ACTRN12620000948998已完成1 期
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study in Healthy Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of VGT-309
Vergent Bioscience Australia, Pty Ltd0 个研究点目标入组 46 人开始时间: 2020年9月22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
- 46
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 55 Years（—）
- 性别
- All
入选标准
- •1. Be willing and able to sign the informed consent and comply with study procedures.
- •2. Be between the ages of 18 and 55, inclusive
- •3. Be male or female and meet the following conditions:
- •a. Female participants must be of non-childbearing potential, or,
- •b. If of childbearing potential be non-pregnant or lactating and agree to use highly effective contraception.
- •c. Male participants, if not surgically sterilized, and if engaging in sexual intercourse with a female partner of childbearing potential, must be willing to use highly effective contraception.
- •d. Highly effective contraception involves the use of a condom for the male, plus one of the following for the female:
- •- Oral, injectable, implantable, intravaginal, or transdermal hormonal contraceptives, or
- •- Intrauterine device or intrauterine hormone-releasing system
- •NOTE: Participants that are abstinent from heterosexual intercourse as part of their usual and preferred lifestyle are not required to use contraception
- •4. Be considered healthy by the Investigator, based on a detailed medical history, full physical examination, clinical laboratory tests, 12-lead ECG and vital signs
- •5. Be a nonsmoker, defined as not having smoked, vaped or used any form of tobacco for more than 6 months before screening. NOTE: subjects who smoke occasionally (no more than 2 cigarettes per week) are allowed provided their cotinine test is negative at screening and they abstain from smoking during the study.
- •6. Be willing to stop all prescription or over-the-counter medications from 7 days prior to admission to Day 7 of the study.
- •7. Not have participated in a clinical trial within the last 30 days
排除标准
- •1. A positive blood screen for human immunodeficiency virus (HIV) antibodies, hepatitis B surface or core antigen (HBsAg, HBcAg), or hepatitis C antigen
- •2. A hospital admission or major surgery within 30 days prior to screening
- •3. A pre-planned hospital admission or surgery scheduled within 30 days post-dosing
- •4. A known allergy or reaction to ICG or other radiographic contrast agents
- •5. A history of prescription drug abuse or illicit drug use within 6 months prior to screening
- •6. A history of alcohol abuse within 6 months prior to screening as determined by the PI
- •7. A positive screen for alcohol or drugs of abuse including cotinine
- •8. Donated more than one unit of blood or blood products during the 3 months prior to screening
- •9. Any other co-morbidity or habit that the Investigator believes will interfere with their ability to comply with and complete the study
- •10. A history of clinically significant hypotension
- •11. Abnormal systolic or diastolic blood pressure or heart rate at screening or Day -1
- •12. Congenital long QT or QTcF>450 ms (males) or >470 ms (females) by history or at screening
- •13. AST, ALT or bilirubin > upper limit of normal at screening
- •14. Serum creatinine > upper limit of normal at screening
研究者
相似试验
已完成
不适用
A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of N-Rephasin® SAL200 in Healthy Male Volunteers.Diseases of the blood and blood -forming organs and certain disorders involving the immune mechanismKCT0000968iNtRON Biotechnology36
进行中（未招募）
1 期
A Study of JNJ-75105186 in Healthy Japanese and Chinese ParticipantsHealthyJPRN-jRCT2071210082akano Masayoshi32
已完成
不适用
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of REC-3964 in Healthy SubjectsNL-OMON53684Recursion Pharmaceuticals, Inc.106
进行中（未招募）
1 期
Safety, tolerability, pharmacokinetics and pharmacodynamics of CBP-201 in healthy volunteersAtopic DermatitisACTRN12618000756224Connect Biopharma Australia Pty Ltd40
进行中（未招募）
1 期
A Randomized, Double-blind, Placebo-controlled, Single-center, Single and Multiple Oral Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral BF2.649 (pitolisant hydrochloride) in Healthy Japanese Adult SubjectsJPRN-jRCT2071210104Takuma Yonemura28