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Trial registered on ANZCTR


Registration number
ACTRN12624000245594
Ethics application status
Approved
Date submitted
19/02/2024
Date registered
13/03/2024
Date last updated
30/08/2024
Date data sharing statement initially provided
13/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase I, Randomized, Double-blind, Placebo-controlled, Single-Ascending-Dose (SAD) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of XG2002 Oral Administration in Healthy Adult Volunteers
Scientific title
A Phase I, Randomized, Double-blind, Placebo-controlled, Single-Ascending-Dose (SAD) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of XG2002 Oral Administration in Healthy Adult Volunteers
Secondary ID [1] 311367 0
PR-XG2002-01-PK-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute and Chronic Pain 332637 0
Condition category
Condition code
Neurological 329342 329342 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a double-blind, placebo-controlled, randomised, single dose escalation study. Approximately 48 participants will be enrolled sequentially into six ascending dose cohorts and will be randomised to receive either XG2002 or placebo as an oral capsule on Day 1.

Participants in each cohort will be required to fast for approximately 10 hours overnight prior to dosing on Day 1 with the dose ranging from 10 mg - 800mg of either XG2002 or matching placebo.

Core Body Temperature (CBT) will be measured by an ingested real-time monitoring device.

Dose escalation in each successive dose cohort will proceed in a sequential fashion after all relevant safety and tolerability data from all completed cohorts including the preceding dose cohort(s) have been reviewed by the Safety Review Committee (SRC). If it is not appropriate to escalate the dose level according to the proposed dose escalation schedule or intolerable dose level encountered (i.e., Stopping Criteria met), then an alternative sub-level dose may be given following discussion between the Sponsor and SRC (for example, if 800 mg dose is the intolerable dose, a cohort for 600 mg may be tested).

Adherence to study intervention will be conducted by study staff and recorded in the source document.
Intervention code [1] 327810 0
Treatment: Drugs
Comparator / control treatment
Placebo capsules are the same appearance, size, and capsule weight as those of XG2002 Capsules. The placebo capsules are filled with 100% microcrystalline cellulose with participants randomised to receive either XG2002 or placebo capsules orally on Day 1.
Control group
Placebo

Outcomes
Primary outcome [1] 337163 0
Composite Primary Outcome: To investigate the safety and tolerability of XG2002 following a single oral administration in healthy participants.
Timepoint [1] 337163 0
TEAEs will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 and assessed and recorded continuously as they occur from Day 1 post-dose through to Day 4 Exit Visit or Early Termination (EV/ET).
Core Body Temperature (CBT) will be measured via an ingested real-time monitoring device. CBT will be monitored in real-time for up to 24 hours post-dose with the device capsule being expelled in faeces naturally.
Secondary outcome [1] 430916 0
To evaluate systemic pharmacokinetic (PK) following single oral administration of XG2002 in healthy participants. A sub-intolerable dose level may be tested, for example, if 800 mg dose is the intolerable dose, a cohort for 600 mg may be tested.
Timepoint [1] 430916 0
Blood plasma samples will be collected pre-dose Day 1, 0.5 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr , 18 hr and 24 hrs post-dose.

Eligibility
Key inclusion criteria
1. Healthy male or female volunteers between 18 and 65 years of age, inclusive (at the
time of ICF).
2. Weight greater than or equal to 60 kg and a Body Mass Index (BMI) 18.0 to 35.0 kg/m2, inclusive.
3. Medically healthy, with no clinically significant medical conditions in the opinion of the Investigator.
4. Able to comprehend and provide voluntarily signed informed consent form, and to abide by the study restrictions and requirements.
5. Non-pregnant, non-breastfeeding female subjects may be enrolled if they are:
a. Surgically sterilized (verbal confirmation acceptable) or postmenopausal
(amenorrhea greater than or equal to 1 year and follicle-stimulating hormone greater than or equal to 30 mU/mL); or
b. Practicing true abstinence or an effective method of contraception from Screening visit until 3 months following the last dose of study drug, and must have a negative serum pregnancy test (women of childbearing potential [WOCBP] only) at screening and a negative urine pregnancy test (WOCBP only) on Day -1.
6. Male subjects may be enrolled if they are:
a. Surgically sterilized (vasectomy – verbal confirmation acceptable); or
b. Practicing true abstinence from Screening visit until 90 days following the last dose of study drug; or
c. Willing to use a condom during sexual activity, plus appropriate contraceptive measures for his female partner from Screening visit until 90 days after the last dose of study drug. This requirement does not apply to subjects in a same sex relationship and female partners of non-childbearing potential; and
d. Do not donate sperm for 90 days after last dose of study drug (non- vasectomized subjects).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Subjects with unstable or severe illness, including clinically significant malignancy, of hepatic, pulmonary, metabolic, neurologic, cardiovascular, gastrointestinal (e.g., inflammatory bowel disease), haematological, or psychiatric as indicated on medical history, physical examination, or clinical laboratory, vital signs, and ECGs evaluations, or in the opinion of the Investigator.
2. Subjects with clinically significant history of medical condition (in the opinion of the Investigator).
3. Subjects with any report of acute illness or febrile event that has not been resolved within 72 hours prior to dosing.
4. Subjects with any of the following laboratory test results at Screening:
a. creatinine clearance < 90 mL/min (estimated using the Cockcroft and Gault equation)
b. elevation of liver function tests: ALT, AST, GGT, bilirubin, or alkaline phosphatase > 1.5 times of the upper limit of normal range
c. leucocytes or lymphocytes < 1.5 times of the lower limit of normal
d. hemoglobin < the normal range of corresponding gender
5. Subjects with positive results for hepatitis B surface antigen (HbsAg) and/or hepatitis B anticore antibody (anti-HBc) but negative results for anti-surface antibody (antiHBs) at Screening visit
6. Positive results for hepatitis C antibody unless patient received curative therapy and a negative viral load is documented.
7. Human immunodeficiency virus (HIV) infection or positive HIV serology at the Screening Visit.
8. Subjects who have smoked more than 5 tobacco or nicotine-containing product (including nicotine patches) per week for 90 days prior to screening through to the end of the study.
9. Positive urine drug screen at Screening and Day -1, or positive alcohol breath test on Day -1.
10. Subjects who have not abstained from alcoholic beverages/alcohol-containing products at least 72 hours prior to drug administration, or plan to consume them through the completion of the follow-up visit.
11. Sleep pills 3 days prior to randomization and for the duration of the study
12. Unless a specific dietary need can be catered for at the study site, subjects with an abnormal diet including lactose/gluten intolerance, food rich with capsaicin or causing dysgeusia or other dietary restrictions (except vegetarian/vegan or religious dietary requirements), as determined by the Investigator 30 days prior to the study dosing.
13. Subjects with a history of donation of blood or blood products, or significant blood loss (>480ml) within 30 days prior to the study dosing.
14. Participation in another clinical trial with medicinal intervention within 30 days or 5 half-lived, whichever is longer, prior to the study dose.
15. Known or suspected hypersensitivity or idiosyncratic reaction to the study drug or its excipient.

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)
On Day 1, subjects will be assigned a unique number (randomisation number) in ascending numerical order at the study site. The randomisation number encodes the subject’s assignment to 1 of the 2 treatment arms of the study in that cohort. Access to the randomisation code will be strictly controlled according to the standard operating procedures of the CRO.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be generated prior to the study by the statistics department of the Contract Research Organization (CRO). Each subject will be dispensed blinded study intervention, that will be labelled with the subject’s unique randomisation number and will be used throughout the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/04/2024
Actual
15/04/2024
Date of last participant enrolment
Anticipated
16/09/2024
Actual
Date of last data collection
Anticipated
15/10/2024
Actual
Sample size
Target
32
Accrual to date
24
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 26122 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 41978 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 315627 0
Commercial sector/Industry
Name [1] 315627 0
Xgene Pharmaceutical Pty Ltd
Country [1] 315627 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Xgene Pharmaceutical Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 317723 0
Commercial sector/Industry
Name [1] 317723 0
Avance Clinical Pty Ltd
Address [1] 317723 0
Country [1] 317723 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314510 0
Bellberry Human Research Ethics Committee D
Ethics committee address [1] 314510 0
https://bellberry.com.au/
Ethics committee country [1] 314510 0
Australia
Date submitted for ethics approval [1] 314510 0
31/01/2024
Approval date [1] 314510 0
05/03/2024
Ethics approval number [1] 314510 0
2024-01-009

Summary
Brief summary
This is a randomised, double-blind, placebo-controlled, First-in-Human Study to assess the safety ofXG2002 and how this drug acts in the body in healthy volunteers. XG2002 may be indicated for use in patients with acute and chronic pain, but a trial of the drug in healthy volunteers is needed before trials in patients suffering from acute and chronic pain can proceed.

Who is it for?
You may be eligible for this study if you are aged 18 to 65 years and are in good general health without a clinically significant medical history.

Study details
All healthy volunteer participants who choose to enrol in this study will be assigned by chance to receive either a single dose of XG2002 or placebo. All participants will have their vital signs checked (heart rate, blood pressure with Core Body Temperature (CBT) being measured by an ingested real-time monitoring device), and will provide blood and urine samples for testing. If the drug appears safe, additional participants will be assigned by chance to receive a larger single dose of XG2002 or placebo, followed by blood and urine testing. This will continue until a maximum safe dose is determined.

It is hoped this research will determine the maximum dose of XG2002 that can be administered safely without causing severe reactions. Once the dose of XG2002 has been determined in healthy volunteers, a trial investigating the efficacy of XG2002 as a treatment for patients with acute and chronic pain may proceed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131842 0
Dr Jonathan Newchurch
Address 131842 0
CMAX Clinical Research Pty Ltd, Ground Floor, 21-24 North Terrace, Adelaide, South Australia, 5000
Country 131842 0
Australia
Phone 131842 0
+61 04 2322 3756
Fax 131842 0
Email 131842 0
[email protected]
Contact person for public queries
Name 131843 0
Jonathan Newchurch
Address 131843 0
CMAX Clinical Research Pty Ltd, Ground Floor, 21-24 North Terrace, Adelaide, South Australia, 5000
Country 131843 0
Australia
Phone 131843 0
+61 04 2322 3756
Fax 131843 0
Email 131843 0
[email protected]
Contact person for scientific queries
Name 131844 0
Jonathan Newchurch
Address 131844 0
CMAX Clinical Research Pty Ltd, Ground Floor, 21-24 North Terrace, Adelaide, South Australia, 5000
Country 131844 0
Australia
Phone 131844 0
+61 04 2322 3756
Fax 131844 0
Email 131844 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.