Safety and Tolerability Study of MSC Exosome Ointment
Status:
Completed
Trial end date:
2022-04-05
Target enrollment:
Participant gender:
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]