A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Phase I Clinical Trial to Evaluate the Characteristics of the Safety, Tolerability and Pharmacokinetics of LEM-S401 in Healthy Adult Subjects

LEM-S401-101

The primary objective of the study is to assess the safety and tolerability of single dose of LEM-S401 in healthy adult subjects.

2022-07-11

2022-10-18

2023-02-03

Completed

Early phase I

19

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 19, 'type': 'ACTUAL'}}

2023-02-16