NCT06429033

Purified Exosome Product (PEP) Injected Into the Hypodermis

A Phase 1 Controlled Study to Evaluate the Safety and Tolerability of Intradermal Administered Purified Exosome Product (PEP) in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Clinical Testing of Beverly Hills · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This clinical trial aims to characterize the safety, tolerability, and histological profile of PEP (Purified Exosome Product) when injected into the hypodermis of healthy adults. The main questions this study aims to answer are: Is PEP safe and tolerable when injected into the hypodermis of healthy adults? Subjects will serve as their own control and researchers will compare PEP to Control to see if PEP is safe.

Detailed description

This is a prospective, non-randomized, within-subject, controlled, single center, open-label study. Up to 9 healthy adult participants with planned elective body reduction surgery to remove excess skin on the abdomen in 30-45 days will be enrolled and injected with a single dose of PEP Drug Product reconstituted in Lactated Ringers (USP) solution in a defined area of the abdominal hypodermis. Similar tissue from the participant's contralateral side of the abdomen will serve as the control. Excised tissue will be harvested and analyzed for key biological markers for skin quality and senescence such as collagen and elastin. The primary goal of this investigator-initiated study is to determine safety of subcutaneous PEP Drug Product when reconstituted in Lactated Ringers solution. Safety data will be collected with frequent monitoring for adverse events, laboratory testing, vital signs, and ECGs. Note: The decision to undergo abdominoplasty will be made outside of this study and data/safety in the plastic surgery procedure for abdominoplasty, other than informed consent, will not be a collected as a part of this study.

Conditions

• Safety

Interventions

Type	Name	Description
DRUG	PEP (Purified Exosome Product)	Injection of PEP into hypodermis of abdomen

Timeline

• Start date: 2025-04-14
• Primary completion: 2025-12-17
• Completion: 2025-12-18
• First posted: 2024-05-24
• Last updated: 2025-12-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study