ACTRN12614000479606已完成1 期
A Phase I Randomised, Double-Blind, Placebo-Controlled Dose Escalating Study of the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of Oral NP202 in Adult Healthy Volunteers
euProtect Pty Ltd0 个研究点目标入组 64 人开始时间: 2014年5月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 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
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- Male
入选标准
- •Subjects who;
- •- Provide written informed consent.
- •- Are male aged 18 to 45 years old inclusive at the time of consent.
- •- Have a body mass index (BMI) <30 Kg/m2.
- •- Have adequate venous access to allow collection of multiple blood samples during the study
排除标准
- •Subjects who:
- •- Have received blood products within 1 month prior to Screening.
- •- Have received any investigational research agent within 30 days or 5 half-lives (whichever is longer) prior to the first dose of Investigational Product.
- •- Have received an investigational vaccine within 6 months, a live attenuated vaccine within 60 days or a registered vaccine within 30 days prior to the first dose of the Investigational Product.
- •- Have a history of severe or life-threatening drug allergy and/or known drug hypersensitivity.
- •- Have a bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with blood draws.
- •- Have a current malignancy or previous malignancy that is likely to recur during the period of the study (with the exception of a past history of basal or squamous cell carcinomas).
- •- Have a psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder; disorder requiring lithium; or within five years prior to Screening, a history of suicide plan
- •- Have any clinically significant abnormality at Screening determined by medical history, physical examination, blood chemistry, haematology, urinalysis and a 12-lead electrocardiogram (ECG)
- •- Have positive Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C Screening test results
- •- Have a history of or current clinically significant gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine, oncological, immunodeficiency, neurological, metabolic, haematological or autoimmune disorder
- •- Have clinical signs of active infection and/or a temperature of >38.0 degrees C at the time of screening.
- •- Have evidence of drug or alcohol abuse, or positive urine screen for drugs of abuse.
研究者
相似试验
已完成
1 期
A Phase 1 Randomised, Double-Blind, Placebo-Controlled, Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of Orally Administered PRN1008Healthy VolunteersInflammatory and Immune System - Autoimmune diseasesACTRN12614000359639Clinical Network Services (CNS) Pty Ltd.108
招募中
1 期
An interventional study to evaluate the safety and immune response of a vaccine against Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2, the virus that causes COVID-19 infection) when given to healthy adult participants.COVID-19Infection - Other infectious diseasesACTRN12620000674932niversity of Queensland120
尚未招募
不适用
A Safety and Tolerability study of the drug UE2343, a potential treatment for Alzheimer's Disease and Mild Cognitive Impairment.DementiaAlzheimer's diseaseACTRN12615000117516Actinogen Medical24
已完成
1 期
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of of PRTX007 in Healthy AdultsCOVID-19Infection - Other infectious diseasesRespiratory - Other respiratory disorders / diseasesACTRN12621000468820Primmune Therapeutics Australia Pty Ltd112
进行中（未招募）
不适用
A Phase I Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Study the Safety, Efficacy, and Mechanism of Action of Sitagliptin and Pioglitazone in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet and Exercise - NDType 2 diabetes mellitusMedDRA version: 9.1Level: LLTClassification code 10012613Term: Diabetes mellitus non-insulin-dependentEUCTR2007-001771-11-ITMERCK SHARP DOHME208