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

Phase 1

Completed

• Conditions: Cicatrix; Scar Prevention
• Interventions: Drug: LEM-S401; Drug: Placebo

• Registration Number: NCT04707131
• Lead Sponsor: Lemonex Inc.

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.

Study Timeline

• Study First Submitted: 2021-01-11
• Study First Submitted QC: 2021-01-11
• Study First Posted: 2021-01-13
• Study Start: 2022-07-11
• Primary Completion: 2022-10-18
• Status Verified: 2023-02
• Study Completion: 2023-02-03
• Last Update Submitted: 2023-02-14
• Last Update Posted: 2023-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LEM-S401	LEM-S401	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Chungbuk National University Hospital; 🇰🇷 Cheongju, Korea, Republic of