A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Suspension Injection of Investigational Capsid Inhibitors Compared to Placebo in Healthy Adults
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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Contact
Study Contact
- Name: US GSK Clinical Trials Call Center
- Phone Number: 877-379-3718
- Email: GSKClinicalSupportHD@gsk.com
Study Contact Backup
- Name: EU GSK Clinical Trials Call Center
- Phone Number: +44 (0) 20 89904466
- Email: GSKClinicalSupportHD@gsk.com
Study Locations
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-
Nevada
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Las Vegas, Nevada, United States, 89113
- GSK Investigational Site
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Texas
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Austin, Texas, United States, 78744
- GSK Investigational Site
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants who are overtly healthy.
- Participants who are negative on a single test for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (approved molecular polymerase chain reaction (PCR), point of care test), performed on the day of admission (Day -1). A negative result is required prior to the administration of study intervention on Day 1.
- Male or female participants of non-childbearing potential.
- Capable of giving signed informed consent.
Exclusion Criteria:
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neurological or psychiatric disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
- Abnormal blood pressure.
- Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- Breast cancer within the past 10 years.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities.
- History of sensitivity to any of the study interventions, a history of drug allergy or other allergy that contraindicates their participation.
- The participant has an underlying skin disease or disorder that would interfere with assessment of injection sites.
- Participants considered to have insufficient musculature to allow safe capsid inhibitor intramuscular (gluteus medius) administration.
- History of or on-going high-risk behaviours that may put the participant at increased risk for HIV.
- Past or intended use of over-the-counter or prescription medication including herbal medications.
- Current enrollment or recent past participation in another investigational study.
- Exposure to more than 4 investigational products within 12 months prior to dosing.
- Alanine transaminase (ALT) ≥1.5x upper limit of normal (ULN), Total bilirubin ≥1.5x ULN (isolated total bilirubin >1.5xULN), and/or estimated creatinine clearance (eGFR) of <60 millilitre per minute (mL/min)/1.73 square meter (m^2).
- History of or current infection with hepatitis B or hepatitis C.
- Positive SARS-CoV-2 polymerase chain reaction test, having signs and symptoms, or having contact with known coronavirus disease 2019 (COVID-19) positive person/s in the 14 days prior to inpatient admission.
- Use of tobacco or nicotine-containing products, regular alcohol consumption and/or regular use of known drugs of abuse.
- Positive HIV antibody/antigen test.
- Abnormal electrocardiogram (ECG) parameters.
- Evidence of previous myocardial infarction, any conduction abnormality, any significant arrhythmia, non-sustained or sustained ventricular tachycardia, and/or sinus pauses (>3 seconds).
- The participant has a tattoo or other dermatological condition overlying the location of injection or a prior history of silicone implants or fillers (gluteal) which may interfere with interpretation of injection site reactions or administration of study product.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Part 1 Single Ascending Dose (SAD): Participants Receiving VH4004280
VH4004280 injections are administered subcutaneously (SC), SC+ rHuPH20, or intramuscularly (IM).
|
VH4004280 will be administered.
|
|
Placebo Comparator: Part 1: Participants Receiving Placebo
Placebo injection is administered.
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Placebo will be administered.
|
|
Experimental: Part 2 SAD: Participants Receiving VH4011499
VH4011499 injections are administered SC, SC+ rHuPH20, or IM.
|
VH4011499 will be administered.
|
|
Experimental: Part 2 Multiple Ascending Dose (MAD): Participants Receiving VH4011499
VH4011499 injections are administered IM.
|
VH4011499 will be administered.
|
|
Placebo Comparator: Part 2: Participants Receiving Placebo
Placebo injection is administered.
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Placebo will be administered.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Area Under the Plasma-concentration Time curve from Time Zero to Infinity (AUC0-inf) of VH4004280
Time Frame: Up to Week 52
|
Up to Week 52
|
|
|
Maximum Observed Plasma Concentration (Cmax) of VH4004280
Time Frame: Up to Week 52
|
Up to Week 52
|
|
|
Time of Maximum Observed Plasma Concentration (tmax) of VH4004280
Time Frame: Up to Week 52
|
Up to Week 52
|
|
|
Apparent Terminal Half-life (t1/2) of VH4004280
Time Frame: Up to Week 52
|
Up to Week 52
|
|
|
SAD: Number of Participants with Adverse Events (AEs) as per Severity
Time Frame: Up to Week 52
|
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.
|
Up to Week 52
|
|
MAD: Number of Participants with Adverse Events (AEs) as per Severity
Time Frame: Up to Week 56
|
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.
|
Up to Week 56
|
|
SAD: Absolute Values of Liver Chemistry Parameters: Total Bilirubin and Direct Bilirubin (micromoles per liter [umol/L])
Time Frame: Up to Week 52
|
Up to Week 52
|
|
|
MAD: Absolute Values of Liver Chemistry Parameters: Total Bilirubin and Direct Bilirubin (micromoles per liter [umol/L])
Time Frame: Up to Week 56
|
Up to Week 56
|
|
|
SAD: 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
|
Baseline (Prior to Day 1) and up to Week 52
|
|
|
MAD: 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 56
|
Baseline (Prior to Day 1) and up to Week 56
|
|
|
SAD: 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
|
Up to Week 52
|
|
|
MAD: 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 56
|
Up to Week 56
|
|
|
SAD: 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
|
Up to Week 52
|
|
|
MAD: Absolute Values of Liver Chemistry Parameters: Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) (International Units per liter)
Time Frame: Up to Week 56
|
Up to Week 56
|
|
|
SAD: 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
|
Baseline (Prior to Day 1) and up to Week 52
|
|
|
MAD: 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 56
|
Baseline (Prior to Day 1) and up to Week 56
|
|
|
SAD: Number of Participants with Injection Site Reactions (ISR) AE by Grade Using the DAIDS Grading Scale
Time Frame: Up to Week 52
|
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.
|
Up to Week 52
|
|
MAD: Number of Participants with Injection Site Reactions (ISR) AE by Grade Using the DAIDS Grading Scale
Time Frame: Up to Week 56
|
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.
|
Up to Week 56
|
|
SAD: Duration of ISR (Days) AE
Time Frame: Up to Week 52
|
Duration of ISR will be assessed as the time up to which a reaction related to injection site event is persistent.
|
Up to Week 52
|
|
MAD: Duration of ISR (Days) AE
Time Frame: Up to Week 56
|
Duration of ISR will be assessed as the time up to which a reaction related to injection site event is persistent.
|
Up to Week 56
|
|
Area Under the Plasma-concentration Time curve from Time Zero to Infinity (AUC0-inf) of VH4011499
Time Frame: Up to Week 56
|
Up to Week 56
|
|
|
Maximum Observed Plasma Concentration (Cmax) of VH4011499
Time Frame: Up to Week 56
|
Up to Week 56
|
|
|
Time of Maximum Observed Plasma Concentration (tmax) of VH4011499
Time Frame: Up to Week 56
|
Up to Week 56
|
|
|
Apparent Terminal Half-life (t1/2) of VH4011499
Time Frame: Up to Week 56
|
Up to Week 56
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Estimated)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Blood-Borne Infections
- Urogenital Diseases
- Genital Diseases
- Immune System Diseases
- Infections
- RNA Virus Infections
- Virus Diseases
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Substandard Drugs
- Pharmaceutical Preparations
- Counterfeit Drugs
Other Study ID Numbers
Other Study ID Numbers
- 218306
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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