NL-OMON27747招募中不适用
A study to assess the safety, tolerability, and pharmacokinetics of FM101 after single and multiple ascending dose administration to healthy subjects.
Future Medicine Ltd.0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 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
入排标准
入选标准
- •1.Gender:male or female
- •2.Age:18 - 50 years, inclusive, at screening
- •3.Body mass index (BMI):18.0 – 32.0 kg/m2 (inclusive)
- •4.Weight:= 50 kg
- •5.Status:healthy subjects
- •6.At screening, females must be non-pregnant and non-lactating, or of non childbearing potential (either surgically sterilized or physiologically incapable of becoming pregnant, or at least 1 year post menopausal [amenorrhea duration of 12 consecutive months); non-pregnancy will be confirmed for all females by a serum pregnancy test conducted at screening, and a urine pregnancy test at each admission and at follow-up.
- •7.Female subjects of child-bearing potential, with a fertile male sexual partner, must agree to use adequate contraception from screening until 90 days after the follow up visit. Adequate contraception is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm or cervical cap, or a condom. Also, total abstinence, in accordance with the lifestyle of the subject, is acceptable.
- •8.Male subjects, if not surgically sterilized, must agree to use adequate contraception and not donate sperm from first admission to the clinical research center until 90 days after the follow-up visit. Adequate contraception for the male subject (and his female partner) is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm or cervical cap, or a condom. Also, total abstinence, in accordance with the lifestyle of the subject is acceptable.
- •9.All prescribed medication must have been stopped at least 14 days prior to (each) admission to the clinical research center. An exception is made for hormonal contraceptives, which may be used throughout the study.
- •10.All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (eg, St. John’s Wort) must have been stopped at least 7 days prior to (each) admission to the clinical research center. An exception is made for paracetamol, which is allowed up to admission to the clinical research center.
- •11.Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks), grapefruit (juice), and tobacco products from 48 hours prior to (each) admission to the clinical research center.
- •12.Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG, and vital signs, as judged by the Investigator.
- •13.Willing and able to sign the ICF.
排除标准
- •1.Employee of CRO or the Sponsor.
- •2.History of relevant drug and/or food allergies.
- •3.Using tobacco products within 60 days prior to (the first) drug administration.
- •4.History of alcohol abuse or drug addiction (including soft drugs like cannabis products).
- •5.Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, gamma hydroxybutyric acid [GHB], tricyclic antidepressants, and alcohol) at screening and (each) admission to the clinical research center.
- •6.Average intake of more than 24 units of alcohol per week (1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits).
- •7.Positive screen for hepatitis B surface antigen (HBsAg), anti hepatitis C virus (HCV) antibodies, or anti human immunodeficiency virus (HIV) 1 and 2 antibodies.
- •8.Participation in a drug study within 60 days prior to (the first) drug administration in the current study. Participation in more than 3 other drug studies (for male subjects) / more than 2 other drug studies (for female subjects) in the 10 months prior to (the first) drug administration in the current study.
- •9.Donation or loss of more than 100 mL of blood within 60 days prior to (the first) drug administration. Donation or loss of more than 1.5 liters of blood (for male subjects) / more than 1.0 liters of blood (for female subjects) in the 10 months prior to (the first) drug administration in the current study.
- •10.Significant and/or acute illness within 5 days prior to (the first) drug administration that may impact safety assessments, in the opinion of the Investigator.
- •11.Non-willingness to consume the high-fat breakfast (Part B only).
- •12.Unsuitable veins for infusion or blood sampling.
研究者
相似试验
已完成
不适用
A study to assess the safety, tolerability and pharmacokinetic properties of CEP-37248, a drug for the treatment of autoimmune inflammatory diseases, in healthy men.Autoimmune disease10003816NL-OMON40424TEVA Pharma93
已完成
1 期
A programme to develop a skin patch containing two medicines (physostigmine and hyoscine), Study 6: Assessment of blood levels of the two medicines and any associated symptoms in healthy female participants.ISRCTN15358284Dstl36
已完成
不适用
A study to investigate the safety, tolerability and absorption and elimination of CCX507-B, a new drug for the treatment of patients with inflammatory bowel diseases, in healthy male and female subjects.Crohn's disease.Inflammatory bowel diseases10017969NL-OMON40895ChemoCentryx, Inc.30
已完成
不适用
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of Donepezil with Glycopyrrolate or Trospium in Elderly Volunteers1004225810012272Alzheimer's diseasedementiaNL-OMON45462Axovant Sciences Ltd.75
已完成
1 期
A study comparing extended release and immediate release formulations of EQ121 following single doses in healthy adult volunteers- Part AInflammatory and Immune System - Rheumatoid arthritisRheumatoid ArthritisACTRN12622000307707EQRx International, Inc.32