ACTRN12624001064594尚未招募2 期
Randomised, double-blind, placebo-controlled, single-centre investigation of the safety, tolerability and pharmacokinetics of 0.03% SSTK-101 nasal and oral spray as single or multiple administrations in healthy volunteers
SKYDD Biotechnology Pty Ltd0 个研究点目标入组 38 人开始时间: 2024年9月3日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 38
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
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •1. Healthy male or female aged at least 18 years at the time of provision of written informed consent.
- •2. Body weight at least 50 kg with a body mass index at least 18.0 and not greater than 32.0 kg/m2 (inclusive).
- •3. Willing to use adequate contraception for the duration of the study.
- •4. In the opinion of the Investigator, is in a good state of health, as indicated by a
- •comprehensive clinical assessment (detailed medical history and a complete physical
- •examination), electrocardiogram (ECG), vital signs, and laboratory investigations.
- •(haematology, clinical chemistry, coagulation, and urinalysis) and be able to participate in all scheduled evaluations, likely to complete all required tests, and likely to be compliant with all.
- •6. Willing and able to read, understand, and sign the participant information and consent form.
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •1. Have received any investigational drug or device in a clinical research study within the
- •previous 30 days prior to screening or 5 half-lives for investigational drug, whichever is
- •2. Have positive hepatitis B surface antigen, hepatitis C antibody or human immunodeficiency virus antibody testing at screening.
- •3. Are current smokers of e-cigarettes or nicotine products and those who have used on average more than 3 of these products per month within the last 6 months.
- •4. Have a history of or active drug or alcohol abuse in the past 2 years (defined as more than 10 standard drinks per week (100 g pure alcohol) per week or 4 standard drinks per day on
- •average; where 1 standard drink contains 10 g alcohol, for example ~250 mL beer, 100 mL
- •red wine, 30 mL spirits (Alcohol and Drug Foundation, 2023; Australian Government
- •Department of Health and Aged Care, 2023).
- •5. Have a positive urine drug test at screening or admission (amphetamines, barbiturates,
- •benzodiazepines, cannabinoids, cocaine and opiates) and/or a positive alcohol breath test at screening or during the inpatient period.
- •6. Are pregnant or lactating, or have a partner who is pregnant or lactating.
- •7. Have an allergy to eggs or egg products.
- •8. Have a known or suspected autoimmune disease or impairment / alteration of immune
- •function resulting from congenital or acquired immunodeficiency, or receipt of
- •immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, and other immunosuppressive therapy as per investigator discretion.
- •9. History of nasal surgical procedures (e.g. turbinectomy, rhinoplasty etc), or a history of
- •recurrent nose bleeds, rhinitis, sinusitis, or oral infections or injuries of any type.
- •10. Have clinically significant allergic, haematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, renal, psychiatric, or neurological disease that would prevent the participant from participating in the study, including the presence of laboratory abnormalities that may place the participant at unacceptable risk if they were to participate in the study.
- •11. Taking, or have taken, any prescribed or over-the-counter drug (other than paracetamol, or hormone replacement therapy and hormonal contraception) or herbal remedies in the 14 days prior to the first dose of investigational intervention. Exceptions may apply on a case-by-case basis, if considered not to interfere with the objectives of the study, as agreed by the principal investigator and sponsor’s medical monitor.
- •12. Taking, or have taken, any anti-viral drug in the 14 days prior to the first dose of
- •investigational intervention.
- •13. Received any vaccination within 14 days prior to the first dose of investigational
- •intervention.
- •14. Have a positive SARS-CoV-2 test or Influenza A or B or RSV by PCR or Rapid Antigen Test within 12 weeks of screening.
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