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

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ClinicalTrials.gov Identifier: NCT04707131
Recruitment Status : Not yet recruiting
First Posted : January 13, 2021
Last Update Posted : November 4, 2021
Sponsor:
Information provided by (Responsible Party):
Lemonex ( Lemonex Inc. )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cicatrix Scar Prevention Drug: LEM-S401 Drug: Placebo Phase 1

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : February 2022
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arms and Interventions
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Arm Intervention/treatment
Experimental: LEM-S401 Drug: LEM-S401
siRNA encapsulated in DegradaBALL®
Placebo Comparator: Placebo Drug: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. The safety and tolerability of LEM-S401 evaluated by incidence of adverse events [ Time Frame: Up to 9 days ]
    Evaluation of safety and tolerability of subcutaneous injections of LEM-S401. Examination of any incidence of adverse events.


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Significant history or clinical manifestation of any metabolic, allergic, dermatological (eg, contact dermatitis, atopic dermatitis), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
  • Positive urine drug screen at screening or check-in.
  • If female, pregnant or breastfeeding.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04707131


Locations
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Korea, Republic of
Chungbuk National University Hospital
Cheongju-si, Korea, Republic of
Sponsors and Collaborators
Lemonex Inc.
Investigators
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Study Director: Lemonex Inc. Study Director Lemonex Inc.
More Information
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Responsible Party: Lemonex Inc.
ClinicalTrials.gov Identifier: NCT04707131    
Other Study ID Numbers: LEM-S401-101
First Posted: January 13, 2021    Key Record Dates
Last Update Posted: November 4, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lemonex ( Lemonex Inc. ):
Scars
Scar prevention
Fibrosis
Additional relevant MeSH terms:
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Cicatrix
Fibrosis
Pathologic Processes