A phase 1, Randomised, placebo-controlled, single-blind, single-ascending dose study, to determine the safety and tolerability of intravenous Gemini in healthy volunteers.

Exclusion Criteria21

• Volunteers will be excluded from the study if there is evidence of any of the following:
• Known hypersensitivity to any of the study drug ingredients.
• 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).
• Positive drugs of abuse test, cotinine test or alcohol breath test results at the screening and/or Day -1.
• Do not have suitable veins for multiple venipunctures/cannulations as assessed by the PI or identified Sub-I(s) at screening.
• 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.
• 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.
• Verbal history of risk factors or symptoms for SARS-CoV-2 at Screening and Day -1.
• Have hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV-1 or HIV-2) at screening.
• 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.
• 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)).
• Used vitamins, dietary or herbal supplement, or nutritional supplement within 7 days of Day -1.
• Administration of systemic antibiotics or antivirals within 7 days of Day -1 (excluding topical/external use of antibiotics).
• History of surgery or hospitalization within 3 months of Day -1, or surgery planned during the study.
• Pregnant or breast-feeding women.
• Participant has received any immunoglobulins and/or blood products within 3 months of Day -1.
• 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.
• Participant has had acute respiratory illness within 30 days of Day -1.
• 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.
• Participant has received a vaccination within 30 days of Day -1.
• Participant is unwilling or unable to comply with the study protocol requirements.