Cicatrix, Scar Prevention
Conditions
Keywords
Scars, Scar prevention, Fibrosis
Brief summary
The primary objective of the study is to assess the safety and tolerability of single dose of LEM-S401 in healthy adult subjects.
Detailed description
This study is designed to evaluate the safety and tolerability of LEM-S401 administered as subcutaneous injection in healthy adult subjects. Overall, 18 subjects will be studied in 3 groups. Each subject will receive LEM-S401 or placebo subcutaneously.
Interventions
DRUGLEM-S401
siRNA encapsulated in DegradaBALL®
DRUGPlacebo
Placebo
Sponsors
Lemonex Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and female subjects aged 19 to ≤ 65 years at screening
Exclusion criteria
* Significant history or clinical manifestation of any hepatic, renal, neurological, psychiatric, respiratory, endocrine, hematological, tumor, genitourinary, cardiovascular, gastrointestinal, musculoskeletal, dermatological (eg, contact dermatitis, atopic dermatitis), or other * History of drug abuse or positive urine drug screen at screening * For all female subjects, pregnant (Urine-HCG positive) or breast-feeding subjects
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The safety and tolerability of LEM-S401 evaluated by incidence of adverse events | Up to 16 days | Evaluation of safety and tolerability of subcutaneous injections of LEM-S401. Examination of any incidence of adverse events. |
Countries
South Korea
Outcome results
None listed