CicatrixPhase 1NCT04707131
A Study of Single Ascending Dose of LEM-S401 in Healthy Participants
A Phase 1 study testing LEM-S401 in people with Cicatrix and Scar Prevention, run by Lemonex Inc. at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cicatrix, Scar Prevention
- What is being tested?
- LEM-S401
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Jul 2022to 3 Feb 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and female subjects aged 19 to ≤ 65 years at screening
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
The primary objective of the study is to assess the safety and tolerability of single dose of LEM-S401 in healthy adult subjects.
Read the 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.
- Conditions
- Cicatrix, Scar Prevention
- Being tested
- LEM-S401, Placebo
- Keywords
- Scars, Scar prevention, Fibrosis
- Medical subject headings
- Cicatrix, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEM-S401Drug
siRNA encapsulated in DegradaBALL®
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| LEM-S401 | Experimental | Not described Receives: Drug: LEM-S401 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start11 Jul 2022
- Primary completion18 Oct 2022
- Study completion3 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CicatrixStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lemonex Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lemonex Inc. Study Director, Study director, Lemonex Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04707131
- Sponsor's protocol ID
- LEM-S401-101
- Status last verified
- Feb 2023
- First submitted
- 11 Jan 2021
- Last updated
- 16 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40160160
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04707131
- Acronym / sponsor ID
- LEM-S401-101
- Conditions
- Cicatrix, Scar Prevention
- Keywords
- Scars, Scar prevention, Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Lemonex Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- 18 Oct 2022 (actual)
- Study completion
- 3 Feb 2023 (actual)
- First posted
- 13 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LEM-S401 | Experimental | Drug: LEM-S401 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy male and female subjects aged 19 to ≤ 65 years at screening
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LEM-S401siRNA encapsulated in DegradaBALL® | Drug | LEM-S401 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Derived from this study: PubMed 40160160Kim 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lemonex Inc. Study Director study director
Lemonex Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LEM-S401 in people with Cicatrix and Scar Prevention, run by Lemonex Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety and tolerability of LEM-S401 evaluated by incidence of adverse events (time frame: Up to 16 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04707131, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.