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

NCT07671027 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-06-26

No results posted yet for this study

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.

Conditions

  • Skin Aging
  • Wrinkles in Decolletage
  • Wrinkles in Left Knee
  • Left Knee Skin Laxity
  • Décolleté Wrinkles

Interventions

BIOLOGICAL

PIEZO-101

Plasmid DNA biostimulator

DEVICE

Piezopen

Intradermal electroporation device

OTHER

Sterile Saline (0.9% NaCl)

Intra-participant comparator (control)

Sponsors & Collaborators

  • Piezo Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-08-31
Completion
2027-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07671027 on ClinicalTrials.gov