Created at Source Raw Value Validated value
Nov. 5, 2021, 2:05 p.m. oms

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]

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]

April 30, 2021, 1:45 a.m. oms

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 and 6; and Day 56 for Cohort 2;Physical examinations in Cohorts 1; 3; 4; 5 and 6 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 and 6 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 and 6 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 28ECGs 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 56Vital signs in Cohorts 1; 3; 4; 5 and 6 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];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 and 6; and Day 56 for Cohort 2;Physical examinations in Cohorts 1; 3; 4; 5 and 6 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 and 6 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 and 6 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 28ECGs 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 56Vital signs in Cohorts 1; 3; 4; 5 and 6 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];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]