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/NCT06012136</url>
    </required_header>
    <id_info>
      <org_study_id>218306</org_study_id>
      <nct_id>NCT06012136</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Suspension Injection of Investigational Capsid Inhibitors Compared to Placebo in Healthy Adults</brief_title>
    <official_title>A Phase 1 Double-Blind (Sponsor-unblinded), Placebo-Controlled, Randomized, Single Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Parenterally Administered Suspension of Investigational Capsid Inhibitors in Healthy Adults</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>ViiV Healthcare</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>ViiV Healthcare</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The primary purpose of the study is to investigate safety and tolerability following single&#xD;
        ascending subcutaneous (SC) and intramuscular (IM) doses of capsid inhibitor in healthy&#xD;
        participants. The study will also describe the pharmacokinetics following single ascending SC&#xD;
        and IM doses of capsid inhibitor in healthy participants.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 22, 2023</start_date>
    <completion_date type="Anticipated">May 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">May 1, 2026</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>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of Participants with Adverse Events (AEs) as per Severity</measure>
      <time_frame>Up to Week 52</time_frame>
      <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Severity of Adverse Event will be assessed using Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS). DAIDS grading scale is used to grade the toxicity associated with injection site reactions (ISR) including injection site pain (or tenderness), erythema (or redness), induration (or swelling), and pruritis. The toxicity level is graded from grade 1(lowest toxicity) to 4 (highest toxicity). Higher grade indicates higher toxicity.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Absolute Values of Liver Chemistry Parameters: Total Bilirubin and Direct Bilirubin (micromoles per liter [umol/L])</measure>
      <time_frame>Up to Week 52</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from Baseline in Liver Chemistry Parameters: Total Bilirubin and Direct Bilirubin (umol/L)</measure>
      <time_frame>Baseline (Prior to Day 1) and up to Week 52</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants with Maximum Toxicity Grade Change from Baseline in Liver Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT)</measure>
      <time_frame>Up to Week 52</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Absolute Values of Liver Chemistry Parameters: Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) (International Units per liter)</measure>
      <time_frame>Up to Week 52</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from Baseline in Liver Chemistry Parameters: Alkaline Phosphatase, AST, and ALT (International Units per liter)</measure>
      <time_frame>Baseline (Prior to Day 1) and up to Week 52</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants with Injection Site Reactions (ISR) AE by Grade Using the DAIDS Grading Scale</measure>
      <time_frame>Up to Week 52</time_frame>
      <description>DAIDS grading scale is used to grade the toxicity associated with injection site reactions (ISR) including injection site pain (or tenderness), erythema (or redness), induration (or swelling), and pruritis. The toxicity level is graded from grade 1(lowest toxicity) to 4 (highest toxicity). Higher grade indicates higher toxicity.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Duration of ISR (Days) AE</measure>
      <time_frame>Up to Week 52</time_frame>
      <description>Duration of ISR will be assessed as the time up to which a reaction related to injection site event is persistent.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Area Under the Plasma-concentration Time curve from Time Zero to Infinity (AUC0-inf)</measure>
      <time_frame>Up to Week 52</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Maximum Observed Plasma Concentration (Cmax)</measure>
      <time_frame>Up to Week 52</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Time of Maximum Observed Plasma Concentration (tmax)</measure>
      <time_frame>Up to Week 52</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Apparent Terminal Half-life (t1/2)</measure>
      <time_frame>Up to Week 52</time_frame>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">160</enrollment>
    <condition>HIV Infections</condition>
    <arm_group>
      <arm_group_label>Participants Receiving VH4004280</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Participants Receiving Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>VH4004280</intervention_name>
      <description>VH4004280 will be administered.</description>
      <arm_group_label>Participants Receiving VH4004280</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo will be administered.</description>
      <arm_group_label>Participants Receiving Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants who are overtly healthy.&#xD;
  &#xD;
            -  Participants who are negative on a single test for Severe Acute Respiratory Syndrome&#xD;
               Coronavirus 2 (SARS-CoV-2) (approved molecular polymerase chain reaction (PCR), point&#xD;
               of care test), performed on the day of admission (Day -1). A negative result is&#xD;
               required prior to the administration of study intervention on Day 1.&#xD;
  &#xD;
            -  Male or female participants of non-childbearing potential.&#xD;
  &#xD;
            -  Capable of giving signed informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal,&#xD;
               endocrine, hematological, neurological or psychiatric disorders capable of&#xD;
               significantly altering the absorption, metabolism, or elimination of drugs;&#xD;
               constituting a risk when taking the study intervention or interfering with the&#xD;
               interpretation of data.&#xD;
  &#xD;
            -  Abnormal blood pressure.&#xD;
  &#xD;
            -  Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or&#xD;
               squamous epithelial carcinomas of the skin that have been resected with no evidence of&#xD;
               metastatic disease for 3 years.&#xD;
  &#xD;
            -  Breast cancer within the past 10 years.&#xD;
  &#xD;
            -  Current or chronic history of liver disease or known hepatic or biliary abnormalities.&#xD;
  &#xD;
            -  History of sensitivity to any of the study interventions, a history of drug allergy or&#xD;
               other allergy that contraindicates their participation.&#xD;
  &#xD;
            -  The participant has an underlying skin disease or disorder that would interfere with&#xD;
               assessment of injection sites.&#xD;
  &#xD;
            -  Participants considered to have insufficient musculature to allow safe capsid&#xD;
               inhibitor intramuscular (gluteus medius) administration.&#xD;
  &#xD;
            -  History of or on-going high-risk behaviours that may put the participant at increased&#xD;
               risk for HIV.&#xD;
  &#xD;
            -  Past or intended use of over-the-counter or prescription medication including herbal&#xD;
               medications.&#xD;
  &#xD;
            -  Current enrollment or recent past participation in another investigational study.&#xD;
  &#xD;
            -  Exposure to more than 4 investigational products within 12 months prior to dosing.&#xD;
  &#xD;
            -  Alanine transaminase (ALT) ≥1.5x upper limit of normal (ULN), Total bilirubin ≥1.5x&#xD;
               ULN (isolated total bilirubin &gt;1.5xULN), and/or estimated creatinine clearance (eGFR)&#xD;
               of &lt;60 millilitre per minute (mL/min)/1.73 square meter (m^2).&#xD;
  &#xD;
            -  History of or current infection with hepatitis B or hepatitis C.&#xD;
  &#xD;
            -  Positive SARS-CoV-2 polymerase chain reaction test, having signs and symptoms, or&#xD;
               having contact with known coronavirus disease 2019 (COVID-19) positive person/s in the&#xD;
               14 days prior to inpatient admission.&#xD;
  &#xD;
            -  Use of tobacco or nicotine-containing products, regular alcohol consumption and/or&#xD;
               regular use of known drugs of abuse.&#xD;
  &#xD;
            -  Positive HIV antibody/antigen test.&#xD;
  &#xD;
            -  Abnormal electrocardiogram (ECG) parameters.&#xD;
  &#xD;
            -  Evidence of previous myocardial infarction, any conduction abnormality, any&#xD;
               significant arrhythmia, non-sustained or sustained ventricular tachycardia, and/or&#xD;
               sinus pauses (&gt;3 seconds).&#xD;
  &#xD;
            -  The participant has a tattoo or other dermatological condition overlying the location&#xD;
               of injection or a prior history of silicone implants or fillers (gluteal) which may&#xD;
               interfere with interpretation of injection site reactions or administration of study&#xD;
               product.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>EU GSK Clinical Trials Call Center</last_name>
      <phone>+44 (0) 20 89904466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Las Vegas</city>
          <state>Nevada</state>
          <zip>89113</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Austin</city>
          <state>Texas</state>
          <zip>78744</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Healthy participants</keyword>
    <keyword>Human Immunodeficiency Virus (HIV-1)</keyword>
    <keyword>VH4004280</keyword>
    <keyword>Long-Acting Injection</keyword>
    <keyword>Single ascending dose</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>HIV Infections</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.</ipd_time_frame>
      <ipd_access_criteria>Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.</ipd_access_criteria>
      <ipd_url>https://www.gsk.com/en-gb/innovation/trials/data-transparency/</ipd_url>
    </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/NCT06012136
  org study id: 218306
  nct id: NCT06012136
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  The primary purpose of the study is to investigate safety and tolerability following single
        ascending subcutaneous (SC) and intramuscular (IM) doses of capsid inhibitor in healthy
        participants. The study will also describe the pharmacokinetics following single ascending SC
        and IM doses of capsid inhibitor in healthy participants.
  allocation: Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Number of Participants with Adverse Events (AEs) as per Severity
  time frame: Up to Week 52
  description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Severity of Adverse Event will be assessed using Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS). DAIDS grading scale is used to grade the toxicity associated with injection site reactions (ISR) including injection site pain (or tenderness), erythema (or redness), induration (or swelling), and pruritis. The toxicity level is graded from grade 1(lowest toxicity) to 4 (highest toxicity). Higher grade indicates higher toxicity.
  measure: Absolute Values of Liver Chemistry Parameters: Total Bilirubin and Direct Bilirubin (micromoles per liter [umol/L])
  time frame: Up to Week 52
  measure: Change from Baseline in Liver Chemistry Parameters: Total Bilirubin and Direct Bilirubin (umol/L)
  time frame: Baseline (Prior to Day 1) and up to Week 52
  measure: Number of Participants with Maximum Toxicity Grade Change from Baseline in Liver Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT)
  time frame: Up to Week 52
  measure: Absolute Values of Liver Chemistry Parameters: Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) (International Units per liter)
  time frame: Up to Week 52
  measure: Change from Baseline in Liver Chemistry Parameters: Alkaline Phosphatase, AST, and ALT (International Units per liter)
  time frame: Baseline (Prior to Day 1) and up to Week 52
  measure: Number of Participants with Injection Site Reactions (ISR) AE by Grade Using the DAIDS Grading Scale
  time frame: Up to Week 52
  description: DAIDS grading scale is used to grade the toxicity associated with injection site reactions (ISR) including injection site pain (or tenderness), erythema (or redness), induration (or swelling), and pruritis. The toxicity level is graded from grade 1(lowest toxicity) to 4 (highest toxicity). Higher grade indicates higher toxicity.
  measure: Duration of ISR (Days) AE
  time frame: Up to Week 52
  description: Duration of ISR will be assessed as the time up to which a reaction related to injection site event is persistent.
  measure: Area Under the Plasma-concentration Time curve from Time Zero to Infinity (AUC0-inf)
  time frame: Up to Week 52
  measure: Maximum Observed Plasma Concentration (Cmax)
  time frame: Up to Week 52
  measure: Time of Maximum Observed Plasma Concentration (tmax)
  time frame: Up to Week 52
  measure: Apparent Terminal Half-life (t1/2)
  time frame: Up to Week 52
  arm group label: Participants Receiving VH4004280
  arm group type: Experimental
  arm group label: Participants Receiving Placebo
  arm group type: Placebo Comparator
  intervention type: Drug
  intervention name: VH4004280
  description: VH4004280 will be administered.
  arm group label: Participants Receiving VH4004280
  intervention type: Drug
  intervention name: Placebo
  description: Placebo will be administered.
  arm group label: Participants Receiving Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: US GSK Clinical Trials Call Center
  phone: 877-379-3718
  email: GSKClinicalSupportHD@gsk.com
  last name: EU GSK Clinical Trials Call Center
  phone: +44 (0) 20 89904466
  email: GSKClinicalSupportHD@gsk.com
  facility: 
  contact: 
  contact backup: 
  facility: 
  contact: 
  contact backup: 
  country: United States
  responsible party type: Sponsor
  mesh term: HIV Infections
  sharing ipd: Yes
  ipd description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
  ipd access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
  ipd url: https://www.gsk.com/en-gb/innovation/trials/data-transparency/