NL-OMON56052招募中不适用
A Randomised, Double-Blind, Placebo-Controlled, Single- and Multiple-, Ascending-Dose Study of the Safety, Tolerability, and Pharmacokinetics and Pharmacodynamics of VRG50635 and Food Effect in Healthy Volunteers (Phase 1a) - SAD MAD of VRG50635 in HV
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Inclusion criteria - Parts 1 and 2
- •1. Healthy male or female between 18 to 65 years of age at screening
- •(inclusive).
- •4. For male and female subjects of childbearing potential: Subjects and their
- •spouse/partners who are of childbearing potential must use highly effective
- •contraception when engaging in sexual activity consisting of 2 forms of birth
- •control (1 of which must be a barrier method such as latex or polyurethane
- •condoms) starting at screening and continue throughout the clinical study
- •period, and for 90 days after the final study drug administration.
- •5. For males: Subject must not donate sperm starting at screening and
- •throughout the clinical study period, and for 90 days after the final study
- •drug administration.
排除标准
- •Exclusion criteria - Parts 1 and 2
- •1. History of clinically significant hematological, renal, neurologic,
- •pancreatic, gastrointestinal, hepatic, cardiovascular, psychological,
- •pulmonary, metabolic, endocrine, immunological, allergic disease, or other
- •major disorders.
- •2. Current significant medical or psychiatric condition.
- •4. Evidence of clinically significant hepatic or renal impairment in the
- •opinion of the investigator, including alanine aminotransferase (ALT) or
- •aspartate aminotransferase (AST) >1.5 the upper limit of normal (ULN) or
- •bilirubin > 1.5 ULN. Patients with Gilbert syndrome without evidence of hepatic
- •impairment may be enrolled.
- •14. Poor peripheral venous access.
- •21. A lifetime history of suicidal behavior or suicidal ideation as determined
- •by a positive response (**Yes**) to either question 4 or question 5 of the
- •C-SSRS at screening.
- •26. For part 2 only: Subjects not eligible for lumbar puncture
- •(anti-coagulation, anti-aggregation or blood coagulation pathologies, recent
- •spine surgery, acquired or congenital spine malformation, clinical signs of
- •intracranial hypertension, cutaneous infection at the punction site)
研究者
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