NCT04707131

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2022

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2021

Completed
1.5 years until next milestone

Study Start

First participant enrolled

July 11, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2023

Completed
Last Updated

February 16, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

January 11, 2021

Last Update Submit

February 14, 2023

Conditions

CicatrixScar Prevention

Keywords

ScarsScar preventionFibrosis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

LEM-S401

EXPERIMENTAL
Drug: LEM-S401

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

LEM-S401DRUG

siRNA encapsulated in DegradaBALL®

LEM-S401
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chungbuk National University Hospital

Cheongju-si, South Korea

Location

Related Publications (1)

  • Kim HY, Cho J, Park MK, Min DH, Hwang JG, Won C. A First-In-Human Phase 1 Study to Evaluate the Safety and Tolerability of LEM-S401, a Novel siRNA-DegradaBALL Drug Targeting CTGF in Healthy Adults. Clin Transl Sci. 2025 Apr;18(4):e70207. doi: 10.1111/cts.70207.

    PMID: 40160160DERIVED

MeSH Terms

Conditions

CicatrixFibrosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lemonex Inc. Study Director

    Lemonex Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2021

First Posted

January 13, 2021

Study Start

July 11, 2022

Primary Completion

October 18, 2022

Study Completion

February 3, 2023

Last Updated

February 16, 2023

Record last verified: 2023-02

Locations

KR(1)