ACTRN12619001609145已完成1 期
A Phase 1, Randomized, Placebo-controlled Safety, Tolerability and Pharmacokinetic Study of Single Ascending Doses of LMR-123 in Healthy Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
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 49 Years（—）
- 性别
- All
入选标准
- •1. Male or female healthy subjects, aged 18 to 49 years inclusive;
- •2. Body mass index of >19.0 kg/m2 to <29.0 kg/m2 at screening;
- •3. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
- •Not of childbearing potential, defined as surgically sterile or postmenopausal.
- •Of childbearing potential and agrees to use a highly effective method of contraception consistently during the treatment period and for at least 60 days after the last dose of investigational product;
- •4. A male subject with a female partner of childbearing potential is eligible to participate if he agrees to use acceptable contraception during the treatment period and for at least 60 days after the last dose of investigational product All male subjects must refrain from donating sperm during the treatment period and for at least 60 days after the last dose of investigational product ;
- •5. Females of childbearing potential must have a negative pregnancy test at screening (serum) and Day 1 (urine)
- •6. The subject must voluntarily provide written informed consent prior to any study procedures being performed and is willing and able to comply with procedures required in this protocol.
- •Additional Inclusion Criteria for Cohort 7 Only:
- •7. Be of East Asian/South East Asian descent: Both parents must be from China, Hong Kong, Japan, Macau, Mongolia, North Korea, South Korea, Taiwan, Indochinese Peninsula comprising of Cambodia, Laos, Myanmar, Peninsula Malaysai, Thailand, Vietnam, Malay Archipelago/Nusantara comprising of the Andaman and Nicobar
- •Islands (India), Brunei, East Malaysia, East Timor, Indonesia (except Western New Guinea), Phillipines and Singapore.
排除标准
- •1. History or evidence of a clinically significant disorder.
- •2. History significant ophthalmic diseases including but not limited to vitreous opacities, glaucoma, cataract, ophthalmic infection and ophthalmic tumor;
- •3. History or presence of conditions known to interfere with the distribution, metabolism, or excretion of drugs;
- •4. Unwillingness to abstain from alcohol from 48 hours prior to investigational product administration.
- •5. A positive urine drug screen or alcohol breath test at screening;
- •6. Subjects smokes more than 10 cigarettes per day within 3 months of screening
- •7. History of surgery or major trauma within 12 weeks of screening, or surgery planned during the study;
- •8. History of significant neurological diseases, including stroke, transient ischemic attacks, seizures, and vascular malformations;
- •9. Positive screen for human immunodeficiency virus, hepatitis B virus surface antigen or hepatitis C virus antibody;
- •10. Treatment with any investigational product within 30 days or 5 half-lives
- •11. Use of prescription or over the counter medications within 14 days of investigational product administration and during the study, with the exception of contraceptive medications, paracetamol and vitamins;
- •12. History of cancer,
- •13. History of allergic reactions
- •14. Subject has a positive test for tuberculosis (TB) during screening or a known history of active or latent TB
- •15. Donation or collection of more than or equal to 400 mL of blood for any other purpose within 12 weeks more than or equal to 200 mL within 4 weeks, or donation of blood by apheresis within 2 weeks of the planned first dose.
- •16. Subject does not agree to avoid food or beverages likely to influence liver metabolism 7 days prior to the first dose of the investigational product until the end of study visit;
- •17. Subject does not agree to refrain from consuming caffeinated beverages from 48 hours before check-in on Day -1 until completion of the confinement period.
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