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

NCT07671027 | Not Yet Recruiting Early Phase 1

• 1 other identifier: PIEZO-101-001
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Skin aging; Decolette wrinkles; Knee skin laxity; Intradermal electroporation; Plasmid DNA; Biostimulator; Extracellular matrix regeneration; Skin rejuvenation; First-in-human

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of intradermal delivery of PIEZO-101 followed by Piezopen EP

  Described via Common Terminology Criteria for Adverse Events (CTCAE) v6.0 through Day 90, including clinical laboratory assessments (hematology, serum chemistry, inflammatory markers) and vital signs

  Up to 3 months

Secondary Outcomes (3)

• Characterize local tissue responses in treatment (PIEZO-101 + Piezopen EP) and control (saline) sites

  Up to 3 months

• Describe Piezopen EP procedural tolerability

  Up to 3 months

• Explore transgene mRNA expression 7 days after each dose

  Up to 3 months

Other Outcomes (3)

• Describe protein-level pharmacodynamic evidence in biopsy specimens from treated vs control sites

  Up to 3 months

• Explore aesthetic improvements over time

  Up to 3 months

• Describe anti-drug antibody (ADA) immunogenicity

  Up to 3 months

Study Arms (2)

Dose Level 1

EXPERIMENTAL

Four intradermal injections of PIEZO-101 at Dose Level 1 followed by Piezopen application in the left knee and décolleté each, along with four injections of saline control (intra-participant comparator) in the left knee. Administered on Day 0 and Day 28.

Biological: PIEZO-101; Device: Piezopen; Other: Sterile Saline (0.9% NaCl)

Dose Level 2

EXPERIMENTAL

Four intradermal injections of PIEZO-101 at Dose Level 2 followed by Piezopen application in the left knee and décolleté each, along with four injections of saline control (intra-participant comparator) in the left knee. Administered on Day 0 and Day 28.

Biological: PIEZO-101; Device: Piezopen; Other: Sterile Saline (0.9% NaCl)

Interventions

PIEZO-101 BIOLOGICAL

Plasmid DNA biostimulator

Dose Level 1; Dose Level 2

Piezopen DEVICE

Intradermal electroporation device

Dose Level 1; Dose Level 2

Sterile Saline (0.9% NaCl) OTHER

Intra-participant comparator (control)

Dose Level 1; Dose Level 2

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy female adults aged 40-65 years
• Fitzpatrick skin phototype score I-IV
• Visible signs of skin laxity, wrinkling, or crepiness in the knee area, confirmed by photographic documentation reviewed by at least two independent assessors
• Visible signs of wrinkling or crepiness in the décolleté area suitable for standardized photography, free of tattoos, significant scarring, or confounding skin conditions in the photography field, confirmed by photographic documentation reviewed by at least two independent assessors
• Willingness to undergo all protocol-required skin punch biopsies (four at Day 7 and four at Day 35) from the knee area
• Willingness to abstain from other aesthetic or dermatologic treatments in the knee and décolleté areas during the study
• For women of childbearing potential (WOCBP): commitment to use a highly effective method of contraception (combined hormonal contraception, progestogen-only contraception, intrauterine device or hormone-releasing system, bilateral tubal occlusion, vasectomized partner, or sexual abstinence) from the Screening Visit through the Day 90 End-of-Study visit. Postmenopausal status, defined as ≥12 months of natural amenorrhea, is not considered childbearing potential.
• Negative serum β-hCG pregnancy test at the Screening Visit (Visit 1) and negative urine pregnancy test at the treatment visits (Visit 2 and Visit 6) prior to dose for participants of child-bearing potential
• Willing and able to comply with all scheduled visits (10 study site visits), treatment plan, and study procedures for the full 90-day study duration
• Able to understand and willing to sign a written informed consent document.

You may not qualify if:

• History of keloid or hypertrophic scarring
• Known allergy or hypersensitivity to any antibiotic
• Known hypersensitivity to lidocaine, prilocaine, or any component of the topical anesthetic preparation
• Active dermatologic conditions or infections (such as psoriasis, eczema, active acne, or dermatitis) in the knee or décolleté treatment areas
• History of knee surgery or significant scarring in the knee treatment area; history of breast augmentation, reduction, or surgery resulting in scarring in the décolleté treatment area
• Use of systemic corticosteroids, immunosuppressants, or medications affecting wound healing within 30 days of Day 0
• Known autoimmune disease or immunodeficiency
• Pregnancy or breastfeeding
• Participation in another investigational study within 30 days of Day 0
• Known allergy to metals such as stainless steel
• Implanted electronic device (e.g., cardiac pacemaker, defibrillator, neurostimulator)
• Any aesthetic procedure (injectable, energy-based device, laser, filler, biostimulator, chemical peel, topical prescription product) in the knee or décolleté areas within 6 months of screening
• Tattoos, permanent makeup, or scarring in the knee or décolleté treatment areas that could interfere with clinical or photographic assessments
• History of any malignancy within 5 years prior to screening, except adequately treated basal cell or squamous cell carcinoma of the skin outside the treatment areas
• Any condition that, in the opinion of the PI, would compromise participant safety or study integrity.

Sponsors & Collaborators

• Piezo Therapeutics, Inc.: lead

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Within participant assignment, two dose levels evaluated with two cohorts

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 26, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share