An Open-Label, Within Participant-Controlled, First-in-Human (FIH) Study to Explore the Safety, Tolerability, and Pharmacodynamic Effects of PIEZO-101, an Investigational Plasmid DNA Biostimulator Delivered by Intradermal Electroporation to the Knee and Décolleté Regions in Healthy Adult Female Participants

The aim of this first-in-human clinical study is to explore the safety, tolerability, pharmacodynamics, and exploratory efficacy of PIEZO-101, an investigational plasmid DNA biostimulator that aims to restore expression of key proteins in the skin for extracellular matrix rejuvenation. PIEZO-101 is administered using an intradermal injection followed by localized electroporation using the investigational device Piezopen. This clinical trial will study safety and tolerability, pharmacodynamics using biopsies from the left knee, and exploratory efficacy using photography on the décolleté. Up to 8 participants may be enrolled to ensure 6 evaluable participants complete the study.