Created at Source Raw Value Validated value
June 17, 2021, 12:45 a.m. oms

Part A &B • To evaluate the safety and tolerability of enoxaparin administered via inhalation (IH) using a single and multiple ascending dose schedule in healthy adult volunteers. [Part A & BSafety and tolerability endpoints/outcome assessments include:• Incidence; type and severity of AEs• Changes from baseline in vital sign measurements• Changes from baseline in clinical laboratory parameters (Hematology; Coagulation; Biochemistry and Urinalysis)• Changes from baseline in electrocardiogram (ECG) parameters• Changes from baseline in physical examination findings including auscultation• Changes from baseline in oxygen saturation (SpO2)• Changes from baseline in lung spirometryPart A outcomes will be measured at the following timepoints: Baseline; Day 1;2; Day 3-7; Day 8. Part B outcomes will be measured at the following timepoints: Baseline; Day 1;2;3;4;5;6;7 Day 8-13; Day 14. ];Part C• To evaluate the safety and tolerability of inhaled enoxaparin administered in healthy volunteers using a multiple dose schedule in combination with inhaled N-acetylcysteine (NAC) treatment.[Part CSafety and tolerability endpoints/outcome assessments include:• Incidence; type and severity of AEs• Changes from baseline in vital sign measurements• Changes from baseline in clinical laboratory parameters (Hematology; Coagulation; Biochemistry and Urinalysis)• Changes from baseline in electrocardiogram (ECG) parameters• Changes from baseline in physical examination findings including auscultation• Changes from baseline in oxygen saturation(SpO2)• Changes from baseline in lung spirometryPart C outcomes will be measured at the following timepoints: Baseline; Day 1;2;3;4;5;6;7;8;9;10;11; Day 12-16; Day 17. ];Part D• To evaluate the safety and tolerability of inhaled enoxaparin when administered as an adjunct to inhaled N-acetylcysteine therapy in COVID-19 patients with moderate illness.[Part DSafety and tolerability endpoints/outcome assessments include:• Incidence; type and severity of AEs• Changes from baseline in vital sign measurements• Changes from baseline in clinical laboratory parameters (Hematology; Coagulation; Biochemistry and Urinalysis)• Changes from baseline in electrocardiogram (ECG) parameters• Changes from baseline in physical examination findings including auscultation• Changes from baseline in oxygen saturation• Changes from baseline in lung spirometryPart D outcomes will be measured at the following timepoints: Baseline; Day 1;2;3;4;5;6;7;8; Day 9-14; Day 15; Days 16-28;Day 29. ]

Part A &B • To evaluate the safety and tolerability of enoxaparin administered via inhalation (IH) using a single and multiple ascending dose schedule in healthy adult volunteers. [Part A & BSafety and tolerability endpoints/outcome assessments include:• Incidence; type and severity of AEs• Changes from baseline in vital sign measurements• Changes from baseline in clinical laboratory parameters (Hematology; Coagulation; Biochemistry and Urinalysis)• Changes from baseline in electrocardiogram (ECG) parameters• Changes from baseline in physical examination findings including auscultation• Changes from baseline in oxygen saturation (SpO2)• Changes from baseline in lung spirometryPart A outcomes will be measured at the following timepoints: Baseline; Day 1;2; Day 3-7; Day 8. Part B outcomes will be measured at the following timepoints: Baseline; Day 1;2;3;4;5;6;7 Day 8-13; Day 14. ];Part C• To evaluate the safety and tolerability of inhaled enoxaparin administered in healthy volunteers using a multiple dose schedule in combination with inhaled N-acetylcysteine (NAC) treatment.[Part CSafety and tolerability endpoints/outcome assessments include:• Incidence; type and severity of AEs• Changes from baseline in vital sign measurements• Changes from baseline in clinical laboratory parameters (Hematology; Coagulation; Biochemistry and Urinalysis)• Changes from baseline in electrocardiogram (ECG) parameters• Changes from baseline in physical examination findings including auscultation• Changes from baseline in oxygen saturation(SpO2)• Changes from baseline in lung spirometryPart C outcomes will be measured at the following timepoints: Baseline; Day 1;2;3;4;5;6;7;8;9;10;11; Day 12-16; Day 17. ];Part D• To evaluate the safety and tolerability of inhaled enoxaparin when administered as an adjunct to inhaled N-acetylcysteine therapy in COVID-19 patients with moderate illness.[Part DSafety and tolerability endpoints/outcome assessments include:• Incidence; type and severity of AEs• Changes from baseline in vital sign measurements• Changes from baseline in clinical laboratory parameters (Hematology; Coagulation; Biochemistry and Urinalysis)• Changes from baseline in electrocardiogram (ECG) parameters• Changes from baseline in physical examination findings including auscultation• Changes from baseline in oxygen saturation• Changes from baseline in lung spirometryPart D outcomes will be measured at the following timepoints: Baseline; Day 1;2;3;4;5;6;7;8; Day 9-14; Day 15; Days 16-28;Day 29. ]