<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/NCT04485663</url>
  </required_header>
  <id_info>
    <org_study_id>ALG-010133-101</org_study_id>
    <nct_id>NCT04485663</nct_id>
  </id_info>
  <brief_title>A Study of ALG-010133 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects</brief_title>
  <official_title>A Phase 1, Double-blind, Randomized, Placebo-controlled, First-in-human Study of Subcutaneously Administered ALG-010133 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single Ascending Doses (Part 1) and Multiple Ascending Doses in Healthy Volunteers (Part 2), and Multiple Doses in Subjects With Chronic Hepatitis B (Part 3)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aligos Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aligos Therapeutics</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Randomized Study of ALG-010133 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and&#xD;
      Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of antiviral activity at the projected efficacious dose.&#xD;
  </why_stopped>
  <start_date type="Actual">August 17, 2020</start_date>
  <completion_date type="Actual">March 8, 2022</completion_date>
  <primary_completion_date type="Actual">March 8, 2022</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]</measure>
    <time_frame>up to 15 days for Part 1</time_frame>
    <description>The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]</measure>
    <time_frame>up to 29 days for Part 2</time_frame>
    <description>The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]</measure>
    <time_frame>up to 162 days for Part 3</time_frame>
    <description>The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum Plasma Concentration [Cmax]</measure>
    <time_frame>Predose (0 hours) up to 162 Days (3864 hours)</time_frame>
    <description>Pharmacokinetic parameters of ALG-010133 in plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration time curve [AUC]</measure>
    <time_frame>Predose (0 hours) up to 162 Days (3864 hours)</time_frame>
    <description>Pharmacokinetic parameters of ALG-010133 in plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to maximum plasma concentration [Tmax]</measure>
    <time_frame>Predose (0 hours) up to 162 Days (3864 hours)</time_frame>
    <description>Pharmacokinetic parameters of ALG-010133 in plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Half-time [t1/2]</measure>
    <time_frame>Predose (0 hours) up to 162 Days (3864 hours)</time_frame>
    <description>Pharmacokinetic parameters of ALG-010133 in plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum Plasma Concentration [Cmin]</measure>
    <time_frame>Predose (0 hours) up to 162 Days (3864 hours)</time_frame>
    <description>Pharmacokinetic parameters of ALG-010133 in plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HBsAg (reduction) from baseline through Day 78 in Multiple Dose HBV Infected Patients</measure>
    <time_frame>Screening, Day -1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">103</enrollment>
  <condition>Chronic Hepatitis B</condition>
  <arm_group>
    <arm_group_label>ALG-010133</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subcutaneous injections of ALG-010133 in HV or CHB subjects up to every 7 days for up to 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subcutaneous injections of placebo in HV or CHB subjects up to every 7 days for up to 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ALG-010133</intervention_name>
    <description>Single or multiple doses of ALG-010133</description>
    <arm_group_label>ALG-010133</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Single or multiple doses of Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for Healthy Subjects:&#xD;
&#xD;
          1. Male and Female between 18 and 55 years old&#xD;
&#xD;
          2. Female subjects must have a negative serum pregnancy test at screening&#xD;
&#xD;
          3. Subjects must be nonsmokers for at least 3 months prior to randomization&#xD;
&#xD;
          4. BMI 18.0 to 32.0 kg/m^2&#xD;
&#xD;
          5. Subjects must have a 12-lead ECG that meets protocol criteria&#xD;
&#xD;
        Inclusion Criteria for CHB Subjects:&#xD;
&#xD;
          1. Male and Female between 18 and 70 years old&#xD;
&#xD;
          2. Female subjects must have a negative serum pregnancy test at screening&#xD;
&#xD;
          3. BMI 18.0 to 35.0 kg/m^2&#xD;
&#xD;
          4. HBeAg-negative chronic hepatitis B or HBeAg-positive chronic hepatitis B and are&#xD;
             currently receiving HBV NA treatment for ≥6 months prior to screening&#xD;
&#xD;
          5. Subjects must have a 12-lead ECG that meets protocol criteria&#xD;
&#xD;
        Exclusion Criteria for Healthy Subjects:&#xD;
&#xD;
          1. Subjects with any current or previous illness that, in the opinion of the&#xD;
             Investigator, might confound the results of the study or pose an additional risk in&#xD;
             administering study drug to the subject or that could prevent, limit, or confound the&#xD;
             protocol specified assessments or study results' interpretation&#xD;
&#xD;
          2. Subjects with a past history of cardiac arrhythmias, risk factors for Torsade de&#xD;
             Pointes syndrome (e.g., hypokalemia, family history of long QT Syndrome) or history or&#xD;
             clinical evidence at screening of significant or unstable cardiac disease etc.&#xD;
&#xD;
          3. Subjects with a history of clinically significant drug allergy&#xD;
&#xD;
          4. Subject with current or history of clinically significant (as determined by the&#xD;
             Investigator) skin disease requiring intermittent or chronic treatment&#xD;
&#xD;
          5. Excessive use of alcohol defined as regular consumption of ≥14 units/week for women&#xD;
             and ≥21 units/week for men&#xD;
&#xD;
          6. Unwilling to abstain from alcohol use for 48 hours prior to start of dosing through&#xD;
             end of study follow up&#xD;
&#xD;
          7. Subjects with Hepatitis A, B, C, D, E or HIV-1/HIV-2 infection or acute infections&#xD;
             such as SARS- CoV-2 infection&#xD;
&#xD;
          8. Subjects with renal dysfunction (e.g., estimated creatinine clearance &lt;90 mL/min/1.73&#xD;
             m^2 at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration&#xD;
             [CKD-EPI] formula)&#xD;
&#xD;
        Exclusion Criteria for CHB Subjects:&#xD;
&#xD;
          1. Subjects with any current or previous illness that, in the opinion of the&#xD;
             Investigator, might confound the results of the study or pose an additional risk in&#xD;
             administering study drug to the subject or that could prevent, limit, or confound the&#xD;
             protocol specified assessments or study results' interpretation&#xD;
&#xD;
          2. Subjects with a past history of cardiac arrhythmias, risk factors for Torsade de&#xD;
             Pointes syndrome (e.g., hypokalemia, family history of long QT Syndrome) or history or&#xD;
             clinical evidence at screening of significant or unstable cardiac disease etc.&#xD;
&#xD;
          3. Subjects with a history of clinically significant drug allergy&#xD;
&#xD;
          4. Subject with current or history of clinically significant (as determined by the&#xD;
             Investigator) skin disease requiring intermittent or chronic treatment&#xD;
&#xD;
          5. Excessive use of alcohol defined as regular consumption of ≥14 units/week for women&#xD;
             and ≥21 units/week for men&#xD;
&#xD;
          6. Subjects with Hepatitis A, C, D, E or HIV-1/HIV-2 infection or acute infections such&#xD;
             as SARS- CoV-2 infection&#xD;
&#xD;
          7. Subjects with renal dysfunction (e.g., estimated creatinine clearance &lt;90 mL/min/1.73&#xD;
             m^2 at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration&#xD;
             [CKD-EPI] formula)&#xD;
&#xD;
          8. Subject with any history or current evidence of hepatic decompensation such as:&#xD;
             variceal bleeding, spontaneous bacterial peritonitis, ascites, hepatic encephalopathy,&#xD;
             or active jaundice (within the last year)&#xD;
&#xD;
          9. Subjects must have absence of signs of hepatocellular carcinoma&#xD;
&#xD;
         10. Subjects with history or current liver cirrhosis&#xD;
&#xD;
         11. Subjects positive for anti-HBs anitbodies&#xD;
&#xD;
         12. Subjects with liver fibrosis that is classified as Metavir Score ≥F3&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Nanfang Hospital of Southern Medical University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Jilin University</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Mary Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pusan National University Hospital</name>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital, Yonsei University Health System</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMSI Republican Clinical Hospital &quot;T. Mosneaga&quot;, ARENSIA Exploratory Medicine Phase I Unit</name>
      <address>
        <city>Chisinau</city>
        <country>Moldova, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ACS</name>
      <address>
        <city>Auckland</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King's College Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
    <country>Hong Kong</country>
    <country>Korea, Republic of</country>
    <country>Moldova, Republic of</country>
    <country>New Zealand</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>March 14, 2022</last_update_submitted>
  <last_update_submitted_qc>March 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis B</mesh_term>
    <mesh_term>Hepatitis B, Chronic</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Hepatitis, Chronic</mesh_term>
  </condition_browse>
  <!-- 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/NCT04485663
org study id: ALG-010133-101
nct id: NCT04485663
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A Randomized Study of ALG-010133 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and
      Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
time frame: up to 15 days for Part 1
description: The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
time frame: up to 29 days for Part 2
description: The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
time frame: up to 162 days for Part 3
description: The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
measure: Maximum Plasma Concentration [Cmax]
time frame: Predose (0 hours) up to 162 Days (3864 hours)
description: Pharmacokinetic parameters of ALG-010133 in plasma
measure: Area under the concentration time curve [AUC]
time frame: Predose (0 hours) up to 162 Days (3864 hours)
description: Pharmacokinetic parameters of ALG-010133 in plasma
measure: Time to maximum plasma concentration [Tmax]
time frame: Predose (0 hours) up to 162 Days (3864 hours)
description: Pharmacokinetic parameters of ALG-010133 in plasma
measure: Half-time [t1/2]
time frame: Predose (0 hours) up to 162 Days (3864 hours)
description: Pharmacokinetic parameters of ALG-010133 in plasma
measure: Minimum Plasma Concentration [Cmin]
time frame: Predose (0 hours) up to 162 Days (3864 hours)
description: Pharmacokinetic parameters of ALG-010133 in plasma
measure: Change in HBsAg (reduction) from baseline through Day 78 in Multiple Dose HBV Infected Patients
time frame: Screening, Day -1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78
arm group label: ALG-010133
arm group type: Experimental
description: Subcutaneous injections of ALG-010133 in HV or CHB subjects up to every 7 days for up to 12 weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: Subcutaneous injections of placebo in HV or CHB subjects up to every 7 days for up to 12 weeks
intervention type: Drug
intervention name: ALG-010133
description: Single or multiple doses of ALG-010133
arm group label: ALG-010133
intervention type: Drug
intervention name: Placebo
description: Single or multiple doses of Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
country: Hong Kong
country: Korea, Republic of
country: Moldova, Republic of
country: New Zealand
country: United Kingdom
responsible party type: Sponsor
mesh term: Hepatitis B
mesh term: Hepatitis B, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic