U.S., April 23 -- ClinicalTrials.gov registry received information related to the study (NCT07544420) titled 'aKLmRNA-mediated Protein Replacement Therapy' on April 05.
Brief Summary: 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.
Study Start...