. Use of systemic decongestants, decongestant nasal sprays or any other intranasal drugs or medications in the 4 weeks prior to the first dose of investigational product
- •11. Subject with presence of active or recurring clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease requiring medical treatment
- •1. Visited a doctor in the previous 48 hours and had a diagnosis of allergic rhinitis, bacterial sinusitis or LRTI
- •2. Fever (>38 degrees Celsius ), tachycardia greater than or equal to 100 bpm, bradycardia less than or equal to 50 bpm, BP greater than or equal to 160 systolic or greater than or equal to 110 diastolic or BP less than or equal to 100 systolic or less than or equal to 50 diastolic, respiratory rate greater than or equal to 20 breaths per minute
- •3. Lower respiratory tract infection signs or symptoms
- •4. Is considered too unwell based on global medical assessment
- •5. Self-reporting of normally very mild cold symptoms with a common cold, including duration of illness of < 48 hours
- •6. Previous diagnoses of nasal polyps or any ear, nose and throat pathology deemed by the Principal Investigator or delegate to affect assessment of the investigational product
- •7. Previous diagnoses of any chronic respiratory diseases, including asthma, chronic cough, COPD etc.
- •8. Known immunodeficiency
- •9. Known iodine sensitivity
- •10. Previous diagnosis of thyroid disease/ dysfunction
- •11. Pregnant or nursing (lactating) or planning to become pregnant
- •12. Any medical condition deemed by the Principal Investigator or delegate to affect assessment of the investigational product
- •14. Participated in another clinical trial within the past 30 days
- •15. Using or intending to use a povidone-iodine gargle during the study
- •16. Taking any OTC cold medications/complementary or herbal products or intending to do so (paracetamol will be available as rescue medication for disabling symptoms)
- •17. Detected illicit drug use or under the influence of alcohol as determined by routine diagnostic assays
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