A study to compare the pharmacokinetics and pharmacodynamics of the free base form of PRTX007, the hydrochloride salt form of PRTX007 and the hydrochloride salt form of PRTX007 in combination with probenecid in healthy adults

Exclusion Criteria29

• Has an active malignancy, or history of malignancy, excluding basal or squamous cell carcinoma of the skin, within 2 years prior to screening
• 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. Clinically significant screening values measured after 5 minutes of rest in a supine position include:
• a. Abnormal systolic blood pressure (<90 or > 150 mmHg)
• b. Abnormal diastolic blood pressure (<40 or > 95 mmHg)
• c. Abnormal respiratory rate (<10 or > 22 bpm)
• Has a clinically significant history or presence of electrocardiogram (ECG) findings as judged by the PI or designee at screening, including:
• a. Abnormal sinus rhythm (heart rate <40 bpm or > 100 bpm);
• b. Average QT interval corrected using Fridericia’s formula (QTcF) interval duration >
• msec for males and > 470 msec for females;
• c. Average QRS interval > 120 msec after being confirmed by manual over-read
• d. Average PR interval > 220 msec
• Has clinically significant laboratory abnormalities including:
• a. Impaired renal function (serum creatinine levels >106 µmol/L) at screening.
• b. Alanine aminotransaminase (ALT) or aspartate aminotransaminase (AST) laboratory
• values >1.5X upper normal limits.
• c. Subject has an estimated creatinine clearance of <80 mL/min as determined by the
• Cockcroft-Gault equation
• Laboratory screening can be repeated upon investigator discretion.
• History of prescription drug abuse or illicit drug use within 6 months prior to screening
• History of moderate or severe psychiatric illness, based on physician’s judgement
• History of alcohol abuse defined as an average daily intake >3 units, or an average weekly intake >21 units, where 1 unit is equivalent to 1 can or bottle (355mL) of beer, or 1 measure (25mL) of spirits, or 1 glass (175 mL) of wine within 5 years prior to screening
• Positive alcohol breath test or urine test for drugs of abuse
• 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
• 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; prior participation at any time in non-invasive methodology trials in which no drugs were given is acceptable. Receipt of the COVID-19 vaccine will be allowed up to 14 days prior to the first dose of study drug. Subjects will not be allowed to receive the COVID-19 vaccine from 14 days prior to the first dose through to 7 days after the last dose of study drug.
• Has prior exposure to PRTX007
• 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
• 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
• 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
• Other unspecified reasons that, in the opinion of the PI or Sponsor, make the subject unsuitable for enrollment.