<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/NCT03772678</url>
  </required_header>
  <id_info>
    <org_study_id>AB001</org_study_id>
    <nct_id>NCT03772678</nct_id>
  </id_info>
  <brief_title>A Phase I Study to Evaluate LSALT Peptide</brief_title>
  <official_title>A Phase I Double-blind, Placebo-controlled, Randomized, Single and Multiple Ascending Dose Finding Study to Evaluate the Safety and Pharmacokinetic Profile of LSALT Peptide in Healthy Participants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Arch Biopartners Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Arch Biopartners Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A phase I double-blind, placebo-controlled, randomized, single and multiple ascending dose&#xD;
      finding study to evaluate the safety and pharmacokinetic profile of LSALT peptide in healthy&#xD;
      participants&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 27, 2019</start_date>
  <completion_date type="Actual">March 31, 2020</completion_date>
  <primary_completion_date type="Actual">March 31, 2020</primary_completion_date>
  <phase>Early 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>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Pharmacist not blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Low Dose SAD - Adverse events</measure>
    <time_frame>Within 4 days</time_frame>
    <description>NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SAD - Adverse Events</measure>
    <time_frame>Within 7 days</time_frame>
    <description>NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MAD - Adverse Events</measure>
    <time_frame>Within 21 days</time_frame>
    <description>NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>None - Study is to Determine Safety in Healthy Participants</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>0.9% Saline For SAD and MAD arms.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Single Ascending Dose - Low Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LSALT peptide (1mg/mL in 0.9% saline) Single escalating dose - 0.01mg, 0.1mg, 0.3mg, 0.5mg intravenously Escalation to 2.5mg and 5mg doses in next cohorts if no adverse effects are seen after 10-14 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Single Ascending Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LSALT peptide (1mg/mL in 0.9% saline) Single dose - 1mg intravenously over 2h Escalation to next dose in next participant every 72h if no adverse effects are seen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple Ascending Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LSALT peptide (1mg/mL in 0.9% saline) Dose will be determined based on results of SAD arm. LSALT will be administered intravenously once or twice daily for 3 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LSALT peptide</intervention_name>
    <description>novel 16 amino acid peptide</description>
    <arm_group_label>Multiple Ascending Dose</arm_group_label>
    <arm_group_label>Single Ascending Dose</arm_group_label>
    <arm_group_label>Single Ascending Dose - Low Dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>0.9% Saline</intervention_name>
    <description>saline</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  No prior history of major organ or systemic disease including diabetes, hypertension,&#xD;
             kidney, heart or liver disease. Participants with childhood asthma are acceptable.&#xD;
&#xD;
          -  Normal hematology, clinical chemistry and urinalysis parameters at screening, unless&#xD;
             not deemed clinically significant by the investigator.&#xD;
&#xD;
          -  Body Mass Index (BMI) between 18 kg/m2 and 32 kg/m2 (inclusive)&#xD;
&#xD;
          -  Taking no prescription medications 2 weeks prior to admission or over-the-counter&#xD;
             medications 7 days prior to admission. Occasional use of paracetamol or ibuprofen (up&#xD;
             to 1000 mg and 400 mg/day respectively) are acceptable. Routine vitamins and&#xD;
             supplements are permissible at the discretion of the investigator.&#xD;
&#xD;
          -  Able to allow intravenous medication to be administered.&#xD;
&#xD;
          -  Males (along with their female partners) and females of childbearing potential&#xD;
             (defined as a female who is not menopausal or surgically sterilized) must be willing&#xD;
             to use an acceptable method of birth control during heterosexual activities including&#xD;
             a condom and a second highly effective method (i.e., hormonal contraceptive,&#xD;
             intra-uterine device) or abstinence for the duration of the study. Should a woman&#xD;
             become pregnant or suspect she is pregnant while participating in this study, she must&#xD;
             inform her treating physician immediately. Males should continue with the&#xD;
             aforementioned contraception for 90 days after the last dose and females should&#xD;
             continue with the aforementioned contraception for 60 days after last dose.&#xD;
&#xD;
          -  Able to understand and willing to sign an ethics committee-approved written informed&#xD;
             consent document&#xD;
&#xD;
          -  Non-smokers. Social and light smokers of up to 10 cigarettes per day who can abstain&#xD;
             from smoking during the confinement period and have no evidence of underlying lung&#xD;
             disease (bronchitis, COPD or reactive airways disease).&#xD;
&#xD;
          -  Willing to remain abstinent from alcohol 24 hours prior to admission and until after&#xD;
             the confinement period in the unit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A history of cardiovascular disease, diabetes or hypertension (&gt;150/90 after 5 minutes&#xD;
             sitting), significant neurological, pulmonary (including asthma), hepatic, rheumatic,&#xD;
             autoimmune, haematological, metabolic or renal disorder.&#xD;
&#xD;
          -  Prescription medications are prohibited. No prescription medications 2 weeks prior to&#xD;
             admission or over-the-counter medications 7 days prior to admission. Occasional use of&#xD;
             paracetamol or ibuprofen (up to 1000 mg and 400 mg/day respectively) are acceptable.&#xD;
             Routine vitamins and supplements are permissible at the discretion of the&#xD;
             investigator.&#xD;
&#xD;
          -  Any moderate or severe allergies, including anaphylaxis, to food, drugs or&#xD;
             environmental allergens. Mild allergies such as hayfever may be included.&#xD;
&#xD;
          -  Females who are pregnant or lactating. Women of childbearing potential must have a&#xD;
             negative pregnancy test within 14 days of study initiation and at baseline.&#xD;
&#xD;
          -  Consumption of caffeine 48 hours prior to start of study treatment and whilst confined&#xD;
             to the unit.&#xD;
&#xD;
          -  History of any psychiatric illness or psychological disorder which may impair the&#xD;
             ability to provide written informed consent or participate in the study&#xD;
&#xD;
          -  Clinically significant abnormal laboratory value at screening as determined by the&#xD;
             Investigator.&#xD;
&#xD;
          -  Participant is sero-positive to HIV-1 or HIV-2, HCV or HBV.&#xD;
&#xD;
          -  History or presence of alcoholism within two years prior to the first study drug&#xD;
             administration or drugs of abuse unless it can be explained to the satisfaction of the&#xD;
             investigator that it is due to a standard dose of a prescribed medication and that an&#xD;
             adequate wash-out will occur prior to admission.&#xD;
&#xD;
          -  No findings on clinical examination that, in the opinion of the investigator, could&#xD;
             compromise the safety of the participant or the results of the study.&#xD;
&#xD;
          -  Blood donation or significant blood loss within 60 days prior to the first study drug&#xD;
             administration.&#xD;
&#xD;
          -  Administration of investigational product in another trial within 30 days prior to the&#xD;
             first study drug administration or five half-lives, whichever is longer.&#xD;
&#xD;
          -  Surgery within the past 3 months prior to the first study drug administration&#xD;
             determined by the PI to be clinically relevant.&#xD;
&#xD;
          -  Active malignancy or history of malignancy in the past 5 years.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Nucleus Network Ltd.</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 9, 2018</study_first_submitted>
  <study_first_submitted_qc>December 9, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>June 16, 2020</last_update_submitted>
  <last_update_submitted_qc>June 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>May 17, 2022</submitted>
    <returned>February 22, 2023</returned>
  </pending_results>
  <!-- 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/NCT03772678
org study id: AB001
nct id: NCT03772678
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A phase I double-blind, placebo-controlled, randomized, single and multiple ascending dose
      finding study to evaluate the safety and pharmacokinetic profile of LSALT peptide in healthy
      participants
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Pharmacist not blind
measure: Low Dose SAD - Adverse events
time frame: Within 4 days
description: NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0
measure: SAD - Adverse Events
time frame: Within 7 days
description: NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0
measure: MAD - Adverse Events
time frame: Within 21 days
description: NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0
arm group label: Placebo
arm group type: Placebo Comparator
description: 0.9% Saline For SAD and MAD arms.
arm group label: Single Ascending Dose - Low Dose
arm group type: Experimental
description: LSALT peptide (1mg/mL in 0.9% saline) Single escalating dose - 0.01mg, 0.1mg, 0.3mg, 0.5mg intravenously Escalation to 2.5mg and 5mg doses in next cohorts if no adverse effects are seen after 10-14 days.
arm group label: Single Ascending Dose
arm group type: Experimental
description: LSALT peptide (1mg/mL in 0.9% saline) Single dose - 1mg intravenously over 2h Escalation to next dose in next participant every 72h if no adverse effects are seen.
arm group label: Multiple Ascending Dose
arm group type: Experimental
description: LSALT peptide (1mg/mL in 0.9% saline) Dose will be determined based on results of SAD arm. LSALT will be administered intravenously once or twice daily for 3 days.
intervention type: Drug
intervention name: LSALT peptide
description: novel 16 amino acid peptide
arm group label: Multiple Ascending Dose
arm group label: Single Ascending Dose
arm group label: Single Ascending Dose - Low Dose
intervention type: Other
intervention name: 0.9% Saline
description: saline
arm group label: Placebo
criteria: 
gender: All
gender based: Yes
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Australia
responsible party type: Sponsor
sharing ipd: No
submitted: May 17, 2022
returned: February 22, 2023