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

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Approximately 104 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 64 healthy men and women will be enrolled in up to 8 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 belowCohort 1: 50mgCohort 2: 100mgCohort 3: 150mgCohort 4: 200mgCohort 5: 300mgCohort 6: 400 mgCohort 7: 500 mgCohort 8: 600 mgIn 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 belowCohort 7: 300mg every other dayCohort 8: 400mg every other dayCohort 9: 500mg every other dayCohort 10: 600 mg every other day", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"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"}]

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

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Approximately 88 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 48 healthy men and women will be enrolled in up to 6 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 belowCohort 1: 50mgCohort 2: 100mgCohort 3: 150mgCohort 4: 200mgCohort 5: 300mgCohort 6: 400 mgIn 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 belowCohort 7: 100mg every other dayCohort 8: 200mg every other dayCohort 9: 300mg every other dayCohort 10: 400 mg every other day", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]