None listed
Conditions
Brief summary
This project is testing the safety and pharmacokinetics (PK, the amount of study drug in your blood) of single intravenous doses of a new drug called VGT-309. VGT-309 is a tumour targeted imaging molecule that has the potential to assist in cancer surgery. Who is it for? You may be eligible for this study if you are a healthy adult man or woman aged between 18 and 65 years old. Study details Participants will be randomised (assigned randomly, like flipping a coin) to receive a single dose of either the active study drug or placebo which will be given to you as in intravenous infusion over a period of 15 to 20 minutes. Total participation will last about 7 weeks which will include 3 days (2 nights) in the clinic during which we will need to collect blood and urine samples. It is hoped that this research will help determine the safety of VGT-309 when given to healthy men or women so that it can be tested in cancer surgery patients.
Interventions
Approximately 48 healthy men or women will be enrolled in this study in up to 6 single ascending dose cohorts comprising 8 subjects each. Subjects within each cohort will be randomised to receive either VGT-309 (6 subjects) or placebo (2 subjects). All cohorts will be started with sentinel dosing.
VGT-309 will be administered as a single intravenous infusion over 15 to 20 minutes. Normal saline will be used as a placebo control. All doses will be administered under direct observation in the P
Approximately 48 healthy men or women will be enrolled in this study in up to 6 single ascending dose cohorts comprising 8 subjects each. Subjects within each cohort will be randomised to receive either VGT-309 (6 subjects) or placebo (2 subjects). All cohorts will be started with sentinel dosing. VGT-309 will be administered as a single intravenous infusion over 15 to 20 minutes. Normal saline will be used as a placebo control. All doses will be administered under direct observation in the Phase 1 unit. The dose shall be administered per below for each cohort Cohort 1: 0.016 mg/kg Cohort 2: 0.05 mg/kg Cohort 3: 0.16 mg/kg Cohort 4: 0.32 mg/kg Cohort 5: 0.5 mg/kg Cohort 6: 0.64 mg/kg
Sponsors
Vergent Bioscience Australia, Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
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
Exclusion criteria
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
Outcome results
None listed