Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624000832572p
Ethics application status
Submitted, not yet approved
Date submitted
27/06/2024
Date registered
5/07/2024
Date last updated
5/07/2024
Date data sharing statement initially provided
5/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 1, Single Centre, Open Label, Multiple Dose Study to Investigate the Safety and Pharmacokinetics of Ziverdox in Healthy Volunteers
Scientific title
A Phase 1, Single Centre, Open Label, Multiple Dose Study to Investigate the Safety and Pharmacokinetics of Ziverdox in Healthy Volunteers
Secondary ID [1] 312420 0
Nil known
Universal Trial Number (UTN)
U1111-1307-7794
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 334237 0
Condition category
Condition code
Respiratory 330902 330902 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive a single oral dose of 1 tablet of 137mg Ziverdox every day for 10 days (Day 1 to Day 10). On Days 1, 2, 3, 4, 6 and 8 participants will be given the daily dose at the clinic under supervision. On Days 5, 7 and 9 participants will take the daily dose at home and will record that they have done this in the participant diary.
Intervention code [1] 328927 0
Treatment: Drugs
Comparator / control treatment
There will be no control group. All participants will receive Ziverdox.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338662 0
Safety and tolerability of Ziverdox
Timepoint [1] 338662 0
AEs and SAEs will be collected from screening throughout the study. Screening -Day 28 to Day 22
Vital signs will be done from Screening and throughout the study.
Safety labs on: Screening Day -28 to -2, Day -1, 2, 4, 6, 9, 11 and 22.
Physical Exams: Screening Day-28 to -2, -1, 9 and 22.
Self Reported Events to be captured on Days -1 to 22.
Secondary outcome [1] 436899 0
PK of Ziverdox
Timepoint [1] 436899 0
PK samples will be taken on Day 1, 90 mins prior to dosing, then at 0.5, 1, 1.5 2, 2.5, 3, 4, 5, 6, 8 and 12 hours post dose. Samples will be taken on Day 2, 90 mins prior to dose and 12 hours post dose then on Day 3 90 mins prior to dose, Day 4 120 mins prior to dose, Day 6 120 mins prior to dose, Day 8 120 mins prior to dose and on Day 10 90 mins prior to dose and 30 mins post dose then 0.5, 1.5, 2, 2.5, 3, 4, 5, 6, 8 and 12 hours post dose then on Day 11, 24 hours post dose and 36 hours post dose, on Day 12 48 hours post dose and on Day 13 72 hours post dose.

Eligibility
Key inclusion criteria
1. Healthy Volunteers
2. Male or Female
3. BMI 18.0-35.0 kg/m2,
4. Weight >50kgs
5. HREC worded Contraception for both males and females. Including male partners.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Presence or history of any cardiovascular, gastrointestinal, renal, hepatic, respiratory, hematological, immunological, dermatological, neurological, or psychiatric/psychological condition, which is considered to be clinically significant by the investigator or delegate.
2. Any concomitant disease or condition that could interfere with the conduct of the study or that would, in the opinion of the investigator, pose an unacceptable risk to the participant.
3. Normal hematologic and hepatic function defined as liver function tests = 1.5 x upper limit of normal and estimated glomerular filtration rate > 59 and determined by clinical lab results. Repeat tests may be conducted at the discretion of the investigator.
4. Clinically relevant abnormal laboratory results, 12-lead electrocardiogram (ECG) and vital signs, or physical findings at screening and/or Day -1 as judged by the investigator. Tests performed during screening may be repeated once at the discretion of the investigator to confirm eligibility.
5. Use of prescription medication 14 days prior to dosing on Day 1 until the end of study (EOS) visit. Exceptions are hormone replacement therapy and contraception. Additional exceptions may apply on a case-by-case basis if considered not to interfere with the objectives of the study, at the discretion of the investigator and/or medical monitor.
6. Use of over-the-counter medications in the 7 days or 5 half-lives before dosing on Day 1 until the EOS visit. Exceptions are paracetamol (up to 2 gm/day) and vitamins. Additional exceptions may apply on a case-by-case basis if considered not to interfere with the objectives of the study, at the discretion of the investigator and/or medical monitor.
7. Active COVID-19 infection or COVID-19 infection within the last 3 months prior to screening. Long COVID-19 not resolved for longer than 3 months.
8. Treatment with an investigational drug or device within 30 days or 5 half-lives (whichever is longer) prior to screening.
9. Known allergy to the investigational product or any of its components.
10. Participants have donated or received any blood or blood products within 3 months prior to dosing.
11. Unwilling to abstain from grapefruit-containing foods or beverages or Seville orange-containing foods or beverages from 48 hours prior to investigational product administration and during the confinement periods.
12. Unwilling to refrain from alcohol consumption from 48 hours prior to investigational product administration and during the confinement periods.
13. Unwilling to refrain from consuming caffeine/xanthine beverages or food (tea, coffee, chocolate), from 48 hours prior to investigational product administration and during the confinement periods.
14. Unwilling to avoid heavy exercise (eg, marathon runners, weightlifters) from 48 hours prior to investigational product administration and during the confinement periods.
15. Unwilling to refrain from use of nicotine containing products from 48 hours prior to investigational product administration and during the confinement period/s. Products approved for smoking cessation such as nicotine patches, gum and lozenges may be allowed throughout the study at the investigator’s discretion.
16. Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the study or result in incomplete or poor-quality data.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/07/2024
Actual
Date of last participant enrolment
Anticipated
5/08/2024
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 26739 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 42787 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 316833 0
Commercial sector/Industry
Name [1] 316833 0
Topelia Aust Ltd
Country [1] 316833 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Topelia Aust Ltd
Address
Country
Australia
Secondary sponsor category [1] 319065 0
None
Name [1] 319065 0
Address [1] 319065 0
Country [1] 319065 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315601 0
Bellberry Human Research Ethics Committee H
Ethics committee address [1] 315601 0
Ethics committee country [1] 315601 0
Australia
Date submitted for ethics approval [1] 315601 0
22/05/2024
Approval date [1] 315601 0
Ethics approval number [1] 315601 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135210 0
Dr Mohamed Bakra
Address 135210 0
CMAX Clinical Research. 21-24 North Terrace, Adelaide SA 5000
Country 135210 0
Australia
Phone 135210 0
+61870887900
Fax 135210 0
Email 135210 0
[email protected]
Contact person for public queries
Name 135211 0
David Fox
Address 135211 0
Topelia Aust. 1/229 Great N Rd, Five Dock NSW 2046
Country 135211 0
Australia
Phone 135211 0
+61 498 807 203
Fax 135211 0
Email 135211 0
[email protected]
Contact person for scientific queries
Name 135212 0
David Fox
Address 135212 0
Topelia Aust. 1/229 Great N Rd, Five Dock NSW 2046
Country 135212 0
Australia
Phone 135212 0
+61 498 807 203
Fax 135212 0
Email 135212 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.