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

PEP-23-002

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.

2024-07-01

2025-09-30

2025-12-31

Not yet recruiting

Early phase I

9

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.

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2024-05-28