CompletedPhase 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

United States85 participantsStarted 2023-08-24

Plain-language summary

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.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 con…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This was a Phase 1 trial that only enrolled healthy adults without HIV — since I actually have HIV, what does that mean for how relevant these early safety findings are to someone like me, and would there be a later-phase trial I might be a better fit for?
2The trial closely monitored liver enzymes like ALT, AST, and bilirubin as key safety signals — do I have any existing liver conditions or current medication that would make those kinds of liver effects especially risky for me?
3The drugs were given as injection suspensions, and the study specifically tracked injection site reactions — how would that delivery method compare to the oral HIV medications I might already be taking or considering, and is that something worth factoring into my decision?
4Since this trial is already completed, would you be able to help me find out what the safety and pharmacokinetics results actually showed, and whether those results are leading to further studies I might be eligible for?
5These capsid inhibitors appear to be a new class of HIV treatment — compared to standard antiretroviral therapies that are already approved, what would be the reasoning for me to consider an experimental drug that's still in early-stage testing?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

SAD: Number of Participants with Adverse Events (AEs) as per Severity

Timeframe: Up to Week 52

MAD: Number of Participants with Adverse Events (AEs) as per Severity

Timeframe: Up to Week 56

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

Timeframe: Up to Week 52

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

Timeframe: Up to Week 56

SAD: Change from Baseline in Liver Chemistry Parameters: Total Bilirubin and Direct Bilirubin (umol/L)

Timeframe: 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)

Timeframe: 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)

Trial details

NCT IDNCT06012136

SponsorViiV Healthcare

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-09

View on ClinicalTrials.gov More HIV Infections trials

Plain-language summary

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

SAD: Number of Participants with Adverse Events (AEs) as per Severity

Timeframe: Up to Week 52

MAD: Number of Participants with Adverse Events (AEs) as per Severity

Timeframe: Up to Week 56

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

Timeframe: Up to Week 52

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

Timeframe: Up to Week 56

SAD: Change from Baseline in Liver Chemistry Parameters: Total Bilirubin and Direct Bilirubin (umol/L)

Timeframe: 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)

Timeframe: Baseline (Prior to Day 1) and up to Week 56