A Phase 1, Single Centre, Open Label, Multiple Dose Study to Investigate the Safety and Pharmacokinetics of Ziverdox in Healthy Volunteers

Phase 1

• Conditions: Respiratory - Other respiratory disorders / diseases; COVID-19

• Registration Number: ACTRN12624000832572
• Lead Sponsor: Topelia Aust Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-05
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 8

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.; 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.

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.; 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

• Study Type: Interventional
• Study Design: Not specified