ACTRN12624000775516尚未招募1 期
A Phase 1, Randomized, Blinded, Placebo-controlled, Single Ascending Dose, First-in-human Study of the Safety, Tolerability, and Pharmacokinetics of APG990 in Healthy Participants
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 40
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 65 Years（—）
- 性别
- All
入选标准
- •1. Healthy men and women, in the opinion of the Investigator and as determined by physical examination, laboratory screening tests, and medical history
- •2. 18 to 65 years of age (inclusive) with a body mass index of 18.0 to 32.0 kilogram per square meter (kg/m^2) (inclusive), weight less than (<) 120 kilogram (kg)
- •3. Willing to use a highly effective method of contraception from 30 days prior to admission through 30 days after end of study (EOS) or 5 half-lives after the last administration of study drug, whichever is longer
- •4. Willing to abstain from alcohol and tobacco use for 48 hours prior to admission to the CRU (Day -1) and during inpatient period, and any illicit drug abuse for greater than or equal to (>=) 48 hours prior to admission to the CRU (Day -1)
排除标准
- •1. Evidence of clinically significant abnormalities or disease
- •2. History of any of the following:
- •a. Clinically significant opportunistic infection (eg, invasive candidiasis or pneumocystis pneumonia) within 5 years prior to Screening
- •b. Serious local infection (eg, cellulitis) or systemic infection (eg, septicemia) within 3 months prior to Screening
- •3. Known history of illicit drug abuse, harmful alcohol use (defined as an average of >10 standard drinks per week or at the Investigator’s discretion) or alcoholism, and/or heavy tobacco use (defined as >=5 cigarettes per day or equivalent) within 2 years prior to Screening; positive screen for drugs of abuse (except tetrahydrocannabinol [THC]), or alcohol breath test at Screening or admission to the CRU (or at the Investigator’s discretion), and participants must abstain from cigarette smoking for the duration of their stay in the CRU. Participants may be rescreened for drugs of abuse or alcohol breath test at the Investigator’s discretion
- •4. History of severe allergic reactions or hypersensitivity (ie, anaphylaxis)
- •5. If female, nursing, lactating, pregnant, or plans to become pregnant within 30 days of EOS or 5 half-lives (whichever is longer) of last study drug administration
- •6. Use of any investigational drug therapy within 30 days or 5 half-lives (whichever is longer) prior to study drug dosing through 5 half-lives after the last dose of study drug
- •7. Use of any depot injection or implant for 3 months prior to dosing
研究者
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