Safety and Tolerability Study of MSC Exosome Ointment

• Status: Completed
• Trial end date: 2022-04-05
• Target enrollment: 0
• Participant gender: All

Summary

This phase 1 study aims to evaluate the safety and tolerability of the application of the MSC exosome ointment with repeated topical application on adult healthy subjects (TID from Day 1 to 20). The results of this study were to provide the first clinical information on the drug's safety and inform the selection of administration of exosome ointment to be evaluated in subsequent clinical studies. The endpoints included to assess the safety and tolerability of exosome ointment for topical application in healthy adult volunteers are:

• Frequency of treatment-emergent adverse events (TEAEs)

• The incidence rate of local skin responses (LSR, i.e., erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration, hyperpigmentation, hypopigmentation, and scarring) [Time Frame: Days 1 and 21]

• Changes from baseline in blood parameters (including hematology, chemistry, and other inflammation parameters such as C-reactive protein [CRP] and erythrocyte sedimentation rate [ESR]) [Time Frame: Days 1 and 21]

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Paracrine Therapeutics Dermatology Pte. Ltd.
• Collaborator: National University Hospital, Singapore

Criteria

Inclusion Criteria:

1. Signed ICF prior to entering the study or undergoing any study procedures.

2. Male or female, >21 years of age at the time of signing the informed consent.

3. Subject who had been fully vaccinated for COVID-19 and was not under quarantine or Stay Home Notice or on medical leave.

4. Subject who was willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

5. Subject was able to read and write in the English language.

6. For women who were not postmenopausal (> 12 months of non-therapy induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus):

1. had a negative pregnancy test at screening

2. remained abstinent or used contraceptive methods during the treatment period and continued for at least 30 days (one menstrual cycle) after the last treatment dose.

Exclusion Criteria:

1. Subject had any serious skin condition that was not well controlled.

2. Subject was currently using topical treatments.

3. Pregnant or breast-feeding women.

4. Subject had received phototherapy, oral corticosteroids, oral retinoid, oral immunosuppressive / immune modulative drugs, cytostatic / cytotoxic drugs, cyclosporine, or methotrexate within 30 days prior to the first application of the study product.

5. Subject was currently using any medications including biologics or undergoing treatment known to affect skin conditions.

6. Subject had any other clinically significant laboratory abnormalities, co-morbidities or psychiatric conditions that would place the subject at increased risk or confound the objectives of the study.

7. Subject had used any investigational drugs or biologics and/or participated in any clinical trial within the last 60 days before the day of the first dose of the study drug or was taking part in a non-medication study that would interfere with study compliance or outcome assessments.