JPRN-jRCT2080224516已完成1 期
A Phase I Single-Ascending Dose and Multiple-Ascending Dose Study of RO6889450 in Healthy Japanese Male
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
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
- >= 20age old 至 <= 45age old（—）
- 性别
- Male
入选标准
- •(1) Healthy Japanese man who is 20 to 45 years of age at the time of informed consent.
- •(2) Body mass index (weight [kg]/[height {m}]2) of 18 to <=30 kg/m2 at screening.
- •(3) Consent by partner of childbearing potential to use a contraceptive method (hormonal contraceptives, intrauterine device, barrier method [excluding rhythm method], etc.) until 90 days after last-administration.
- •(4) Written informed consent.
排除标准
- •(1) Disorders of the central nervous system (CNS), psychiatric disorders, behavioral disturbances (e.g., cerebrovascular events, earlier or current major depression, post-traumatic stress disorder, anxiety, bipolar disorder, severe migraine, Parkinson's disease, attention deficit hyperactivity disorder).
- •(2) Positive family history of psychosis or mood disorders up to first degree relative.
- •(3) Participation in a clinical study and treatment with an IMP (including placebo) within 4 months (or 5 half-lives of the other IMP, whichever is longer) before enrollment.
- •(4) Use of prescription drugs within 2 weeks before enrollment. However, subjects will be permitted to use products that do not result in systemic exposure and would therefore have no effect even if they were used, such as topical antiseptics and eye-drops.
研究者
相似试验
已完成
不适用
Evaluation of biomarkers for JAK inhibitorKCT0005706Seoul National University Hospital8
已完成
1 期
Phase I Single- and Multiple-Ascending Dose Trial of EVX-101Mental and Behavioural DisordersDepressionISRCTN42835524Evecxia Therapeutics Inc.38
招募中
1 期
A Phase 1 Single and Multiple Ascending Dose Study to Assess the Safety and Pharmacokinetics of SZN-043, a Novel Bispecific Fusion Protein Targeting ASGR1 and ZNRF3/RNF43, in Healthy Volunteers and Subjects with Liver CirrhosisAlcoholic HepatitisInflammatory and Immune System - Other inflammatory or immune system disordersLiver CirrhosisACTRN12622000392763Surrozen Operating, Inc.40
已完成
1 期
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy ofmEphA4-FcAmyotrophic Lateral SclerosisNeurological - Other neurological disordersNeurological - Neurodegenerative diseasesACTRN12621000514808uNerve Pty. Ltd.28
已完成
1 期
A study of the safety and pharmacokinetics and pharmacodynamics of the LOXL2 inhibitor PXS-5338K in healthy male subjects given single and repeated doses.ACTRN12617001444370Pharmaxis Ltd72