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Completed

NCT Number: NCT06012136

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Suspension Injection of Investigational Capsid Inhibitors Compared to Placebo in Healthy Adults

The primary purpose of the study is to investigate safety and tolerability following single and multiple ascending subcutaneous (SC) and intramuscular (IM) doses of capsid inhibitors in healthy participants. The study will also describe the pharmacokinetics following single and multiple ascending SC and IM doses of capsid inhibitors in healthy participants.

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Key information

Conditions

HIV Infections Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site, Las Vegas, Nevada, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VH4004280

Drug

VH4004280 will be administered.

Placebo

Drug

Placebo will be administered.

VH4011499

Drug

VH4011499 will be administered.

Primary outcomes

  1. 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.

  2. 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.

  3. SAD: Absolute Values of Liver Chemistry Parameters: Total Bilirubin and Direct Bilirubin (micromoles per liter [umol/L])

    Time frame: Up to Week 52

  4. MAD: Absolute Values of Liver Chemistry Parameters: Total Bilirubin and Direct Bilirubin (micromoles per liter [umol/L])

    Time frame: Up to Week 56

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. Area Under the Plasma-concentration Time curve from Time Zero to Infinity (AUC0-inf) of VH4004280

    Time frame: Up to Week 52

  18. Area Under the Plasma-concentration Time curve from Time Zero to Infinity (AUC0-inf) of VH4011499

    Time frame: Up to Week 56

  19. Maximum Observed Plasma Concentration (Cmax) of VH4004280

    Time frame: Up to Week 52

  20. Maximum Observed Plasma Concentration (Cmax) of VH4011499

    Time frame: Up to Week 56

  21. Time of Maximum Observed Plasma Concentration (tmax) of VH4004280

    Time frame: Up to Week 52

  22. Time of Maximum Observed Plasma Concentration (tmax) of VH4011499

    Time frame: Up to Week 56

  23. Apparent Terminal Half-life (t1/2) of VH4004280

    Time frame: Up to Week 52

  24. Apparent Terminal Half-life (t1/2) of VH4011499

    Time frame: Up to Week 56

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 25, 2023
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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