ACTRN12624000137594尚未招募1 期
A phase 1, Randomised, placebo-controlled, single-blind, single-ascending dose study, to determine the safety and tolerability of intravenous Gemini in healthy volunteers.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 40
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
- •Healthy volunteers will be included in the study if they satisfy all the following criteria:
- •1.Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
- •2.Adult volunteers, 18 to 55 years of age, inclusive, at Screening.
- •3.Is medically healthy (in the opinion of the PI or identified Sub-I(s)), as determined by pre-study medical history, and without clinically significant abnormalities including:
- •Physical examination without any clinically relevant findings
- •Systolic blood pressure in the range of 90 to 160 mmHg and diastolic blood pressure in the range of 50 to 95 mmHg after 5 minutes in a sitting, supine or semi-supine position
- •Heart rate (HR) in the range of 45 to 100 bpm after 5 minutes rest in a sitting, supine or semi-supine position
- •Body temperature (tympanic), between 35.5°C and 37.7°C
- •Electrocardiogram (ECG) without clinically significant abnormalities including QT interval corrected for Fredericia (QTcF) <450 msec for male subjects and <470 msec for female subjects
- •No clinically significant findings in serum chemistry, haematology and urinalysis tests
- •4.Non-smoker, non-tobacco user and non-nicotine product user or a former smoker/user (has not smoked, vaped or used tobacco/nicotine products in the 6 months prior to dosing.
- •5.Participant must have a Body Mass Index (BMI) greater than or equal to 18.0 kg/m2 and less than or equal to 32.0 kg/m2 at screening.
- •6.Female participants must be of non-childbearing potential or using a medically acceptable contraceptive regimen from screening until 30 days post dose.
- •7.Male participants must be surgically sterile or using a medically acceptable contraceptive regimen from screening until 90 days post dose.
- •8.Participant must be willing and able to comply with the study schedule, restrictions, and requirements.
排除标准
- •Volunteers will be excluded from the study if there is evidence of any of the following:
- •1.Known hypersensitivity to any of the study drug ingredients.
- •2.Concomitant disease, disability, or condition which may interfere with the conduct of the study, or which would, in the opinion of the PI or identified Sub-I(s), pose an unacceptable risk to the participants in this study, including, but not limited to alcohol dependency or abuse (in the past 2 years defined as >21 units of alcohol per week for males and >14 units of alcohol per week for females. Where 1 unit = 360mL of beer, 150mL of wine, or 45mL of spirits), drug dependency or abuse (in the past 2 years), or previously diagnosed psychiatric disease (stable depression is acceptable).
- •3.Positive drugs of abuse test, cotinine test or alcohol breath test results at the screening and/or Day -1.
- •4.Do not have suitable veins for multiple venipunctures/cannulations as assessed by the PI or identified Sub-I(s) at screening.
- •5.Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance of <80 mL/min using the Cockcroft-Gault equation at screening and Day -1.
- •6.Abnormal liver function tests as indicated by alanine aminotransferase (ALT) > 1.5x upper limit of normal (ULN), aspartate aminotransferase (AST) > 1.5 x ULN or total bilirubin >1.5 x ULN at screening and Day -1.
- •7.Verbal history of risk factors or symptoms for SARS-CoV-2 at Screening and Day -1.
- •8.Have hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV-1 or HIV-2) at screening.
- •9.Verbal history of being immunocompromised due to disease or medication (e.g., cancer immunosuppressive therapy), hypertension, coronary artery disease with history of stent or graft, heart failure NYHA class 2 or greater, or diabetes at screening.
- •10.Used any prescription medications within 14 days, or over-the-counter medications within 7 days of Day -1, with the exception of contraceptives or hormone replacement therapy for female participants and occasional paracetamol use (at the discretion of the PI or identified Sub-I(s)).
- •11.Used vitamins, dietary or herbal supplement, or nutritional supplement within 7 days of Day -1.
- •12.Administration of systemic antibiotics or antivirals within 7 days of Day -1 (excluding topical/external use of antibiotics).
- •13.History of surgery or hospitalization within 3 months of Day -1, or surgery planned during the study.
- •14.Pregnant or breast-feeding women.
- •15.Participant has received any immunoglobulins and/or blood products within 3 months of Day -1.
- •16.Participant has donated blood or plasma within 30 days prior to screening or had a loss of whole blood of more than 500ml within the 30 days prior to screening.
- •17.Participant has had acute respiratory illness within 30 days of Day -1.
- •18.Participant has received treatment with any investigational product in any clinical study within 30 days of Day -1 or five half-lives, whichever is longer.
- •19.Participant has received a vaccination within 30 days of Day -1.
- •20.Participant is unwilling or unable to comply with the study protocol requirements.
研究者
相似试验
已完成
1 期
A Phase 1 Randomized, Placebo-Controlled, Single & Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of GLY-200 in Healthy Adult SubjectsMetabolic and Endocrine - DiabetesType 2 DiabetesACTRN12621000800820Glyscend Pty Ltd64
已完成
1 期
Safety and tolerability of single and multiple-ascending doses of the study drug ACP-014 in Healthy volunteers.HypoparathyroidismACTRN12617001375347Ascendis Pharma Bone Diseases A/S186
已完成
不适用
A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL919 in Healthy ParticipantsAlzheimers10012303Alzheimer's DiseaseNL-OMON51440Denali Therapeutics Inc.80
已完成
1 期
Study of ZYN002 (cannabidiol gel) in 40 Healthy VolunteersMental Health - Other mental health disordersNeurological - EpilepsyMusculoskeletal - OsteoarthritisHuman Genetics and Inherited Disorders - Other human genetics and inherited disordersEpilepsyFragile X SyndromeOsteoarthritisACTRN12618000183280Zynerba Pharmaceuticals Pty. Ltd.40
进行中（未招募）
1 期
BIIB115 in Healthy Volunteers and Pediatric SMA Patients Previously Treated with ZolgensmaSpinal muscular atrophyMedDRA version: 20.1Level: PTClassification code 10041582Term: Spinal muscular atrophySystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2022-000956-12-PLBiogen Idec Research Limited62