Purified Exosome Product (PEP) Injected Into the Hypodermis (PEP)

A Prospective, Within-Subject Controlled Study to Evaluate the Safety and Histological Profile of Purified Exosome Product Into the Hypodermis of Healthy Adults

This clinical trial aims to learn if Purified Exosome Product (PEP) is safe and tolerable 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? Are there signals of Collagen I/II and Elastin biostimulation?

Subjects will serve as their own control and researchers will compare PEP to Control to see if PEP is safe.

Study Overview

• Status: Not yet recruiting
• Conditions: Safety
• Intervention / Treatment: Drug: Purified Exosome Product (PEP)

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 ≥ 12 to ≤ 18 weeks 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 histological findings (collagen, pre-collagen, elastin) as an exploratory endpoint. 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.

• Study Type: Interventional
• Enrollment (Estimated): 9
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Mary Hayes; Phone Number: 818-616-3880; Email: mary@clinicaltestingcenter.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adult participants aged 18-65 (inclusive)
• Capacity to sign informed consent.
• Planned elective body reduction surgery to remove excess skin on the abdomen in ≥ 3 to ≤ 5 months
• 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.

Exclusion Criteria:

• 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
• Participants with poorly controlled diabetes mellitus (HbA1C ≥ 8%).
• Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
• History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
• Any surgery or treatment such as laser or chemicals in the treatment area within 6 months prior to treatment
• Any medical condition that in the opinion of the investigator, such condition would compromise the safety of the participant or quality of the study data.
• Current, or past participation in a clinical trial within the past 30 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment Group; A single dose of 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 approximately 50 each 0.2 mL boluses, approximately 1cm apart.

Drug: Purified Exosome Product (PEP); Injection of PEP into hypodermis of abdomen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious Adverse Events	The number of subjects experiencing serious adverse events, as adjudicated by the Data Safety Monitoring Board (DSMB)	14 days
Adverse Events	The number of subjects experiencing adverse events	26-weeks
Common Treatment Responses (CTRs)	The number of CTRs experienced by the subject, as recorded in the diary	14-days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histopathology	Histology evaluation	6-months

Collaborators and Investigators

• Sponsor: Clinical Testing of Beverly Hills

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 15, 2024
• First Submitted That Met QC Criteria: May 20, 2024
• First Posted (Actual): May 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2024
• Last Update Submitted That Met QC Criteria: May 24, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: PEP-23-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No