ACTRN12622001025729撤回1 期
A Phase 1, Single-Arm, Exploratory Open-Label Study Investigating Safety, Tolerability, and Pharmacokinetics of Subcutaneously Administered EmtinB in Healthy Adult Volunteers
euroScientific Biopharmaceuticals Ltd0 个研究点目标入组 8 人开始时间: 2022年7月22日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 入组人数
- 8
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 60 Years（—）
- 性别
- All
入选标准
- •1. Generally healthy with the exception of those medical conditions allowed per the inclusion/exclusion criteria.
- •2. Adult male and female participants aged greater than or equal to 18 and less than or equal to 60 years at the time of screening.
排除标准
- •1. Presence or history of any cardiovascular, gastrointestinal, renal, hepatic, respiratory, hematological,lymphatic, immunological, dermatological, neurological, musculoskeletal, connective tissue, genitourinary,endocrine or psychiatric diseases or disorders, which are determined as clinically relevant by the investigator as they would make implementation of the protocol or interpretation of the study data difficult, or would put the participant at risk by participation in the study in the opinion of the investigator..
- •2. Any evidence or treatment of malignancy (other than localized basal cell cancer, squamous cell skin cancer, or cancer in situ that has been resected or successfully treated with topical therapy e.g. Aldara) within the previous 5 years.
- •3. Abnormal ECG, and deemed clinically significant by the investigator, at screening and/or Day -1 defined as; QTcF >450 msec (males) or >470 msec (females).
- •4. Clinically significant renal disease, nephrectomy, renal transplant or estimated glomerular filtration rate of <90 mL/min/1.73 m^2 at screening based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation 2009.
- •5. Abnormal vital sign findings (after resting semi-supine for 5 minutes) defined as:
- •Blood pressure that is >140 mm Hg or <90mm Hg systolic, or >90 mm Hg or <40 mm Hg diastolic at screening or Day -1.
- •Pulse rate that is <40 or >100 bpm at screening or Day -1.
- •6. Used or are using over-the-counter medications, dietary/nutritional supplements (except for occasional paracetamol, up to 2 g in any 1 day) within 7 days prior to first dose on Day 1 until completion of the EOS visit.
- •7. Used or are using prescription medications (except stable female contraceptives that must continue uninterrupted for the duration of the study) within 14 days or 5 half-lives prior to first dose on Day 1 (whichever is longer) until completion of the EOS visit.
- •8. Used or are using systemic steroids (orally or intravenously administered) within 28 days prior to first dose on Day 1 until completion of EOS visit.
研究者
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