Safety of TY027, a Treatment for COVID-19, in Humans

This is a Phase 1 First-in-Human, Time Lagged, Randomised, Placebo Controlled, Double Blind, Single Ascending Dose Study of TY027 in Healthy Adult Volunteers. Safety, tolerability and PK of TY027 will be assessed. The dose escalation will include 32 healthy volunteers across five (5) dose cohorts: * 0.5 mg/kg, N = 2 TY027 + 2 Placebos * 5 mg/kg, N = 5 TY027 + 2 Placebos * 10 mg/kg, N = 5 TY027 + 2 Placebos * 20 mg/kg, N = 5 TY027 + 2 Placebos * 30 mg/kg, N = 5 TY027 + 2 Placebos Subjects will be required to be inpatient at the trial site for approximately 24 hours. A minimum of 20-hour interval from the first two (2) subjects dosing (1 treatment and 1 placebo concurrently) must take place before the third subject can be dosed within the cohort. No such time interval will be required for dosing of subsequent subjects (fourth subject onwards) within the same dose cohort. After 24 hours, subjects will be discharged from the trial site and to return for scheduled follow-up visits. Subjects will be followed for up to approximately Day 84 with serum samples taken at specified times as per outlines in Table 1. Dose escalations will be guided by a safety review of clinical signs, adverse events (AEs), laboratory tests (excluding lipase) and immune gene expression data of the prior dose cohort (up to 72 hours post-dose). Subsequent post-trial monitoring through weekly telephone calls will continue from Day 85 onwards for another three (3) more months. Decisions not to dose escalate past any proposed dose level due to safety findings will not constitute a protocol violation. Safety summaries (up to Day 3 post-dose) will be generated for each dose cohort and delivered to the Dose Escalation Review Committee (DERC) for review. Interim analysis will be performed after Day 14 post-dose for each dose cohort and delivered to the Data Safety Monitoring Board (DSMB) for review.