Clinical trial NCT06429033: Purified Exosome Product (PEP) Injected Into the Hypodermis
Official title: A Phase 1 Controlled Study to Evaluate the Safety and Tolerability of Intradermal Administered Purified Exosome Product (PEP) in Healthy Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Safety
Lead sponsor: Clinical Testing of Beverly Hills
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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 ≥ 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.

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
* 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.

Primary outcomes:
measure: Safety: Dose limiting toxicities
timeFrame: 14-days
measure: Maximum Tolerated Dose
timeFrame: 14-days
measure: Incidence of withdrawls from the study due to treatment-emergent adverse events
timeFrame: 30 days
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 30 days
measure: Common Treatment Responses
timeFrame: 14-days
measure: Laboratory Changes
timeFrame: 30 days
measure: Application Site Reactions
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Encino
country: United States
facility: Clinical Testing of Beverly Hills
state: California
Study officials:
affiliation: Clinical Testing Center
name: John H Joseph, MD
role: PRINCIPAL_INVESTIGATOR
References: