Clinical trials

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Condition / disease
Location
Status: Not yet recruiting

aKLmRNA-mediated Protein Replacement Therapy

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.

Participants needed: 21
Trial details
Phase: Phase 1Age: 50-75Biological sex: AllType: InterventionalSponsor: Klothea Bio IncUpdated: Apr 22, 2026Locations: 1
Eligibility criteria

Written informed consent (ICF) signed and dated by the patient [+5]

Known of suspected allergy to IMP or related procedure [+18]