Back to resultsA Study of Single Ascending Dose of LEM-S401 in Healthy Participants
Primary Purpose
Cicatrix, Scar Prevention
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
LEM-S401
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cicatrix focused on measuring Scars, Scar prevention, Fibrosis
Eligibility Criteria
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
Sites / Locations
- Chungbuk National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
LEM-S401
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04707131
Brief Title
A Study of Single Ascending Dose of LEM-S401 in Healthy Participants
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 11, 2022 (Actual)
Primary Completion Date
October 18, 2022 (Actual)
Study Completion Date
February 3, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lemonex Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cicatrix, Scar Prevention
Keywords
Scars, Scar prevention, Fibrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LEM-S401
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
LEM-S401
Intervention Description
siRNA encapsulated in DegradaBALL®
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
The safety and tolerability of LEM-S401 evaluated by incidence of adverse events
Description
Evaluation of safety and tolerability of subcutaneous injections of LEM-S401. Examination of any incidence of adverse events.
Time Frame
Up to 16 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lemonex Inc. Study Director
Organizational Affiliation
Lemonex Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Chungbuk National University Hospital
City
Cheongju
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Study of Single Ascending Dose of LEM-S401 in Healthy Participants
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