This is a Phase 1b randomized, double-blind, placebo-controlled study to assess the safety and tolerability of a proprietary aKLmRNA formulated in lipid nanoparticles. Approximately 21 subjects will be enrolled. Each subject will receive a total of two injections during the study. The cohort will consist of approximately 21 subjects, with each receiving 0.5 mg aKLmRNA (AKL003) or placebo. Subjects will be randomized in a 2:1 ratio (active treatment:placebo). The placebo will be saline, matching the active treatment in both appearance and volume.
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Overall incidence and severity of unsolicited AEs by treatment group
Timeframe: From first dose through end of study (Day 60)
β’ Overall incidence and severity of solicited reactogenicity events by treatment group
Timeframe: From first dose through end of study (Day 60)