A Study of Single Ascending Dose of LEM-S401 in Healthy Participants

Lemonex Inc.19 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Cicatrix Scar Prevention

Interventions

LEM-S401DRUG

siRNA encapsulated in DegradaBALL®

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 19 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Chungbuk National University Hospital

Cheongju-si, South Korea

Outcomes

Primary Outcomes

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.

Time frame: Up to 16 days

Data from ClinicalTrials.gov

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