SafetyPhase 1PEPNCT06429033
Purified Exosome Product (PEP) Injected Into the Hypodermis
A Phase 1 study testing PEP (Purified Exosome Product) in people with Safety, run by Clinical Testing of Beverly Hills at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety
- What is being tested?
- PEP (Purified Exosome Product)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2025to 18 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
- History of excessive UV exposure (e.g., frequent sunburn, use of tanning beds, or prolonged outdoor activities without adequate sun protection)
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Testing of Beverly Hills
Encino, California, 91436
About this study
Official title: A Phase 1 Controlled Study to Evaluate the Safety and Tolerability of Intradermal Administered Purified Exosome Product (PEP) in Healthy Adults
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.
Read the 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
- Being tested
- PEP (Purified Exosome Product)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEP (Purified Exosome Product)Drug
Injection of PEP into hypodermis of abdomen
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: PEP (Purified Exosome Product) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Dose limiting toxicities
The number of subjects with acute dose-limiting toxicities
Measured: 14-days
Maximum Tolerated Dose
The maximum tolerated dose determined by testing increasing doses of PEP
Measured: 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
Measured: 30 days
Incidence of Treatment-Emergent Adverse Events
The number of subjects experiencing treatment emergent adverse events
Measured: 30 days
Common Treatment Responses
The number of subjects experiencing injection site reactions as noted in the patient diary
Measured: 14-days
Laboratory Changes
The number of subjects with changes and shifts from baseline in laboratory measurements
Measured: 30 days
Application Site Reactions
The number of subjects experiencing changes from baseline in treatment application site reactions
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start14 Apr 2025
- Primary completion17 Dec 2025
- Study completion18 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Testing of Beverly Hills
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John H Joseph, MD, Principal investigator, Clinical Testing Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06429033
- Sponsor's protocol ID
- PEP-23-002
- Acronym
- PEP
- Status last verified
- Dec 2025
- First submitted
- 15 May 2024
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Controlled Study to Evaluate the Safety and Tolerability of Intradermal Administered Purified Exosome Product (PEP) in Healthy Adults
- ClinicalTrials.gov ID
- NCT06429033
- Acronym / sponsor ID
- PEP / PEP-23-002
- Conditions
- Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Clinical Testing of Beverly HillsUniversity, hospital or other
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 17 Dec 2025 (actual)
- Study completion
- 18 Dec 2025 (actual)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: PEP (Purified Exosome Product)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEP (Purified Exosome Product)Injection of PEP into hypodermis of abdomen | Drug | Treatment Group |
Primary outcome
Safety: Dose limiting toxicities
Time frame: 14-days
The number of subjects with acute dose-limiting toxicities
Maximum Tolerated Dose
Time frame: 14-days
The maximum tolerated dose determined by testing increasing doses of PEP
Incidence of withdrawls from the study due to treatment-emergent adverse events
Time frame: 30 days
The number of subjects withdrawn from the study due to treatment-emergent adverse events
Incidence of Treatment-Emergent Adverse Events
Time frame: 30 days
The number of subjects experiencing treatment emergent adverse events
Common Treatment Responses
Time frame: 14-days
The number of subjects experiencing injection site reactions as noted in the patient diary
Laboratory Changes
Time frame: 30 days
The number of subjects with changes and shifts from baseline in laboratory measurements
Application Site Reactions
Time frame: 14 days
The number of subjects experiencing changes from baseline in treatment application site reactions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John H Joseph, MD principal investigator
Clinical Testing Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PEP (Purified Exosome Product) in people with Safety, run by Clinical Testing of Beverly Hills at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Dose limiting toxicities (time frame: 14-days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.