COVID-19 trials registries data warehouse

https://anzctr.org.au/ACTRN12621000468820.aspx

Dr. Charlotte Lemech

charlotte.lemech@scientiaclinicalresearch.com.au

2021-04-20

Recruiting

RCT

Randomized

Parallel

Blind label

single-center

Prevention

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

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.

8

Primmune Therapeutics Australia Pty Ltd

18

65

Australia

Healthy volunteers

N/A

104

To evaluate the safety of multiple doses of PRTX007 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); chemistry (standard panel) and urinalysis (standard panel)[Treatment-emergent adverse events will be collected from the time of signing the informed consent form through the final follow-up visit which is on Day 42;Physical examinations will be conducted at screening; on Day -1; Day 14; Day 21 and Day 42.Clinical laboratory assessments of blood and urine will be collected at screening; on Day -1; Day 2; Day 3; Day 4; Day 5; Day 6; Day 7; Day 9; Day 11; Day 13; Day 14; Day 21 and Day 42.ECGs will be collected at screening; and pre-dose and 2 hours post dose on Day 1; Day 3 ; Day 5; Day 7; Day 9; Day 11 and Day 13 and on Day 42Vital signs will be collected at screening; on Day -1; pre-dose and 1; 2; 3; 4 and 6 hours post dose on Day 1; Day 3 ; Day 5; Day 7; Day 9; Day 11 and Day 13 and on Day 14; Day 21 and Day 42];To evaluate the safety of single doses of PRTX007 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 assessed using a digital thermometer and respiratory rate measured using a manual counting of breaths per minute; ECG data; and clinical laboratory assessments of blood and urine: hematology (standard panel); chemistry (standard panel) and urinalysis (standard panel)[Treatment-emergent adverse events will be collected from the time of signing the informed consent form through the final follow-up visit which is Day 28 for Cohorts 1; 3; 4; 5; 6; 7 and 8; and Day 56 for Cohort 2; Physical examinations in Cohorts 1; 3; 4; 5; 6; 7 and 8 will be conducted at screening; Day -1; Day 3; Day 5 and Day 28. Physical examinations in Cohort 2 will be conducted at screening; Day -1; Day 3; Day 5; Day 28; Day 31; Day 33 and Day 56. Clinical laboratory assessments of blood and urine in Cohorts 1; 3; 4; 5; 6; 7 and 8 will be collected at screening; Day -1; Day 2; Day 3; Day 5 and Day 28. Clinical laboratory assessments of blood and urine in Cohort 2 will be collected at screening; Day -1; Day 2; Day 3; Day 5; Day 28; Day 30; Day 31; Day 33 and Day 56. ECGs in Cohorts 1; 3; 4; 5; 6; 7 and 8 will be collected at screening; Day -1 and Day 1 at 30; 60; and 90 minutes; and 2; 3; 4; 6; 8; and 12 hours after dosing; Day 2 at 24 hours post dose; and at Day 28 ECGs in Cohort 2 will be collected at screening; on Day -1 and on Day 1 at 30; 60; and 90 minutes; and 2; 3; 4; 6; 8; and 12 hours after dosing; Day 2 at 24 hours post dose; Day 28; Day 29 at 30; 60; and 90 minutes; and 2; 3; 4; 6; 8; and 12 hours after dosing; Day 30 at 24 hours post dose; and at Day 56 Vital signs in Cohorts 1; 3; 4; 5; 6; 7 and 8 will be collected at screening; Day -1; Day 1 pre-dose and 1; 2; 4; 8; and hours post dose; Day 2; Day 3; Day 5 and Day 28. Vital signs in Cohort 2 will be collected at screening; Day -1; Day 1 pre-dose and 1; 2; 4; 8; and hours post dose; Day 2; Day 3; Day 5; Day 28; Day 29 pre-dose and 1; 2; 4; 8; and hours post dose; Day 30; Day 31; and Day 56]

Phase 1

[{"arm_notes": "50mg", "treatment_id": 1035, "treatment_name": "Prtx007", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "100mg", "treatment_id": 1035, "treatment_name": "Prtx007", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "150mg", "treatment_id": 1035, "treatment_name": "Prtx007", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "200mg", "treatment_id": 1035, "treatment_name": "Prtx007", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "300mg", "treatment_id": 1035, "treatment_name": "Prtx007", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "400 mg", "treatment_id": 1035, "treatment_name": "Prtx007", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "500 mg", "treatment_id": 1035, "treatment_name": "Prtx007", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "600 mg", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]