Created at Source Raw Value Validated value
Sept. 17, 2021, 4 a.m. oms

The primary objective is to evaluate the safety and tolerability of nebulized IN-006 in healthy volunteers following a single dose of IN-006.Safety and tolerability assessments will include vital signs (including FEV1 and SpO2); safety labs; ECG; and physical exams.[Vital signs including FEV1 and SpO2 will be collected at:Screening; Day -1 (the day prior to dosing); Dosing Day 1; Day 2 at 24 hours post-dose; Day 4 (72 hr); Day 6 (120 hr); Day 8 (168 hr); Day 15; and Day 29 (End Of Study [EOS]). Vitals signs will be measured by an automated blood pressure machine. FEV1 will be measured by standard spirometry and SpO2 will be measured by a pulse oximeter.Safety labs will be collected at:Screening; Day -1 (the day prior to dosing); and post-dose on Day 2 (24 hours post-dose); Day 8 (168 hrs); and Day 29 (EOS).ECGs will be collected at Screening; Day -1 (the day prior to dosing); Day 2 (24 hours post-dose); and Day 29 (EOS);Complete physical exams will be completed at Screening; Day 2 (24 hours post-dose); and Day 29 (EOS); Symptom-directed exams may be conducted at any other time at the discretion of the investigator.];The primary objective is to evaluate the safety and tolerability of nebulized IN-006 in healthy volunteers following multiple doses of IN-006.Safety and tolerability assessments will include vital signs (including FEV1 and SpO2); safety labs; ECG; and physical exams.[Vital signs including FEV1 and SpO2 will be collected at:Screening; Day -1 (the day prior to dosing); Dosing Days 1 through 7; Day 8; Day 15; and Day 29 (EOS). Vitals signs will be measured by an automated blood pressure machine. FEV1 will be measured by standard spirometry and SpO2 will be measured by a pulse oximeter.Safety labs will be collected at:Screening; Day -1; and post-dose on Day 4 (72 hrs); Day 8 (168 hrs); Day 15; and Day 29.ECGs will be collected at Screening; Day -1 (the day prior to dosing); and post-dose on Day 8; and Day 29 (EOS);Complete physical exams will be completed at Screening; Day 8; and Day 29 (EOS); Symptom-directed exams may be conducted at any other time at the discretion of the investigator]

The primary objective is to evaluate the safety and tolerability of nebulized IN-006 in healthy volunteers following a single dose of IN-006.Safety and tolerability assessments will include vital signs (including FEV1 and SpO2); safety labs; ECG; and physical exams.[Vital signs including FEV1 and SpO2 will be collected at:Screening; Day -1 (the day prior to dosing); Dosing Day 1; Day 2 at 24 hours post-dose; Day 4 (72 hr); Day 6 (120 hr); Day 8 (168 hr); Day 15; and Day 29 (End Of Study [EOS]). Vitals signs will be measured by an automated blood pressure machine. FEV1 will be measured by standard spirometry and SpO2 will be measured by a pulse oximeter.Safety labs will be collected at:Screening; Day -1 (the day prior to dosing); and post-dose on Day 2 (24 hours post-dose); Day 8 (168 hrs); and Day 29 (EOS).ECGs will be collected at Screening; Day -1 (the day prior to dosing); Day 2 (24 hours post-dose); and Day 29 (EOS);Complete physical exams will be completed at Screening; Day 2 (24 hours post-dose); and Day 29 (EOS); Symptom-directed exams may be conducted at any other time at the discretion of the investigator.];The primary objective is to evaluate the safety and tolerability of nebulized IN-006 in healthy volunteers following multiple doses of IN-006.Safety and tolerability assessments will include vital signs (including FEV1 and SpO2); safety labs; ECG; and physical exams.[Vital signs including FEV1 and SpO2 will be collected at:Screening; Day -1 (the day prior to dosing); Dosing Days 1 through 7; Day 8; Day 15; and Day 29 (EOS). Vitals signs will be measured by an automated blood pressure machine. FEV1 will be measured by standard spirometry and SpO2 will be measured by a pulse oximeter.Safety labs will be collected at:Screening; Day -1; and post-dose on Day 4 (72 hrs); Day 8 (168 hrs); Day 15; and Day 29.ECGs will be collected at Screening; Day -1 (the day prior to dosing); and post-dose on Day 8; and Day 29 (EOS);Complete physical exams will be completed at Screening; Day 8; and Day 29 (EOS); Symptom-directed exams may be conducted at any other time at the discretion of the investigator]