Status:

COMPLETED

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

Lead Sponsor:

Lemonex Inc.

Conditions:

Cicatrix

Scar Prevention

Eligibility:

All Genders

19-65 years

Phase:

PHASE1

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 sub...

Eligibility Criteria

Inclusion

  • Healthy male and female subjects aged 19 to ≤ 65 years at screening

Exclusion

  • 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

Key Trial Info

Start Date :

July 11 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 3 2023

Estimated Enrollment :

19 Patients enrolled

Trial Details

Trial ID

NCT04707131

Start Date

July 11 2022

End Date

February 3 2023

Last Update

February 16 2023

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Chungbuk National University Hospital

Cheongju-si, South Korea