ISRCTN16476560进行中（未招募）1 期
A two-part phase 1 study to assess the safety, tolerability and pharmacokinetics of UNI-494 with an optional third-part to assess the relative bioavailability compared to nicorandil in healthy male and female subjects
nicycive Therapeutics Inc.0 个研究点目标入组 64 人开始时间: 2022年11月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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
- 性别
- All
入选标准
- •1. Must provide written informed consent
- •2. Must be willing and able to communicate and participate in the whole study
- •3. Subjects must be willing and able to swallow multiple capsules
- •4. Aged 18 to 55 years inclusive at the time of signing informed consent
- •5. Must agree to adhere to the contraception requirements defined in the clinical protocol
- •6. Healthy males or healthy females of non-childbearing potential
- •7. Body mass index (BMI) of 18.0 to 32.0 kg/m² as measured at screening
- •8. Weight =50 kg at screening
- •9. Must have a normal blood pressure defined as a systolic BP between 100 and 140 mmHg, diastolic BP between 40 and 90mmHg after 5 mins supine
- •10. No evidence of postural hypotension (defined as a dizziness / light headedness or a drop is systolic BP >20mmHg or drop in diastolic BP >10 mmHg when assessed 3 minutes after standing
排除标准
- •1. Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
- •2. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
- •3. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
- •4. Subjects with a history of cholecystectomy or gall stones
- •5. Subjects with any past history of gastrointestinal ulceration (e.g. peptic ulcer disease), gastrointestinal haemorrhage, diverticular disease or recent (within 6 months) symptoms of dyspepsia lasting 2 weeks or more
- •6. Recurrent and recent history of simple faints, vasovagal presyncope/syncope or blackouts
- •7. Subjects with glucose-6-phosphate dehydrogenase deficiency
- •8. Subjects with a history of conjunctival or corneal ulceration within the past 12 months.
- •9. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening
- •10. Evidence of current SARS-CoV-2 infection
- •11. Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator. Subjects with Gilbert’s Syndrome are not allowed
- •12. Subjects with elevated potassium above the upper limit of the normal reference range
- •13. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results
- •14. Females of childbearing potential including those who are pregnant or lactating (all female subjects must have a negative highly sensitive urine [or serum] pregnancy test). A woman is considered of childbearing potential unless she is permanently sterile (hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) or is postmenopausal (had no menses for 12 months without an alternative medical cause and a serum follicle stimulating hormone [FSH] concentration =40 IU/L)
- •15. Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1, or less than 5 elimination half-lives prior to Day 1, whichever is longer
- •16. Subjects who have previously been administered IMP in this study. Subjects who have taken part in Part 1 are not permitted to take part in Parts 2 and 3. Subjects who have taken part in Part 2 are not permitted to take part in Part 3
- •17. Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood
- •18. Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4 g of paracetamol per day or established HRT) in the 14 days before study medication administration. COVID-19 vaccines are accepted concomitant medications. Exceptions may apply, as determined by the investigator, if each of the following criteria are met: medication with a short half-life if the washout is such that no PD activity is expected by the time of dosing with IMP; and if the use of medication does not jeopardise the safety of the trial subject; and if the use of medication is not considered to interfere with the objectives of the study
- •19. Subjects who are using PDE5 inhibitors
- •20. History of any drug or alcohol abuse in the past 2 years
- •21. Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units =
研究者
相似试验
招募中
1 期
Safety, Tolerability, Pharmacokinetics (including Food Effect) of Single Ascending Doses of SAR441121 in healthy male subjects.ACTRN12618001783213sanofi-aventis australia ptd ltd62
已完成
不适用
A phase 1a/1b/2 study to assess the safety, tolerability and pharmacokinetics of OTL78, a PSMA-targeted fluorescent agent, for the intraoperative imaging of prostate cancerProstate cancerNL-OMON49366OnTarget Laboratories39
已完成
1 期
Testing safety and efficacy of a live bacterial therapy for the treatment of Helicobacter pylori infectioInfection - Other infectious diseasesOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colonHelicobacter pylori infectionACTRN12620000923965Servatus Ltd28
进行中（未招募）
1 期
Study for intra-operative imaging of prostate cancer using OTL78Prostate cancerEUCTR2019-002393-31-NLOnTarget Laboratories24
进行中（未招募）
1 期
A Study of MK-1088 as monotherapy and in combination with pembrolizumab in patients with advanced solid tumorsCTIS2022-502288-40-00Merck Sharp & Dohme LLC95