Phase 1b aKLmRNA Trial for Aging, 21 Subjects
Summary
A Phase 1b randomized, double-blind, placebo-controlled clinical trial (NCT07544420) evaluating aKLmRNA (AKL003), a novel mRNA-mediated protein replacement therapy formulated in lipid nanoparticles, will enroll approximately 21 subjects with the condition of aging. Subjects will be randomized in a 2:1 ratio (active treatment:placebo), with each receiving two injections of 0.5 mg aKLmRNA or saline placebo. The study is registered on ClinicalTrials.gov as a Phase 1 trial with an April 22, 2026 posting date.
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What changed
This document registers a new Phase 1b clinical trial on ClinicalTrials.gov. The study will evaluate the safety and tolerability of aKLmRNA (AKL003), an mRNA-mediated protein replacement therapy delivered via lipid nanoparticles, in approximately 21 subjects with aging. The trial employs a randomized, double-blind, placebo-controlled design with a 2:1 active-to-placebo ratio.
For sponsors and clinical investigators, this registry entry documents a novel mRNA therapeutic candidate entering early-phase clinical evaluation. Parties interested in aging research, mRNA therapeutics, or lipid nanoparticle delivery systems should monitor this trial for future enrollment updates and results postings.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
aKLmRNA-mediated Protein Replacement Therapy
Phase 1 NCT07544420 Kind: PHASE1 Apr 22, 2026
Abstract
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.
Conditions: Aging
Interventions: aKLmRNA (AKL003), Placebo
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