ACTRN12621000592842已完成1 期
A Phase 1, Double-blind, Randomized, Placebo-controlled, First-in-human Study of Orally Administered DF-006 to Evaluate the Safety, Tolerability, and Pharmacokinetics After a Single Dose and Multiple Doses of Orally Administered DF 006 in Healthy Subjects (Part 1 and Part 2)
Zhejiang Yao Yuan Biotechnology Ltd. (Drug Farm)0 个研究点目标入组 50 人开始时间: 2021年5月18日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
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
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •Female subjects must have a negative serum pregnancy test and must not be of childbearing potential
- •Male subjects must be either surgically sterile, or incapable of fathering a child, or have a heterosexual partner partner who is not pregnant or of childbearing potential
- •Nonsmoker within last 3 months
- •BMI of 18.0 to 32.0 kg/m2
- •Subjects must be deemed healthy by the Investigator on the basis of a medical evaluation
排除标准
- •Evidence of clinically significant cardiac history
- •Personal or family history of chronic inflammatory skin disease or immune or autoimmune related disorders, diseases or syndromes
- •History or current evidence of use of amphetamines, barbiturates, narcotic or other drugs of abuse/recreational drug use, except under physician supervision
- •Excessive use of alcohol and unwilling to abstain from alcohol use for 48 hours prior to start of dosing through end of study follow-up
- •Subjects with current hepatitis A, B, C, D, E, HIV, infection or acute infection such as SARS-CoV-2 (COVID-19)
- •Subjects with kidney disease or significant abnormal vital signs
研究者
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