None listed
Conditions
Brief summary
This project is testing the safety and pharmacokinetics and pharmacodynamics of single and multiple oral doses of a new drug called PRTX007. PRTX007 is being developed for the treatment of patients with COVID-19 and the prevention of viral infection in adults and children exposed to SARS-CoV-2 You may be eligible for this study if you are a healthy adult man or woman aged between 18 and 65 years old. In Cohorts 1 through 8, participants will be randomised (assigned randomly, like flipping a coin) to receive single oral dose(s) of either the active study drug or placebo. In Cohorts 9 through 12, participants will be randomised (assigned randomly, like flipping a coin) to receive multiple oral dose(s) of either the active study drug or placebo. For subjects in Cohorts 1, 3, 4, 5, 6, 7 and 8, study participation will require 29 calendar days which will include 4 days (3 nights) in the CRU. For subjects in Cohort 2, study participation will require 56 calendar days which will include two stays of 4 days (3 nights) each in the CRU. For subjects in Cohorts 9, 10, 11 and 12, study participation will require 42 calendar days which will include 15 days (14 nights) in the CRU. It is hoped that this research will help determine the safety of PRTX007 when given to healthy men or women so that it can be tested in patients with COVID-19.
Interventions
Approximately 112 healthy men or women will be enrolled in this study. There will be two parts to the study.
In the first part of the study approximately 72 healthy men and women will be enrolled in up to 9 single ascending dose cohorts comprising 8 subjects each. Subjects within each cohort will be randomised to receive a single dose of either oral PRTX007 (6 subjects) or oral placebo (2 subjects). All cohorts will be started with sentinel dosing. All doses will be administered under direct ob
Approximately 112 healthy men or women will be enrolled in this study. There will be two parts to the study. In the first part of the study approximately 72 healthy men and women will be enrolled in up to 9 single ascending dose cohorts comprising 8 subjects each. Subjects within each cohort will be randomised to receive a single dose of either oral PRTX007 (6 subjects) or oral placebo (2 subjects). All cohorts will be started with sentinel dosing. All doses will be administered under direct observation in the Phase 1 unit. The doses for each cohort are shown below Cohort 1: 50mg Cohort 2: 100mg Cohort 3: 150mg Cohort 4: 200mg Cohort 5: 300mg Cohort 6: 400 mg Cohort 7: 500 mg Cohort 8: 600 mg Cohort 13: 800mg In the second part of the study approximately 40 healthy men and women will be enrolled into up to 4 multiple ascending dose cohorts comprising 10 subjects each. Subjects within each cohort will be randomised to receive multiple doses of either oral PRTX007 (8 subjects) or oral placebo (2 subjects). Each dose regimen will be administered every other day for 13 calendar days (7 total doses). All doses will be administered under direct observation in the Phase 1 unit. Final dose selection for the second part of the study will be based upon the data from the first part of the study. The currently proposed doses for each cohort are shown below Cohort 9: 300mg every other day Cohort 10: 400mg every other day Cohort 11: 500mg every other day Cohort 12: 750 mg every other day
Sponsors
Primmune Therapeutics Australia Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
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 from screening through 30 days post- dose. 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 from screening through 90 days post-dose and agree not to donate sperm during this period. 3. Is judged to be in good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests performed at the screening visit and/or before the first dose of study drug. 4. Weigh at least 45 kg at the time of screening 5. Have a body mass index (BMI) between 18.0 and 32.0 kg/m2 at the time of screening 6. Negative SARS-CoV2 test per site standards 7. Agrees to be available for all study visits and cooperate fully with the requirements of the study protocol, including the schedule of assessments 8. Willing to refrain from over-the-counter or prescription medications or herbal, nutritional or dietary supplements from 7 days before first dose through the end of study. 9. Willing to refrain from alcohol and caffeine from 48 hours before first dose through the last dose of study drug 10. Subjects who smoke no more than 2 cigarettes or equivalent per week can be included in the study but must be willing to abstain from smoking during the confinement period. 11. Willing and able to provide written informed consent
Exclusion criteria
1.. Has an active malignancy, or history of malignancy, excluding basal or squamous cell carcinoma of the skin, within 2 years prior to screening 2.. History of cardiovascular, cerebrovascular, or peripheral vascular disease, including, but not limited to, unstable angina, myocardial infarction, congestive heart failure, cardiac arrhythmia, hypertension, hypotension, or tachycardia. 3. Has a clinically significant history or presence of electrocardiogram (ECG) findings as judged by the PI or designee at screening 4. Has clinically significant laboratory abnormalities 5. History of prescription drug abuse or illicit drug use within 6 months prior to screening 6. History of alcohol abuse within 5 years prior to screening 7. Positive alcohol breath test or urine test for drugs of abuse 8. Positive test results for hepatitis B surface antigen, hepatitis B core antibodies, hepatitis C virus antigen, and anti-human immunodeficiency virus (HIV) type 1 antibody 9. Has received treatment with another investigational drug, investigational device, or approved therapy for investigational use within 30 days or 5 half-lives (whichever is longer) prior to dosing 10. Has donated blood or plasma within 30 days prior to screening, or had a loss of whole blood of more than 500 mL within the 30 days prior to screening, or receipt of a blood transfusion within one year prior to screening 11. Has experienced symptoms of acute illness or chronic disease within 14 days prior to screening, or any disease or condition (medical or surgical) that, by the determination of the PI, might compromise interpretation of safety or PK data, or would place the subject at risk as a result of participation in the study 12. Is unable to cooperate fully with the requirements of the study protocol, including the schedule of assessments, or likely to be non-compliant with any study requirements 13. Other unspecified reasons that, in the opinion of the PI or Sponsor, make the subject unsuitable for enrollment.
Outcome results
None listed