Purified Exosome Product (PEP) Injected Into the Hypodermis

NCT06429033 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: PEP-23-002
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Safety

Outcome Measures

Primary Outcomes (7)

• Safety: Dose limiting toxicities

  The number of subjects with acute dose-limiting toxicities

  14-days

• Maximum Tolerated Dose

  The maximum tolerated dose determined by testing increasing doses of PEP

  14-days

• Incidence of withdrawls from the study due to treatment-emergent adverse events

  The number of subjects withdrawn from the study due to treatment-emergent adverse events

  30 days

• Incidence of Treatment-Emergent Adverse Events

  The number of subjects experiencing treatment emergent adverse events

  30 days

• Common Treatment Responses

  The number of subjects experiencing injection site reactions as noted in the patient diary

  14-days

• Laboratory Changes

  The number of subjects with changes and shifts from baseline in laboratory measurements

  30 days

• Application Site Reactions

  The number of subjects experiencing changes from baseline in treatment application site reactions

  14 days

Study Arms (1)

Treatment Group

EXPERIMENTAL

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.

Drug: PEP (Purified Exosome Product)

Interventions

PEP (Purified Exosome Product) DRUG

Injection of PEP into hypodermis of abdomen

Treatment Group

Eligibility Criteria

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

You may qualify if:

• Adult participants aged 18-65 (inclusive)
• Capacity to sign informed consent.
• Planned elective body reduction surgery to remove excess skin on the abdomen in ≥ 12 to ≤ 18 weeks
• Participant is judged, by the clinical investigator, to be healthy as evidenced by lack of clinically significant abnormal findings on medical history, physical examination, vital signs, and clinical laboratory tests.
• Participant should be willing to comply with the study procedure and schedule, including the follow up visit, and will refrain from using any other aesthetic treatment methods (laser devices, topical prescriptions, or other known hair growth treatments) in the treatment area during the entire study period.
• Females of childbearing potential must be using an approved method of birth control for the past month and during the entire study period. Participants who can become pregnant will undergo a pregnancy test prior to treatment.

You may not qualify if:

• Participants with clinically abnormal hematology, serum chemistries, or screening laboratory results as reviewed by the clinical investigator.
• Known history of MRSA (methicillin-resistant staphylococcus aureus).
• Known history of COVID-19 infection in past 6 months.
• COVID vaccine or booster dose within past 12 weeks.
• Participants who are positive for hepatitis B surface antigen (HbsAg), hepatitis C antibody, or HIV.
• History of antibiotic use in past 12 weeks.
• Major surgery in past 3 months.
• If taking hormone replacement therapy or hormones for birth control, dose must be stable for at least 6 months prior to study entry.
• Current or regular use of corticosteroids during the previous 4 weeks, excluding inhaled or topical steroids outside of the planned treatment area.
• Known sensitivity/allergy to study product ingredients.
• Pregnancy and nursing or lactating.
• Sexually active women of childbearing potential who are unwilling to use approved contraception method for three months after receiving dose of investigational drug.
• Impaired immune system due to immunosuppressive diseases such as AIDS and HIV or use of immunosuppressive medications.
• Clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurological, psychiatric, immunological, gastrointestinal, hematological, history of any malignancies or metabolic disease that is, in the opinion of the investigator, not stabilized or may otherwise impact the results of the study.
• Participants with hepatic impairment

Sponsors & Collaborators

• Clinical Testing of Beverly Hills: lead

Study Sites (1)

Clinical Testing of Beverly Hills

Encino, California, 91436, United States

Location

Study Officials

• John H Joseph, MD

  Clinical Testing Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 24, 2024
• Study Start: April 14, 2025
• Primary Completion: December 17, 2025
• Study Completion: December 18, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)