ANZCTR - Registration

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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

17/03/2023

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]

Protocol VGT-309-1-2020

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cancer

Condition category

Condition code

Cancer

Any cancer

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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

Intervention code [1]

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]

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]

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]

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]

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

Sex

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 48 subjects in 6 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

Completed

Date of first participant enrolment

Anticipated

2/11/2020

Actual

23/10/2020

Date of last participant enrolment

Anticipated

15/12/2022

Actual

13/01/2023

Date of last data collection

Anticipated

24/01/2023

Actual

8/02/2023

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Nucleus Network - Melbourne

Recruitment postcode(s) [1]

3004 - Melbourne

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Vergent Bioscience Australia, Pty Ltd

Address [1]

c/o Case Governance Pty Ltd
Level 13
41 Exhibition Street
Melbourne, VIC, 3000

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Hospital Human Research Ethics Committee

Ethics committee address [1]

55 Commercial road, Melbourne , Vic - 3004

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/07/2020

Approval date [1]

01/09/2020

Ethics approval number [1]

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

Dr Jason Lickliter

Address

Centre for Clinical Studies, Nucleus Network Ltd
5th Floor, Burnet Building, AMREP Precinct,
89 Commercial Rd, Melbourne, VIC, 3004

Country

Australia

Phone

+61 3 9076 8960

Fax

j.lickliter@nucleusnetwork.com.au

Contact person for public queries

Name

Jessica Faggian

Address

Centre for Clinical Studies, Nucleus Network Ltd
5th Floor, Burnet Building, AMREP Precinct,
89 Commercial Rd, Melbourne, VIC, 3004

Country

Australia

Phone

+61 3 9076 8958

Fax

J.Faggian@nucleusnetwork.com.au

Contact person for scientific queries

Name

Jason Lickliter

Address

Centre for Clinical Studies, Nucleus Network Ltd
5th Floor, Burnet Building, AMREP Precinct,
89 Commercial Rd, Melbourne, VIC, 3004

Country

Australia

Phone

+61 3 9076 8960

Fax

j.lickliter@nucleusnetwork.com.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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 Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	A Cathepsin-Targeted Quenched Activity-Based Probe Facilitates Enhanced Detection of Human Tumors during Resection.	2022	https://dx.doi.org/10.1158/1078-0432.CCR-22-1215
Embase	Cathepsin detection to identify malignant cells during robotic pulmonary resection.	2023	https://dx.doi.org/10.21037/tlcr-23-370
Dimensions AI	Fluorescent Probes for Imaging in Humans: Where Are We Now?	2023	https://doi.org/10.1021/acsnano.3c03564

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically