A phase 1, Randomised, placebo-controlled, single-blind, single-ascending dose study, to determine the safety and tolerability of intravenous Gemini in healthy volunteers.
- Conditions
- Post-surgical infectionSurgery - Other surgery
- Registration Number
- ACTRN12624000137594
- Lead Sponsor
- Revelation Biosciences Sub Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 40
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method