Actively Recruiting
A Phase I, Open-label, Single Dose Escalation Study to Evaluate Pharmacokinetics, Safety and Tolerability of Long-acting Cabotegravir with Recombinant Human Hyaluronidase PH20 in Healthy Adults
Led by ViiV Healthcare · Updated on 2025-12-18
214
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
V
ViiV Healthcare
Lead Sponsor
G
GlaxoSmithKline
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and how the body processes single doses of long-acting Cabotegravir (CAB) combined with Recombinant Human Hyaluronidase PH20 (rHuPH20) and other formulations in healthy adult volunteers. This open-label, dose-escalation study includes several parts focusing on different dose levels and formulations, including single and repeat doses administered subcutaneously or intramuscularly. Part A has closed enrollment based on preliminary results, and Part D will not be conducted due to study design changes. Participants receive various doses and formulations of CAB, including 200 mg/mL with rHuPH20, doses greater than or equal to 400 mg/mL by injection, and specific formulations I and J by intramuscular injection. Rilpivirine (RPV) is also administered in some parts of the study intramuscularly. The study involves monitoring different dosing cohorts over set periods, with Part A and other parts having specific timelines for dosing and evaluation. During the study, participants undergo regular blood tests to measure drug levels and various health markers, including hematology and clinical chemistry parameters. Researchers track drug concentrations at multiple weeks up to 78 weeks depending on the cohort, monitor adverse events, and assess pharmacokinetic parameters such as maximum plasma concentration and half-life. Safety and tolerability are assessed throughout, with detailed laboratory and cardiac monitoring. The total study duration and follow-up periods vary by cohort and study part.
CONDITIONS
Brief Title
A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 55 years at time of consent
- Overtly healthy based on medical history, physical exam, lab tests, and cardiac monitoring
- Body weight at least 40 kg and BMI between 18 and 32 kg/m²
- Negative COVID-19 test on day of admission
- Use of contraception consistent with local regulations for both men and women
- Able to give written informed consent
You will not qualify if you...
- History or current presence of cardiovascular, respiratory, liver, kidney, gastrointestinal, endocrine, blood, or neurological disorders
- Liver disease or known hepatic or biliary abnormalities
- Seizure disorder or treatment for seizures within past 2 years
- Positive COVID-19 test or symptoms or exposure within 14 days before admission
- Positive HIV-1 or HIV-2 antibody/antigen test
- High-risk behaviors increasing HIV infection risk
- Presence of hepatitis B surface antigen or positive hepatitis C antibody within 3 months prior to dosing
- Abnormal blood pressure or previous heart attack
- Heart conduction abnormalities or significant arrhythmias
- Abnormal electrocardiogram results
- Elevated liver enzymes or bilirubin above specified limits
- Reduced kidney function (eGFR <60 mL/min)
- Low hemoglobin below specified levels for men and women
- Positive drug or alcohol screen before study
- Use of tobacco or nicotine products within 3 months or alcohol above set limits
- Use of drugs of abuse
- Participation in another clinical trial or investigational product within required washout periods
- Blood loss exceeding 500 mL within 56 days
- Exposure to more than four new chemical entities within 12 months before dosing
- Allergic reactions or hypersensitivity to study drugs or components including hyaluronidases
- Need for chronic anti-coagulation therapy
- Hereditary coagulation or platelet disorders
- Tattoos or skin conditions at injection sites
- Other medical, behavioral, or treatment factors making participation unsuitable
- Significant risk of suicidality based on investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 78 weeks depending on cohort assignment
Participants receive a single dose of one of several formulations of Cabotegravir with or without recombinant human hyaluronidase PH20 or RPV via injection to evaluate pharmacokinetics, safety and tolerability.
Multiple visits for pharmacokinetic sampling and safety assessments up to Week 78
Trial Site Locations
Total: 3 locations
1
GSK Investigational Site
Orlando, Florida, United States, 32806
Completed
2
GSK Investigational Site
Las Vegas, Nevada, United States, 89113
Actively Recruiting
3
GSK Investigational Site
Austin, Texas, United States, 78744
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
E
EU GSK Clinical Trials Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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