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

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

Completed

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Key information

Conditions

Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Scar Prevention

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chungbuk National University Hospital

Cheongju-si, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LEM-S401

Drug

siRNA encapsulated in DegradaBALL®

Placebo

Drug

Placebo

Primary outcomes

The safety and tolerability of LEM-S401 evaluated by incidence of adverse events

Time frame: Up to 16 days

Evaluation of safety and tolerability of subcutaneous injections of LEM-S401. Examination of any incidence of adverse events.

Sponsors and collaborators

Lead sponsor

Lemonex Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2023
First posted: Jan 13, 2021
Registry last updated: Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed