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Trial registered on ANZCTR


Registration number
ACTRN12620000948998
Ethics application status
Approved
Date submitted
2/07/2020
Date registered
22/09/2020
Date last updated
22/09/2020
Date data sharing statement initially provided
22/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of VGT-309 in Healthy Subjects
Scientific title
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study in Healthy Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of VGT-309
Secondary ID [1] 301634 0
Protocol VGT-309-1-2020
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 318046 0
Condition category
Condition code
Cancer 316077 316077 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Approximately 32 healthy men or women will be enrolled in this study in up to 4 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
Intervention code [1] 317942 0
Treatment: Other
Comparator / control treatment
The placebo will be normal saline.

VGT-309 and the placebo control solution will be of two different colors. Masking techniques will be used to protect the blind in this study.
Control group
Placebo

Outcomes
Primary outcome [1] 324276 0
To evaluate the safety of VGT-309 when compared with placebo in healthy volunteers through the assessment of:treatment-emergent adverse events assessed through regular solicitation of volunteers and review of physical examination data, vital sign data including blood pressure measured using a digital blood pressure monitor, heart rate measured as beats per minute, temperature and respiratory rate measured as breaths per minute, ECG data and clinical laboratory assessments of blood and urine: hematology (standard panel), coagulation (INR only), chemistry (standard panel including LFTs and amylase)


Timepoint [1] 324276 0
Treatment-emergent adverse events will be collected from the time of dosing on Day 1 through the Day 30 final safety follow-up visit
Physical examinations will be conducted at screening, on Day -1, Day 2, Day 7 and Day 30
Clinical laboratory assessments of blood and urine will be collected at screening, on Day -1, post dose on Day 1, Day 2, Day 7, and Day 30
ECGs will be collected at screening, on Day -1, pre-dose on Day 1, immediately post dose and at 1, 2, 3, 4, 8, 12, 18 and 24 hours post dose, and on Day 7 and Day 30.
Vital signs will be collected at screening, on Day -1, pre-dose on Day 1, immediately after dosing and at 15 minutes, 30 minutes, 1 hour, 2 hours, 6 hours, 12 hours and 24 hours post-dose, and on Day 7 and Day 30
Secondary outcome [1] 384236 0
To characterise the pharmacokinetic profile of VGT-309 in healthy volunteers. Pharmacokinetic parameters include maximal concentration (Cmax), time for maximal concentration (Tmax), area under the concentration–time curve (AUC, 0–10 h), half-life (t1/2), elimination rate constant (Ke), and total body clearance (CL).
Timepoint [1] 384236 0
Blood samples for PK assessments will be taken at the following times: Up to 2 hours before dosing and 10, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 12, 18, 24 and 48 hours after dosing. (14 blood draws)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation via an electronic data capture system
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Safety
Statistical methods / analysis
This is an early development study, and therefore no statistical considerations were involved in the sample size determination. It is expected that the sample size of 32 subjects in 4 cohorts of 8 subjects each (6 on active treatment and 2 on placebo) should be adequate for evaluation of safety, tolerability and pharmacokinetics in this single ascending dose study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 30652 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 306071 0
Commercial sector/Industry
Name [1] 306071 0
Vergent Bioscience Australia, Pty Ltd
Address [1] 306071 0
c/o Case Governance Pty Ltd
Level 13
41 Exhibition Street
Melbourne, VIC, 3000
Country [1] 306071 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Vergent Bioscience Australia, Pty Ltd
Address
c/o Case Governance Pty Ltd
Level 13
41 Exhibition Street
Melbourne, VIC, 3000
Country
Australia
Secondary sponsor category [1] 306532 0
None
Name [1] 306532 0
Address [1] 306532 0
Country [1] 306532 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306293 0
Alfred Hospital Human Research Ethics Committee
Ethics committee address [1] 306293 0
55 Commercial road, Melbourne , Vic - 3004
Ethics committee country [1] 306293 0
Australia
Date submitted for ethics approval [1] 306293 0
27/07/2020
Approval date [1] 306293 0
01/09/2020
Ethics approval number [1] 306293 0
462/20 (HREC/67288/Alfred-2020)

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103390 0
Dr Jason Lickliter
Address 103390 0
Centre for Clinical Studies, Nucleus Network Ltd
5th Floor, Burnet Building, AMREP Precinct,
89 Commercial Rd, Melbourne, VIC, 3004
Country 103390 0
Australia
Phone 103390 0
+61 3 9076 8960
Fax 103390 0
Email 103390 0
j.lickliter@nucleusnetwork.com.au
Contact person for public queries
Name 103391 0
Ms Jessica Faggian
Address 103391 0
Centre for Clinical Studies, Nucleus Network Ltd
5th Floor, Burnet Building, AMREP Precinct,
89 Commercial Rd, Melbourne, VIC, 3004
Country 103391 0
Australia
Phone 103391 0
+61 3 9076 8958
Fax 103391 0
Email 103391 0
J.Faggian@nucleusnetwork.com.au
Contact person for scientific queries
Name 103392 0
Dr Jason Lickliter
Address 103392 0
Centre for Clinical Studies, Nucleus Network Ltd
5th Floor, Burnet Building, AMREP Precinct,
89 Commercial Rd, Melbourne, VIC, 3004
Country 103392 0
Australia
Phone 103392 0
+61 3 9076 8960
Fax 103392 0
Email 103392 0
j.lickliter@nucleusnetwork.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data will not be made available for this study. All subject data obtained will be de-identified and captured in a final study report that will not identify individual participants.
What supporting documents are/will be available?
No other documents available
Summary results
No Results