ACTRN12621001479897已完成1 期
A Phase 1, Open label, Single Ascending Dose Study of Intravenous and Oral Doses of BRN-002 to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy Subjects
Beren Therapeutics, PBC0 个研究点目标入组 29 人开始时间: 2021年10月29日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 29
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 65 Years（—）
- 性别
- All
入选标准
- •1. Healthy subjects aged 18 to 65 years old, both inclusive
- •2. Normal audiogram at screening
- •3. Normal ECG at screening
- •4. Body mass index between 18.5 to 35
排除标准
- •1. Prior history of hearing abnormalities, inner ear disorders, frequent ear infections or
- •vestibular disturbance, i.e., Meniere’s disease,
- •2. Non-insulin or insulin-dependent diabetes mellitus (documented or on HbAc1 analysis
- •with HbA1C >6.5%)
- •3. Documented inflammatory disease (e.g., including but not limited to auto immune
- •disorder, chronic obstructive pulmonary disorder, inflammatory bowel disease, arthritis)
- •4. Known or diagnosed malignancies in the past 5 years
- •5. Infectious disease (documented or on lab analysis [hepatitis B and hepatitis C virus
- •[HBV/HCV], human immunodeficiency virus [HIV], Coronavirus disease 2019
- •[COVID-19])
- •6. Received a vaccination within 14 days prior to dosing
- •7. Acute illness within 30 days prior to dosing
- •8. Hospital admission or major surgery within 30 days prior to dosing
- •9. Use of prescription medications within 2 weeks/5 half-lives of dosing, whichever is
- •10. Low-density lipoprotein cholesterol >130 mg/dL
- •11. Women who are pregnant, breast-feeding, or of child-bearing potential
- •12. History of cigarette smoking or nicotine vaping within the past year prior to screening
- •13. Vital sign parameters outside of the normal range
研究者
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