xml: <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/NCT05965089</url>
    </required_header>
    <id_info>
      <org_study_id>AX-202-01</org_study_id>
      <nct_id>NCT05965089</nct_id>
    </id_info>
    <brief_title>A First in Human Study of AX-202 in Healthy Subjects and Patients With Psoriasis.</brief_title>
    <official_title>A First-in-human, Randomised Double-blind, Placebo-controlled 2-part Study to Evaluate the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Single Ascending Doses of AX-202 in Healthy Subjects and Multiple Ascending Doses of AX-202 in Patients With Mild to Moderate Chronic Plaque Psoriasis.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Arxx Therapeutics</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Arxx Therapeutics</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>
        The first-in-human study will be performed in healthy volunteers and patients with a chronic&#xD;
        inflammatory skin disease. The primary objective is to evaluate the safety, tolerability and&#xD;
        pharmacokinetics of increasing doses of AX-202 infusion.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 25, 2023</start_date>
    <completion_date type="Anticipated">April 4, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 4, 2024</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>
      <intervention_model_description>Single-ascending doses in healthy subjects and multiple ascending doses in patients with mild to moderate chronic plaque psoriasis</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
      <masking_description>Double blind</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>To assess the safety and tolerability of a single ascending IV dose of AX-202 in healthy subjects and multiple ascending IV doses of AX-202 in patients with mild to moderate chronic plaque psoriasis by monitoring of adverse events.</measure>
      <time_frame>Until 100 days after last dose</time_frame>
      <description>Number of patients with AE's</description>
    </primary_outcome>
    <primary_outcome>
      <measure>To assess the safety and tolerability of a single ascending IV dose of AX-202 in healthy subjects and multiple ascending IV doses of AX-202 in patients with mild to moderate chronic plaque psoriasis by physical examinations.</measure>
      <time_frame>Until 100 days after last dose</time_frame>
      <description>Number of patients with clinically significant findings on physical examinations</description>
    </primary_outcome>
    <primary_outcome>
      <measure>To assess the safety and tolerability of a single ascending IV dose of AX-202 in healthy subjects and multiple ascending IV doses of AX-202 in patients with mild to moderate chronic plaque psoriasis by assessment of infusion related reactions</measure>
      <time_frame>Until 100 days after last dose</time_frame>
      <description>Number of patients with infusion related reactions</description>
    </primary_outcome>
    <primary_outcome>
      <measure>To assess the safety and tolerability of a single ascending IV dose of AX-202 in healthy subjects and multiple ascending IV doses of AX-202 in patients with mild to moderate chronic plaque psoriasis by monitoring of vital signs</measure>
      <time_frame>Until 100 days after last dose</time_frame>
      <description>Number of patients with clinically significant changes from baseline in vital signs</description>
    </primary_outcome>
    <primary_outcome>
      <measure>To assess the safety and tolerability of a single ascending IV dose of AX-202 in healthy subjects and multiple ascending IV doses of AX-202 in patients with mild to moderate chronic plaque psoriasis by monitoring of clinical laboratory parameters</measure>
      <time_frame>Until 100 days after last dose</time_frame>
      <description>Number of patients with clinically significant change from baseline in clinical laboratory test results.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>To assess the safety and tolerability of a single ascending IV dose of AX-202 in healthy subjects and multiple ascending IV doses of AX-202 in patients with mild to moderate chronic plaque psoriasis by ECG monitoring</measure>
      <time_frame>Until 100 days after last dose</time_frame>
      <description>Number of patients with clinically significant change from baseline in ECG parameters</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>To characterise systemic PK of AX-202 after a single ascending IV dose in healthy subjects and after multiple ascending IV doses in patients with mild to moderate chronic plaque psoriasis.</measure>
      <time_frame>Until 100 days after last dose</time_frame>
      <description>Calculation of maximum serum concentration (Cmax) of AX-202</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To characterise systemic PK of AX-202 after a single ascending IV dose in healthy subjects and after multiple ascending IV doses in patients with mild to moderate chronic plaque psoriasis.</measure>
      <time_frame>Until 100 days after last dose</time_frame>
      <description>Calculation of time to maximum concentration (tmax) of AX-202</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To characterise systemic PK of AX-202 after a single ascending IV dose in healthy subjects and after multiple ascending IV doses in patients with mild to moderate chronic plaque psoriasis.</measure>
      <time_frame>Until 100 days after last dose</time_frame>
      <description>Calculation of the area under the plasma concentration-time curve (AUC)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To characterise systemic PK of AX-202 after a single ascending IV dose in healthy subjects and after multiple ascending IV doses in patients with mild to moderate chronic plaque psoriasis.</measure>
      <time_frame>Until 100 days after last dose</time_frame>
      <description>Calculation of the half-life of AX-202</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To characterise systemic PK of AX-202 after a single ascending IV dose in healthy subjects and after multiple ascending IV doses in patients with mild to moderate chronic plaque psoriasis.</measure>
      <time_frame>Until 100 days after last dose</time_frame>
      <description>Calculation of the clearance (CL) of AX-202</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To characterise systemic PK of AX-202 after a single ascending IV dose in healthy subjects and after multiple ascending IV doses in patients with mild to moderate chronic plaque psoriasis.</measure>
      <time_frame>Until 100 days after last dose</time_frame>
      <description>Calculation of volume of distribution at steady state (Vss)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To evaluate immunogenicity of AX-202 after a single ascending IV dose in healthy subjects and after multiple ascending IV doses in patients with mild to moderate chronic plaque psoriasis.</measure>
      <time_frame>Until 100 days after last dose</time_frame>
      <description>Number of participants with anti-drug antibodies against AX-202</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">58</enrollment>
    <condition>Healthy Volunteers</condition>
    <condition>Mild to Moderate Psoriasis</condition>
    <arm_group>
      <arm_group_label>AX-202</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Single and multiple ascending doses of AX-202</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Single and multiple doses of placebo</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>AX-202</intervention_name>
      <description>Humanized monoclonal antibody</description>
      <arm_group_label>AX-202</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Key Inclusion Criteria:&#xD;
  &#xD;
          Part A / Single ascending doses:&#xD;
  &#xD;
            -  Male and female subjects must be between 18-55 years inclusive, at the time of&#xD;
               informed consent.&#xD;
  &#xD;
            -  Subjects must have a Body Mass Index (BMI) ≥ 18 and ≤ 32 kg/m2 and weight of at least&#xD;
               45kg at screening.&#xD;
  &#xD;
            -  Subjects must be in good health as determined by medical history, physical&#xD;
               examination, vital signs, 12-lead ECG and clinical laboratory assessments at the time&#xD;
               of screening, as judged by the Investigator.&#xD;
  &#xD;
          Part B / Multiple ascending doses:&#xD;
  &#xD;
            -  Male and female patients must be between 18-65 years inclusive, at the time of&#xD;
               informed consent.&#xD;
  &#xD;
            -  Patients must have a documented diagnosis of plaque psoriasis for ≥ 6 months prior to&#xD;
               screening.&#xD;
  &#xD;
            -  Patients must have a Body Mass Index (BMI) ≥ 18 and ≤ 36 kg/m2 and weigh at least 45kg&#xD;
               at screening.&#xD;
  &#xD;
            -  Patients must be in good health as determined by medical history, physical&#xD;
               examination, vital signs, 12-lead ECG and clinical laboratory assessments at the time&#xD;
               of screening, as judged by the Investigator.&#xD;
  &#xD;
          Key Exclusion Criteria:&#xD;
  &#xD;
          Part A / Single ascending doses:&#xD;
  &#xD;
            -  History or presence of any clinically relevant acute or chronic medical or psychiatric&#xD;
               condition that could interfere with the subject's safety during the clinical study or&#xD;
               expose the subject to undue risk as judged by the Investigator.&#xD;
  &#xD;
            -  After a minimum of 10 minutes supine rest at the time of screening or on Day -1:&#xD;
  &#xD;
                 -  Systolic blood pressure &lt;90 or &gt;140 mmHg, or&#xD;
  &#xD;
                 -  Diastolic blood pressure &lt;50 or &gt;90 mmHg, or&#xD;
  &#xD;
                 -  Pulse &lt;40 or &gt;90 bpm&#xD;
  &#xD;
            -  Any clinically significant abnormalities in resting ECG at the time of screening or on&#xD;
               Day -1 including prolonged QTcF (&gt;450 ms for males; &gt;470 ms for females using the mean&#xD;
               of triplicate ECGs) and cardiac arrhythmias, as judged by the Investigator.&#xD;
  &#xD;
            -  Clinically significant abnormalities in renal function at screening.&#xD;
  &#xD;
            -  Clinically significant abnormalities in liver function at screening.&#xD;
  &#xD;
            -  Haemoglobin &lt; 130 g/l for males or &lt;120 g/l for females at screening.&#xD;
  &#xD;
            -  Any clinically significant illness, medical/surgical procedure or trauma within 4&#xD;
               weeks of the first administration of IMP (Day 1).&#xD;
  &#xD;
            -  Malignancy within the past 5 years of screening with the exception of in situ removal&#xD;
               of basal cell carcinoma or resected benign colonic polyps.&#xD;
  &#xD;
            -  Any planned major surgery within the duration of the study or in the 30 days following&#xD;
               study completion.&#xD;
  &#xD;
            -  History of latent or active tuberculosis or a positive QuantiFERON® TB Gold test at&#xD;
               screening.&#xD;
  &#xD;
            -  Females who are pregnant, breast feeding, lactating or plan to be pregnant during the&#xD;
               study period or 120 days after.&#xD;
  &#xD;
            -  Female subjects with a positive serum or urine pregnancy test (minimum sensitivity 25&#xD;
               IU/L or equivalent units of human chorionic gonadotropin [HCG]) at screening or on Day&#xD;
               -1.&#xD;
  &#xD;
            -  Positive serum hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies&#xD;
               (HCVAb) or human immunodeficiency virus (HIV) 1 and/or 2 antibodies at screening.&#xD;
  &#xD;
            -  A Positive test for active COVID -19 prior to dosing on Day 1.&#xD;
  &#xD;
            -  History of any drug and/or alcohol abuse in the past 2 years prior to screening.&#xD;
  &#xD;
            -  Regular alcohol consumption of &gt;14 units per week.&#xD;
  &#xD;
            -  Positive urine drugs of abuse test and/or alcohol breath test at screening or on&#xD;
               admission to the unit on Day -1 that cannot be accounted for by concomitant medication&#xD;
               in the opinion of the Investigator.&#xD;
  &#xD;
            -  Current or previous use of tobacco, nicotine products or e-cigarettes in the past 6&#xD;
               months.&#xD;
  &#xD;
            -  Smoking history of &gt; 5 pack years.&#xD;
  &#xD;
            -  Positive urine cotinine test at screening or Day -1.&#xD;
  &#xD;
            -  Receiving any of the prohibited concomitant medications as specified in Section&#xD;
               5.5.3.1.&#xD;
  &#xD;
            -  Known history of intolerance or hypersensitivity to AX-202 or to any other component&#xD;
               of the formulation.&#xD;
  &#xD;
            -  Known history of intolerance to placebo or excipients.&#xD;
  &#xD;
            -  Participation in another clinical study with an experimental drug within 3 months&#xD;
               (non-biologic), 6 months (biologic) or 5 half-lives, whichever is longer, before the&#xD;
               administration of IMP.&#xD;
  &#xD;
          Part B / Multiple ascending doses:&#xD;
  &#xD;
            -  History or presence of any clinically relevant acute or chronic medical or psychiatric&#xD;
               condition other than psoriasis that could interfere with the patient's safety during&#xD;
               the clinical study or expose the patient to undue risk as judged by the Investigator.&#xD;
  &#xD;
            -  A diagnosis of non-plaque psoriasis.&#xD;
  &#xD;
            -  Plaque psoriasis restricted to the scalp, palms, soles and face.&#xD;
  &#xD;
            -  Pustular, erythrodermic, inverse, and guttate psoriasis&#xD;
  &#xD;
            -  Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers,&#xD;
               calcium channel inhibitors or lithium)&#xD;
  &#xD;
            -  Diagnosis of psoriatic arthritis, uveitis, inflammatory bowel disease, or other&#xD;
               immune-mediated conditions that are commonly associated with psoriasis for which a&#xD;
               patient requires current systemic (oral, subcutaneous [SC], or IV) (including&#xD;
               corticosteroids, immunosuppressants, biologics) immunosuppressant medical treatment.&#xD;
  &#xD;
            -  Presence of other skin conditions that could interfere with psoriasis evaluation or&#xD;
               assessments as judged by the Investigator.&#xD;
  &#xD;
            -  After a minimum of 10 minutes supine rest at the time of screening or on Day -1:&#xD;
  &#xD;
                 -  Systolic blood pressure &lt;90 or &gt;140 mmHg, or&#xD;
  &#xD;
                 -  Diastolic blood pressure &lt;50 or &gt;90 mmHg, or&#xD;
  &#xD;
                 -  Pulse &lt;40 or &gt;90 bpm 9. Any clinically significant abnormalities in resting ECG&#xD;
                    at the time of screening or on Day -1 including prolonged QTcF (&gt;450 ms for&#xD;
                    males; &gt;470 ms for females using the mean of triplicate ECG's) and cardiac&#xD;
                    arrhythmias, as judged by the Investigator.&#xD;
  &#xD;
            -  Clinically significant abnormalities in renal function at screening.&#xD;
  &#xD;
            -  Clinically significant abnormalities in liver function at screening.&#xD;
  &#xD;
            -  Haemoglobin &lt;130 g/l for males or &lt;120 g/l for females at screening.&#xD;
  &#xD;
            -  Any clinically significant illness, medical/surgical procedure or trauma within 4&#xD;
               weeks of the first administration of IMP (Day 1).&#xD;
  &#xD;
            -  Malignancy within the past 5 years of screening with the exception of in-situ removal&#xD;
               of basal cell carcinoma or resected benign colonic polyps.&#xD;
  &#xD;
            -  Any planned major surgery within the duration of the study or in the 30 days following&#xD;
               study completion.&#xD;
  &#xD;
            -  History of latent or active tuberculosis, or a positive QuantiFERON® TB Gold result at&#xD;
               screening.&#xD;
  &#xD;
            -  Females who are pregnant, breast feeding, lactating or plan to be pregnant during the&#xD;
               study period or 120 days after.&#xD;
  &#xD;
            -  Female patients with a positive serum or urine pregnancy test (minimum sensitivity 25&#xD;
               IU/L or equivalent units of human chorionic gonadotropin [HCG]) at screening or on Day&#xD;
               -1.&#xD;
  &#xD;
            -  Positive serum hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies&#xD;
               (HCVAb) or human immunodeficiency virus (HIV) 1 and/or 2 antibodies at screening.&#xD;
  &#xD;
            -  A Positive test for active COVID -19 prior to dosing on Day 1.&#xD;
  &#xD;
            -  History of any drug and/or alcohol abuse in the past 2 years prior to screening.&#xD;
  &#xD;
            -  Regular alcohol consumption of &gt;14 units per week.&#xD;
  &#xD;
            -  Positive urine drugs of abuse test and/or alcohol breath test at screening or on&#xD;
               admission to the unit on Day -1 that cannot be accounted for by concomitant medication&#xD;
               in the opinion of the Investigator.&#xD;
  &#xD;
            -  Receiving any of the prohibited concomitant medications as specified in Section&#xD;
               5.5.3.2.&#xD;
  &#xD;
            -  Any clinically significant infection requiring antimicrobial treatment in the 2 weeks&#xD;
               prior to Day 1.&#xD;
  &#xD;
            -  Known history of intolerance or hypersensitivity to AX-202 or to any other component&#xD;
               of the formulation.&#xD;
  &#xD;
            -  Known history of intolerance to placebo or excipients.&#xD;
  &#xD;
            -  Participation in another clinical study with an experimental drug within 3 months&#xD;
               (non-biologic), 6 months (biologic) or 5 half-lives, whichever is longer, before the&#xD;
               administration of IMP.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Jonas Hallén, MD</last_name>
      <phone>+47 22 95 85 00</phone>
      <email>jonas.hallen@arxxtx.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sylvia Vetrhus, MScPharm</last_name>
      <phone>+47 22 95 85 00</phone>
      <email>sylvia.vetrhus@arxxtx.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Medicines Evaluation Unit</name>
        <address>
          <city>Manchester</city>
          <state>Wythenshawe</state>
          <zip>M23 9QZ</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Dave Singh</last_name>
        <phone>+44 (0)161 946 1450</phone>
        <email>enquiries@meu.org.uk</email>
      </contact>
      <investigator>
        <last_name>Dave Singh, Professor</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>June 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Single Ascending Doses</keyword>
    <keyword>Multiple Ascending Doses</keyword>
    <keyword>AX-202</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Psoriasis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The datasets generated and/or analysed during the current study will be available upon request from Arxx Therapeutics, contact details can be found at the following website: https://arxxtx.com/.&#xD;
  Deidentified individual participant data will be available after the study has been reported, approximately 12 months after the study's concluded. These data will be available for 36 months. These data will be shared with Investigators whose proposed use of the data has been approved by Arxx Therapeutics. Proposals may be submitted up to 36 months following reporting of the study.</ipd_description>
      <ipd_time_frame>Deidentified data will be available approximately 12 months after the study's concluded. These data will be available for 36 months. Proposals for use of data may be submitted up to 36 months following reporting of the study.</ipd_time_frame>
      <ipd_access_criteria>Data will be shared with Investigators whose proposed use of the data has been approved by Arxx Therapeutics.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05965089
  org study id: AX-202-01
  nct id: NCT05965089
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The first-in-human study will be performed in healthy volunteers and patients with a chronic
        inflammatory skin disease. The primary objective is to evaluate the safety, tolerability and
        pharmacokinetics of increasing doses of AX-202 infusion.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Single-ascending doses in healthy subjects and multiple ascending doses in patients with mild to moderate chronic plaque psoriasis
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  masking description: Double blind
  measure: To assess the safety and tolerability of a single ascending IV dose of AX-202 in healthy subjects and multiple ascending IV doses of AX-202 in patients with mild to moderate chronic plaque psoriasis by monitoring of adverse events.
  time frame: Until 100 days after last dose
  description: Number of patients with AE's
  measure: To assess the safety and tolerability of a single ascending IV dose of AX-202 in healthy subjects and multiple ascending IV doses of AX-202 in patients with mild to moderate chronic plaque psoriasis by physical examinations.
  time frame: Until 100 days after last dose
  description: Number of patients with clinically significant findings on physical examinations
  measure: To assess the safety and tolerability of a single ascending IV dose of AX-202 in healthy subjects and multiple ascending IV doses of AX-202 in patients with mild to moderate chronic plaque psoriasis by assessment of infusion related reactions
  time frame: Until 100 days after last dose
  description: Number of patients with infusion related reactions
  measure: To assess the safety and tolerability of a single ascending IV dose of AX-202 in healthy subjects and multiple ascending IV doses of AX-202 in patients with mild to moderate chronic plaque psoriasis by monitoring of vital signs
  time frame: Until 100 days after last dose
  description: Number of patients with clinically significant changes from baseline in vital signs
  measure: To assess the safety and tolerability of a single ascending IV dose of AX-202 in healthy subjects and multiple ascending IV doses of AX-202 in patients with mild to moderate chronic plaque psoriasis by monitoring of clinical laboratory parameters
  time frame: Until 100 days after last dose
  description: Number of patients with clinically significant change from baseline in clinical laboratory test results.
  measure: To assess the safety and tolerability of a single ascending IV dose of AX-202 in healthy subjects and multiple ascending IV doses of AX-202 in patients with mild to moderate chronic plaque psoriasis by ECG monitoring
  time frame: Until 100 days after last dose
  description: Number of patients with clinically significant change from baseline in ECG parameters
  measure: To characterise systemic PK of AX-202 after a single ascending IV dose in healthy subjects and after multiple ascending IV doses in patients with mild to moderate chronic plaque psoriasis.
  time frame: Until 100 days after last dose
  description: Calculation of maximum serum concentration (Cmax) of AX-202
  measure: To characterise systemic PK of AX-202 after a single ascending IV dose in healthy subjects and after multiple ascending IV doses in patients with mild to moderate chronic plaque psoriasis.
  time frame: Until 100 days after last dose
  description: Calculation of time to maximum concentration (tmax) of AX-202
  measure: To characterise systemic PK of AX-202 after a single ascending IV dose in healthy subjects and after multiple ascending IV doses in patients with mild to moderate chronic plaque psoriasis.
  time frame: Until 100 days after last dose
  description: Calculation of the area under the plasma concentration-time curve (AUC)
  measure: To characterise systemic PK of AX-202 after a single ascending IV dose in healthy subjects and after multiple ascending IV doses in patients with mild to moderate chronic plaque psoriasis.
  time frame: Until 100 days after last dose
  description: Calculation of the half-life of AX-202
  measure: To characterise systemic PK of AX-202 after a single ascending IV dose in healthy subjects and after multiple ascending IV doses in patients with mild to moderate chronic plaque psoriasis.
  time frame: Until 100 days after last dose
  description: Calculation of the clearance (CL) of AX-202
  measure: To characterise systemic PK of AX-202 after a single ascending IV dose in healthy subjects and after multiple ascending IV doses in patients with mild to moderate chronic plaque psoriasis.
  time frame: Until 100 days after last dose
  description: Calculation of volume of distribution at steady state (Vss)
  measure: To evaluate immunogenicity of AX-202 after a single ascending IV dose in healthy subjects and after multiple ascending IV doses in patients with mild to moderate chronic plaque psoriasis.
  time frame: Until 100 days after last dose
  description: Number of participants with anti-drug antibodies against AX-202
  arm group label: AX-202
  arm group type: Experimental
  description: Single and multiple ascending doses of AX-202
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Single and multiple doses of placebo
  intervention type: Biological
  intervention name: Placebo
  description: Placebo
  arm group label: Placebo
  intervention type: Biological
  intervention name: AX-202
  description: Humanized monoclonal antibody
  arm group label: AX-202
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jonas Hallén, MD
  phone: +47 22 95 85 00
  email: jonas.hallen@arxxtx.com
  last name: Sylvia Vetrhus, MScPharm
  phone: +47 22 95 85 00
  email: sylvia.vetrhus@arxxtx.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Psoriasis
  sharing ipd: Yes
  ipd description: The datasets generated and/or analysed during the current study will be available upon request from Arxx Therapeutics, contact details can be found at the following website: https://arxxtx.com/.
  Deidentified individual participant data will be available after the study has been reported, approximately 12 months after the study's concluded. These data will be available for 36 months. These data will be shared with Investigators whose proposed use of the data has been approved by Arxx Therapeutics. Proposals may be submitted up to 36 months following reporting of the study.
  ipd time frame: Deidentified data will be available approximately 12 months after the study's concluded. These data will be available for 36 months. Proposals for use of data may be submitted up to 36 months following reporting of the study.
  ipd access criteria: Data will be shared with Investigators whose proposed use of the data has been approved by Arxx Therapeutics.