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

[{"arm_notes": "", "treatment_id": null, "treatment_name": "This is a single centre; double-blind randomised placebo-controlled study to assess the safety; tolerability; and pharmacokinetics of nebulised IN-006 in healthy volunteers. The study will be enrolled in 3 cohorts. Subjects will only be allowed to enrol in one cohort.1. 2 cohorts of single-ascending dose (SAD) cohorts: The first cohort will enrol 8 subjects; randomised to receive a single low dose of IN-006 or placebo. In the second cohort; 8 subjects will be randomised to receive a single high dose of IN-006 or placebo.2. The last cohort is a multiple-dose (MD) cohort where 8 subjects will be randomised to receive a daily dose of IN-006 or placebo for 7 days. The dose will be determined from the safety data from SAD.All subjects will receive IN-006 or placebo via a nebulizer which will be administered by the study site staff while in the clinic.A Dose Escalation Committee (DEC) will review the safety data of the first 24 hours of SAD Cohort 1 before proceeding to SAD Cohort 2. A second DEC meeting will review safety data through Day 8 of Cohort 1 and the first 24 hours of SAD COhort 2 to determine the dose that will be administered in the MD cohort.", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "", "treatment_id": 1912, "treatment_name": "Regdanvimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]