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NCT04707131 Clinical Trial

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

Cicatrix Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04707131
Other study ID # LEM-S401-101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date July 11, 2022
Est. completion date February 3, 2023

Study information
Verified date February 2023
Source Lemonex
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 19
Est. completion date February 3, 2023
Est. primary completion date October 18, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• LEM-S401
siRNA encapsulated in DegradaBALL®
• Placebo
Placebo

Locations
Country Name City State
Korea, Republic of Chungbuk National University Hospital Cheongju

Sponsors (1)
Lead Sponsor Collaborator
Lemonex Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary The safety and tolerability of LEM-S401 evaluated by incidence of adverse events Evaluation of safety and tolerability of subcutaneous injections of LEM-S401. Examination of any incidence of adverse events. Up to 16 days
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