Purified Exosome Product (PEP) Injected Into the Hypodermis

Part of paid clinical trials in Encino, California.

Sponsor
Clinical Testing of Beverly Hills
Study ID
NCT06429033
Phase
PHASE1
Status
Completed

Conditions

  • Safety

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • PEP (Purified Exosome Product) — DRUG
    Injection of PEP into hypodermis of abdomen

Study Details

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.

Key Dates

First listed
May 24, 2024
Start date
Apr 14, 2025
Status verified
Dec 2025
Primary completion
Dec 17, 2025
Completion
Dec 18, 2025

Study Design

Enrollment
8 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Experimental: Treatment Group
    A single dose of PEP (Purified Exosome Product) in Lactated Ringers at doses of 1 vial (75 mg) (Low Dose/Cohort 1) or 2 vials (150 mg) (Target Dose/Cohort 2) will be injected intradermally into the hypodermis of a 5 cm by 10 cm section of abdomen (to the right of the umbilicus) that is planned for removal during abdominoplasty surgery. The solution will be injected into the hypodermis in retrograde linear threads.

Primary Outcome Measure

Safety: Dose limiting toxicities [ Time Frame: 14-days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Clinical Testing of Beverly HillsEncinoCalifornia91436-

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Clinical Testing of Beverly Hills· Encino, CA

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