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

Lemonex

Status and phase: Completed; Phase 1

Conditions: Cicatrix; Scar Prevention

Treatments: Drug: Placebo; Drug: LEM-S401

Study type: Interventional

Funder types: Industry

Identifiers

NCT04707131

LEM-S401-101

Details and patient eligibility

About

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

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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19 participants in 2 patient groups, including a placebo group

LEM-S401

Experimental group

Treatment:

Drug: LEM-S401

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo