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NOT YET RECRUITING
NCT07671027
EARLY_PHASE1

PIEZO-101 First-in-Human Safety and Proof-of-Concept Study

Sponsor: Piezo Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

40 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

8

Start Date

2026-09

Completion Date

2027-08

Last Updated

2026-06-26

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

PIEZO-101

Plasmid DNA biostimulator

DEVICE

Piezopen

Intradermal electroporation device

OTHER

Sterile Saline (0.9% NaCl)

Intra-participant comparator (control)