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The primary objective of the study is to assess the safety and tolerability of single dose of LEM-S401 in healthy adult subjects.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEM-S401 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEM-S401 | Drug | siRNA encapsulated in DegradaBALL® |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The safety and tolerability of LEM-S401 evaluated by incidence of adverse events | Evaluation of safety and tolerability of subcutaneous injections of LEM-S401. Examination of any incidence of adverse events. | Up to 16 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lemonex Inc. Study Director | Lemonex Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungbuk National University Hospital | Cheongju-si | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40160160 | Derived | Kim HY, Cho J, Park MK, Min DH, Hwang JG, Won C. A First-In-Human Phase 1 Study to Evaluate the Safety and Tolerability of LEM-S401, a Novel siRNA-DegradaBALL Drug Targeting CTGF in Healthy Adults. Clin Transl Sci. 2025 Apr;18(4):e70207. doi: 10.1111/cts.70207. |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Drug |
Placebo |
|