<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04473859</url>
  </required_header>
  <id_info>
    <org_study_id>ACT1-01</org_study_id>
    <nct_id>NCT04473859</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Safety of FSR Peptide Versus Placebo Following Punch Biopsy</brief_title>
  <official_title>A Phase 1, Double-blind, Single Center, Controlled Study to Evaluate the Safety and Tolerability of FSR Peptide Versus Placebo Following Punch Biopsy in Adult Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xequel Bio, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xequel Bio, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purposes of this study is to test the safety of the study drug (FSR peptide) after a&#xD;
      punch biopsy in healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 6, 2008</start_date>
  <completion_date type="Actual">April 28, 2009</completion_date>
  <primary_completion_date type="Actual">April 28, 2009</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of adverse events</measure>
    <time_frame>Time of consent to day 28</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to healing</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>The wound was clinically evaluated as healed or not healed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of hypertrophic granulation tissue</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>Clinically assessed as present or not present. To qualify as present, there should be at least 3 mm granulation tissue protruding above the edge of the wound at any point of its perimeter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical General Impression scale on the evolution of the wound.</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>Scale of 1-5: 1- Very bad; 2- Bad; 3- Fair; 4- Good; 5- Very Good</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound height</measure>
    <time_frame>day 28</time_frame>
    <description>Assessed using the abbreviated Vancouver Scar Scale. The resulting abbreviated score was as follows. Scores are combined to calculate the final score.&#xD;
Pigmentation 0- Normal. Color that closely resembles the color over the rest of the subject's body&#xD;
Hypopigmentation&#xD;
Hyperpigmentation&#xD;
Vascularity 0- Normal. Color that closely resembles the color over the rest of the subject's body&#xD;
Pink&#xD;
Red&#xD;
Purple</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound pliability</measure>
    <time_frame>day 28</time_frame>
    <description>Assessed using the abbreviated Vancouver Scar Scale. The resulting abbreviated score was as follows. Scores are combined to calculate the final score.&#xD;
Pigmentation 0- Normal. Color that closely resembles the color over the rest of the subject's body&#xD;
Hypopigmentation&#xD;
Hyperpigmentation&#xD;
Vascularity 0- Normal. Color that closely resembles the color over the rest of the subject's body&#xD;
Pink&#xD;
Red&#xD;
Purple</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Histopathological evaluation of the area of the scar tissue</measure>
    <time_frame>day 28</time_frame>
    <description>Performed in a punch biopsy taken from the initial wound site at the end of the 28 day evaluation period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Histopathological evaluation of the epidermal involution</measure>
    <time_frame>day 28</time_frame>
    <description>Performed in a punch biopsy taken from the initial wound site at the end of the 28 day evaluation period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Histopathological evaluation of the rete pegs</measure>
    <time_frame>day 28</time_frame>
    <description>Performed in a punch biopsy taken from the initial wound site at the end of the 28 day evaluation period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Histopathological evaluation of the area of granulation tissue</measure>
    <time_frame>day 28</time_frame>
    <description>Performed in a punch biopsy taken from the initial wound site at the end of the 28 day evaluation period.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Wound Heal</condition>
  <arm_group>
    <arm_group_label>FSR Peptide 20 μM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each subject will have two punch biopsies. FSR peptide will be applied to one punch biopsy. Placebo will be applied to the second punch biopsy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FSR peptide 50 μM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each subject will have two punch biopsies. FSR peptide will be applied to one punch biopsy. Placebo will be applied to the second punch biopsy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FSR peptide 100 μM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each subject will have two punch biopsies. FSR peptide will be applied to one punch biopsy. Placebo will be applied to the second punch biopsy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FSR peptide 200 μM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each subject will have two punch biopsies. FSR peptide will be applied to one punch biopsy. Placebo will be applied to the second punch biopsy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo only</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Each subject will have two punch biopsies. Placebo will be applied to both punch biopsies.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FSR Peptide 20μM</intervention_name>
    <description>Administered immediately after punch-biopsy and 24 hours after punch biopsy.</description>
    <arm_group_label>FSR Peptide 20 μM</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FSR Peptide 50μM</intervention_name>
    <description>Administered immediately after punch-biopsy and 24 hours after punch biopsy.</description>
    <arm_group_label>FSR peptide 50 μM</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FSR Peptide 100μM</intervention_name>
    <description>Administered immediately after punch-biopsy and 24 hours after punch biopsy.</description>
    <arm_group_label>FSR peptide 100 μM</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FSR Peptide 200μM</intervention_name>
    <description>Administered immediately after punch-biopsy and 24 hours after punch biopsy.</description>
    <arm_group_label>FSR peptide 200 μM</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered immediately after punch-biopsy and 24 hours after punch biopsy.</description>
    <arm_group_label>FSR Peptide 20 μM</arm_group_label>
    <arm_group_label>FSR peptide 100 μM</arm_group_label>
    <arm_group_label>FSR peptide 200 μM</arm_group_label>
    <arm_group_label>FSR peptide 50 μM</arm_group_label>
    <arm_group_label>Placebo only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female healthy subjects, 18-45 years of age and in good health as determined&#xD;
             by past medical history, physical examination, vital signs, electrocardiogram, and&#xD;
             laboratory tests at screening.&#xD;
&#xD;
          -  Female subjects must have been surgically sterilized at least six months prior to&#xD;
             screening. Surgical sterilization procedures must be supported with clinical&#xD;
             documentation made available to the sponsor and noted in the Relevant Medical History&#xD;
             / Current Medical Conditions section of the CRF. OR: Postmenopausal women must have no&#xD;
             regular menstrual bleeding for at least two years prior to inclusion. Menopause was to&#xD;
             be confirmed by a plasma 17β-estradiol concentration of &lt;20 pg/mL and a plasma FSH&#xD;
             level of &gt;40 IU/L.&#xD;
&#xD;
          -  Normal sitting blood pressure and pulse rate , i.e.: BP: 100 - 140 mm Hg systolic, 50&#xD;
             - 90 mm Hg diastolic and pulse rate: 45 - 100 bpm. Blood pressure and pulse were to be&#xD;
             measured after 3 minutes resting in a sitting position.&#xD;
&#xD;
          -  Subject body mass index between 18 and 30 kg/m2&#xD;
&#xD;
          -  Ability to communicate well with the investigator and comply with the requirements of&#xD;
             the entire study.&#xD;
&#xD;
          -  The subject has given his written consent to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of serious adverse reactions or hypersensitivity to any drug.&#xD;
&#xD;
          -  Presence or history of any allergy requiring acute or chronic treatment (seasonal)&#xD;
             allergic rhinitis which requires no treatment may be tolerated).&#xD;
&#xD;
          -  History of alcohol or drug abuse in the last 3 years.&#xD;
&#xD;
          -  Abnormal physical findings of clinical significance at the screening examination or&#xD;
             baseline which would interfere with the objectives of the study.&#xD;
&#xD;
          -  Need of any prescription medication within 14 days prior to the administration of the&#xD;
             drug and/or nonprescription medication within 7 days prior to the administration of&#xD;
             the drug or anticipated need for any concomitant medication during the study.&#xD;
&#xD;
          -  Participation in a clinical trial during the previous 4 weeks, i.e. from completion of&#xD;
             the previous trial to the planned first administration of the current trial.&#xD;
&#xD;
          -  Loss of 500 ml blood or more during the 3 month period before the study, e.g. as a&#xD;
             donor.&#xD;
&#xD;
          -  Existence of any surgical or medical condition which might interfere with the&#xD;
             distribution, metabolism or excretion of the drug, i.e. impaired renal or hepatic&#xD;
             function, diabetes mellitus, cardiovascular abnormalities, chronic symptoms of&#xD;
             pronounced constipation or diarrhea or conditions associated with total or partial&#xD;
             obstruction of the urinary tract.&#xD;
&#xD;
        Symptoms of a significant somatic or mental illness in the two week period preceding drug&#xD;
        administration.&#xD;
&#xD;
          -  History of hepatitis B and / or C and / or positive serology results which indicate&#xD;
             the presence of hepatitis B and / or C.&#xD;
&#xD;
          -  Positive results from the HIV serology.&#xD;
&#xD;
          -  Clinically significant abnormal laboratory values (as determined by the Principal&#xD;
             Investigator) at the screening evaluation. Serum albumin below 3.5 g/l (Note to File&#xD;
             no. 8 states that the correct albumin value is below 35g/l) precludes study inclusion&#xD;
             in any case.&#xD;
&#xD;
          -  History of serious mental disorders.&#xD;
&#xD;
          -  Positive results of the drug screening.&#xD;
&#xD;
          -  History or clinical evidence of significant cardiovascular, respiratory, renal,&#xD;
             hepatic, gastrointestinal, hematological, neurologic or other disease.&#xD;
&#xD;
          -  Presence of any active skin pathology including e.g., acne, acute sunburn,&#xD;
             inflammatory skin disease.&#xD;
&#xD;
          -  Presence of any open wounds or infection on the same arm.&#xD;
&#xD;
          -  History of skin disorders e.g. atopic eczema or psoriasis or keloid reaction(s) Any&#xD;
             condition that constitutes a contraindication to minor surgical procedures (such as&#xD;
             bleeding disorders) or that obliges to the use of prophylactic antibiotics (such as&#xD;
             mitral valve prolapse) or other comedications for the performance of minor surgical&#xD;
             procedures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gautam Ghatnekar</last_name>
    <role>Principal Investigator</role>
    <affiliation>CEO</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Swiss Pharma Contract Ltd</name>
      <address>
        <city>Allschwil</city>
        <zip>CH-4123</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>July 16, 2020</last_update_submitted>
  <last_update_submitted_qc>July 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04473859
org study id: ACT1-01
nct id: NCT04473859
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
The purposes of this study is to test the safety of the study drug (FSR peptide) after a
      punch biopsy in healthy subjects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Frequency of adverse events
time frame: Time of consent to day 28
measure: Time to healing
time frame: Up to 28 days
description: The wound was clinically evaluated as healed or not healed.
measure: Presence of hypertrophic granulation tissue
time frame: Up to 28 days
description: Clinically assessed as present or not present. To qualify as present, there should be at least 3 mm granulation tissue protruding above the edge of the wound at any point of its perimeter.
measure: Clinical General Impression scale on the evolution of the wound.
time frame: Up to 28 days
description: Scale of 1-5: 1- Very bad; 2- Bad; 3- Fair; 4- Good; 5- Very Good
measure: Wound height
time frame: day 28
description: Assessed using the abbreviated Vancouver Scar Scale. The resulting abbreviated score was as follows. Scores are combined to calculate the final score.
Pigmentation 0- Normal. Color that closely resembles the color over the rest of the subject's body
Hypopigmentation
Hyperpigmentation
Vascularity 0- Normal. Color that closely resembles the color over the rest of the subject's body
Pink
Red
Purple
measure: Wound pliability
time frame: day 28
description: Assessed using the abbreviated Vancouver Scar Scale. The resulting abbreviated score was as follows. Scores are combined to calculate the final score.
Pigmentation 0- Normal. Color that closely resembles the color over the rest of the subject's body
Hypopigmentation
Hyperpigmentation
Vascularity 0- Normal. Color that closely resembles the color over the rest of the subject's body
Pink
Red
Purple
measure: Histopathological evaluation of the area of the scar tissue
time frame: day 28
description: Performed in a punch biopsy taken from the initial wound site at the end of the 28 day evaluation period.
measure: Histopathological evaluation of the epidermal involution
time frame: day 28
description: Performed in a punch biopsy taken from the initial wound site at the end of the 28 day evaluation period.
measure: Histopathological evaluation of the rete pegs
time frame: day 28
description: Performed in a punch biopsy taken from the initial wound site at the end of the 28 day evaluation period.
measure: Histopathological evaluation of the area of granulation tissue
time frame: day 28
description: Performed in a punch biopsy taken from the initial wound site at the end of the 28 day evaluation period.
arm group label: FSR Peptide 20 μM
arm group type: Experimental
description: Each subject will have two punch biopsies. FSR peptide will be applied to one punch biopsy. Placebo will be applied to the second punch biopsy.
arm group label: FSR peptide 50 μM
arm group type: Experimental
description: Each subject will have two punch biopsies. FSR peptide will be applied to one punch biopsy. Placebo will be applied to the second punch biopsy.
arm group label: FSR peptide 100 μM
arm group type: Experimental
description: Each subject will have two punch biopsies. FSR peptide will be applied to one punch biopsy. Placebo will be applied to the second punch biopsy.
arm group label: FSR peptide 200 μM
arm group type: Experimental
description: Each subject will have two punch biopsies. FSR peptide will be applied to one punch biopsy. Placebo will be applied to the second punch biopsy.
arm group label: Placebo only
arm group type: Placebo Comparator
description: Each subject will have two punch biopsies. Placebo will be applied to both punch biopsies.
intervention type: Drug
intervention name: FSR Peptide 20μM
description: Administered immediately after punch-biopsy and 24 hours after punch biopsy.
arm group label: FSR Peptide 20 μM
intervention type: Drug
intervention name: FSR Peptide 50μM
description: Administered immediately after punch-biopsy and 24 hours after punch biopsy.
arm group label: FSR peptide 50 μM
intervention type: Drug
intervention name: FSR Peptide 100μM
description: Administered immediately after punch-biopsy and 24 hours after punch biopsy.
arm group label: FSR peptide 100 μM
intervention type: Drug
intervention name: FSR Peptide 200μM
description: Administered immediately after punch-biopsy and 24 hours after punch biopsy.
arm group label: FSR peptide 200 μM
intervention type: Drug
intervention name: Placebo
description: Administered immediately after punch-biopsy and 24 hours after punch biopsy.
arm group label: FSR Peptide 20 μM
arm group label: FSR peptide 100 μM
arm group label: FSR peptide 200 μM
arm group label: FSR peptide 50 μM
arm group label: Placebo only
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gautam Ghatnekar
role: Principal Investigator
affiliation: CEO
facility: 
country: Switzerland
responsible party type: Sponsor