Sign in

NCT06012136CompletedPhase 1

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

Source: ClinicalTrials.gov · Last updated 5 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
85 (actual)
First submitted
21 Aug 2023
Start date
24 Aug 2023
Primary completion date
9 Jun 2026
Lead sponsor
ViiV Healthcare
Diseases
HIV
NCT number
NCT06012136

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 85
  • From 24 Aug 2023 to the primary completion date, 9 Jun 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants considered to have insufficient musculature to allow safe capsid inhibitor intramuscular (gluteus medius) administration.
  • Past or intended use of over-the-counter or prescription medication including herbal medications.
  • Exposure to more than 4 investigational products within 12 months prior to dosing.
  • 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.
  • 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.

Other illness

  • 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.
  • 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.
  • History of or on-going high-risk behaviours that may put the participant at increased risk for HIV.
  • History of or current infection with hepatitis B or hepatitis C.
  • Positive HIV antibody/antigen test.

Lab values

  • 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).

Other

  • Abnormal blood pressure.
  • Current enrollment or recent past participation in another investigational study.
  • Abnormal electrocardiogram (ECG) parameters.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
GSK Investigational Site
Coordinator of this site? Confirm its status
AustinUnited StatesUnknown status
GSK Investigational Site
Coordinator of this site? Confirm its status
Las VegasUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.