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Safety, Tolerability, Pharmacokinetics, Immunogenicity and Efficacy of STP705 in Adult Patients With Hypertrophic Scars

Primary Purpose

Hypertrophic Scar

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
STP705
Sponsored by
Sirnaomics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertrophic Scar

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female adult ≥ 18 and ≤ 45 years old at the time of signing the ICF,
  2. Diagnosed with hypertrophic scars, with all the following characteristics:

    1. Linear hypertrophic scar, with a width of 0.3-1.0 cm and a length of ≥10 cm;
    2. Scars with any of the following characteristics: redness or purpleness, stiffness, rough surface, significant swelling, visible dilated capillaries on the surface, and possibly accompanied by pain or itching;
    3. The course of the disease is 6 to 24 months (inclusive);
    4. Scars are not located on the face, front of the neck, feet, hands, knees, elbows or any joints;
  3. The examination during the screening period must meet the following criteria: medical history, physical examination (excluding hypertrophic scar), 12-lead ECG, vital signs, laboratory examinations are judged by the investigator to meet the requirements, and no clinically significant abnormalities were observed;
  4. Subjects of childbearing potential (male or female) must take effective medical contraceptive measures during the study and within 6 months after the end of administration;
  5. Subjects voluntarily participate in this clinical trial and sign the ICF, can understand and comply with the study procedures, and complete the entire study as specified by the protocol.

Exclusion Criteria:

  1. Diagnosed with keloid or burn scar;
  2. Positive in hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus (HIV), or syphilis antibody tests;
  3. Medication history of corticosteroids use (including inhaled steroids, triamcinolone acetonide, etc.) and COX-2 inhibitors within 3 months before the first injection of the study (if 5 times the half-life is longer than 3 months, then 5 times the half-life will prevail);
  4. Impaired immune function (such as cancer, or other diseases that affect the basic immune responses);
  5. Concomitant diseases that is uncontrolled or poorly controlled or may affect the study, including clinically important cardiovascular, lung, kidney, endocrine, liver, nerve, mental, immune, gastrointestinal, blood, urogenital, skeletal or metabolic disorders at the investigator's discretion;
  6. Known to be allergic to STP705 or any components of its prescription;
  7. Having difficulty in venous blood collection, or having a history of needle fainting or blood fainting;
  8. Infection or trauma in the site to be treated;
  9. Pregnant and lactating women;
  10. Participated in other clinical studies and received treatment within 3 months before the first injection;
  11. Blood donation or blood loss ≥400 mL within 3 months before the first injection (except for female blood loss during menstrual period), or planning to donate blood or blood components during the study period or within 3 months after the end of the study;
  12. History of drug abuse/dependence or drug history or positive in drug abuse screening (screening items can include: morphine, tetrahydrocannabinol acid, methamphetamine, methylenedioxy methanphetamine, ketamine and cocaine) within 1 year before the first injection;
  13. Medication history of any drugs (including prescription drugs, over-the-counter drugs, Chinese herbal medicines, etc.) or health care products within 14 days before the first injection;
  14. Vaccinated with live vaccines within 4 weeks before the first injection or planning to receive live vaccines within 4 weeks after the last dose. Live vaccines include but not limited to: measles, mumps, rubella, chickenpox, yellow fever, rabies, Bacillus Calmette-Guerin, typhoid fever, COVID-19 live vaccines, etc.;
  15. Any surgical, medical or laboratory pathophysiological conditions that may interfere with the safety, distribution, metabolism or excretion of the investigational drug at the discretion of the investigator;
  16. Unable to communicate or cooperate with medical staff due to neurological, mental disorders or language/ verbal communication issues;
  17. Other situations not suitable for participation in the study as judged by the investigator.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Part 1: Group 1

    Part 1: Group 2

    Part 1: Group 3

    Part 1: Group 4

    Part 1: Group 5

    Part 1: Group 6

    Arm Description

    10ug Intrascar injection

    20ug Intrascar injection

    40ug Intrascar injection

    60ug Intrascar injection

    80ug Intrascar injection

    100ug Intrascar injection

    Outcomes

    Primary Outcome Measures

    Concentration of siRNA-TGF-B1 and siRNA-COX-2 in serum
    siRNA-TGF-B1 and siRNA-COX-2 and HKP will be calculated

    Secondary Outcome Measures

    Change of the scar from baseline using Observer Scar Assessment Scale
    The scale will be used to record: vascularity, pigmentation, thickness, releif, pliability, surface area of the scar where 1= Normal skin and 10 = the worst case.
    Change of the scar from baseline using Patient scale
    The scale will be used to record: pain, itching, color, hardness, thickness, and relief where 1= No, not different from normal and 10 = Yes, very different from normal.

    Full Information

    First Posted
    December 15, 2021
    Last Updated
    February 28, 2023
    Sponsor
    Sirnaomics
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05196373
    Brief Title
    Safety, Tolerability, Pharmacokinetics, Immunogenicity and Efficacy of STP705 in Adult Patients With Hypertrophic Scars
    Official Title
    A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of STP705 Administered as Intrascar Injection in Adult Patients With Hypertrophic Scars
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sirnaomics

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Adult patients with hypertrophic scars 30 Subjects in Dose Escalation 20 Subjects in Dose Expansion Intrascar injection of STP705 weekly for 4 weeks
    Detailed Description
    An open label study design to evaluate the preliminary efficacy of STP705 in adult patients with hypertrophic scars. The study is divided into 2 stages: 1. Dose Escalation: 30 subjects to be enrolled in this stage with a total of 6 dose groups. 3 subjects will be enrolled in 10ug and 20ug groups and 6 subjects in the subsequent groups of 40ug, 60ug, 80u and 100ug. 2. Dose Expansion:1-2 dose groups will be selected and 20 subjects will be enrolled in each group.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertrophic Scar

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Sequential Assignment
    Model Description
    Open label, Dose Escalation and Dose Expansion
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Part 1: Group 1
    Arm Type
    Experimental
    Arm Description
    10ug Intrascar injection
    Arm Title
    Part 1: Group 2
    Arm Type
    Experimental
    Arm Description
    20ug Intrascar injection
    Arm Title
    Part 1: Group 3
    Arm Type
    Experimental
    Arm Description
    40ug Intrascar injection
    Arm Title
    Part 1: Group 4
    Arm Type
    Experimental
    Arm Description
    60ug Intrascar injection
    Arm Title
    Part 1: Group 5
    Arm Type
    Experimental
    Arm Description
    80ug Intrascar injection
    Arm Title
    Part 1: Group 6
    Arm Type
    Experimental
    Arm Description
    100ug Intrascar injection
    Intervention Type
    Drug
    Intervention Name(s)
    STP705
    Intervention Description
    STP705 Powder for Injection composed of siRNA-TGF-B1 and siRNA-COX-2 packged in a proprietary polymer nanoparticle formulation for delivery.
    Primary Outcome Measure Information:
    Title
    Concentration of siRNA-TGF-B1 and siRNA-COX-2 in serum
    Description
    siRNA-TGF-B1 and siRNA-COX-2 and HKP will be calculated
    Time Frame
    7 weeks
    Secondary Outcome Measure Information:
    Title
    Change of the scar from baseline using Observer Scar Assessment Scale
    Description
    The scale will be used to record: vascularity, pigmentation, thickness, releif, pliability, surface area of the scar where 1= Normal skin and 10 = the worst case.
    Time Frame
    7 weeks
    Title
    Change of the scar from baseline using Patient scale
    Description
    The scale will be used to record: pain, itching, color, hardness, thickness, and relief where 1= No, not different from normal and 10 = Yes, very different from normal.
    Time Frame
    7 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female adult ≥ 18 and ≤ 45 years old at the time of signing the ICF, Diagnosed with hypertrophic scars, with all the following characteristics: Linear hypertrophic scar, with a width of 0.3-1.0 cm and a length of ≥10 cm; Scars with any of the following characteristics: redness or purpleness, stiffness, rough surface, significant swelling, visible dilated capillaries on the surface, and possibly accompanied by pain or itching; The course of the disease is 6 to 24 months (inclusive); Scars are not located on the face, front of the neck, feet, hands, knees, elbows or any joints; The examination during the screening period must meet the following criteria: medical history, physical examination (excluding hypertrophic scar), 12-lead ECG, vital signs, laboratory examinations are judged by the investigator to meet the requirements, and no clinically significant abnormalities were observed; Subjects of childbearing potential (male or female) must take effective medical contraceptive measures during the study and within 6 months after the end of administration; Subjects voluntarily participate in this clinical trial and sign the ICF, can understand and comply with the study procedures, and complete the entire study as specified by the protocol. Exclusion Criteria: Diagnosed with keloid or burn scar; Positive in hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus (HIV), or syphilis antibody tests; Medication history of corticosteroids use (including inhaled steroids, triamcinolone acetonide, etc.) and COX-2 inhibitors within 3 months before the first injection of the study (if 5 times the half-life is longer than 3 months, then 5 times the half-life will prevail); Impaired immune function (such as cancer, or other diseases that affect the basic immune responses); Concomitant diseases that is uncontrolled or poorly controlled or may affect the study, including clinically important cardiovascular, lung, kidney, endocrine, liver, nerve, mental, immune, gastrointestinal, blood, urogenital, skeletal or metabolic disorders at the investigator's discretion; Known to be allergic to STP705 or any components of its prescription; Having difficulty in venous blood collection, or having a history of needle fainting or blood fainting; Infection or trauma in the site to be treated; Pregnant and lactating women; Participated in other clinical studies and received treatment within 3 months before the first injection; Blood donation or blood loss ≥400 mL within 3 months before the first injection (except for female blood loss during menstrual period), or planning to donate blood or blood components during the study period or within 3 months after the end of the study; History of drug abuse/dependence or drug history or positive in drug abuse screening (screening items can include: morphine, tetrahydrocannabinol acid, methamphetamine, methylenedioxy methanphetamine, ketamine and cocaine) within 1 year before the first injection; Medication history of any drugs (including prescription drugs, over-the-counter drugs, Chinese herbal medicines, etc.) or health care products within 14 days before the first injection; Vaccinated with live vaccines within 4 weeks before the first injection or planning to receive live vaccines within 4 weeks after the last dose. Live vaccines include but not limited to: measles, mumps, rubella, chickenpox, yellow fever, rabies, Bacillus Calmette-Guerin, typhoid fever, COVID-19 live vaccines, etc.; Any surgical, medical or laboratory pathophysiological conditions that may interfere with the safety, distribution, metabolism or excretion of the investigational drug at the discretion of the investigator; Unable to communicate or cooperate with medical staff due to neurological, mental disorders or language/ verbal communication issues; Other situations not suitable for participation in the study as judged by the investigator.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    nadia sheibani
    Phone
    301-740-1730
    Email
    nadiasheibani@sirnaomics.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Safety, Tolerability, Pharmacokinetics, Immunogenicity and Efficacy of STP705 in Adult Patients With Hypertrophic Scars

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