Actively Recruiting
A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants
Led by ViiV Healthcare · Updated on 2025-12-18
214
Participants Needed
3
Research Sites
260 weeks
Total Duration
On this page
Sponsors
V
ViiV Healthcare
Lead Sponsor
G
GlaxoSmithKline
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an open-label, dose-escalation study to investigate the safety, tolerability and pharmacokinetics (PK) of single subcutaneous (SC) administration of long acting (LA) Cabotegravir (CAB) 200 milligrams per milliliter (mg/mL) with Recombinant Human Hyaluronidase PH20 (rHuPH20) (Part A), a single-dose or repeat-dose SC or intramuscular (IM) administration of LA CAB (greater than or equal to) \>=400 mg/mL (Part C), single-dose IM administration of LA CAB Formulation I (Part C Cohort C8) and LA CAB Formulation J (Part C Cohort C11), and a single-dose or repeat-dose IM administration of rilpivirine (RPV) (Part E). Part A of the study (CAB 200 mg/mL with rHuPh20) has been closed to further enrolment based on preliminary results. Part D of the study (CAB \>=400 mg/mL with rHuPH20) will not be conducted due to changes in the study design.
CONDITIONS
Official 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...
- Participants aged 18 to 55 years at the time of consent
- Participants must be healthy based on medical history, physical exam, lab tests, and cardiac monitoring
- Body weight must be at least 40 kg and BMI between 18 and 32 kg/m2
- Negative SARS-CoV-2 PCR test on the day of admission
- Men and women must use contraception per local regulations
- Ability to provide written informed consent
You will not qualify if you...
- History or current cardiovascular, respiratory, liver, kidney, gastrointestinal, endocrine, blood, or neurological disorders
- Liver disease or known liver/biliary abnormalities
- Seizure disorder within past 2 years or treatment for seizures in that time
- Positive SARS-CoV-2 test or COVID-19 symptoms or exposure within 14 days before admission
- HIV-1 or HIV-2 infection confirmed by antibody/antigen test
- High-risk behaviors for HIV infection as judged by investigator
- Positive hepatitis B surface antigen or hepatitis C antibody within 3 months before dosing
- Abnormal blood pressure or prior heart attack
- Heart conduction abnormalities or significant arrhythmias
- Abnormal ECG screening results
- ALT levels above 1.5 times upper limit of normal
- Bilirubin above 1.5 times upper limit of normal unless fractionated direct bilirubin is below 35%
- Estimated glomerular filtration rate below 60 mL/min
- Low hemoglobin (below 12.5 g/dL for men, below 11 g/dL for women)
- Positive drug or alcohol screen before study
- Regular tobacco or nicotine use within 3 months or positive cotinine test
- Regular alcohol use exceeding 14 units/week for males or 7 units/week for females within 6 months
- Regular drug abuse
- Participation in another clinical trial or investigational product use within 30 days or longer as specified
- Blood loss exceeding 500 mL within 56 days due to study participation
- Exposure to more than four new chemical entities within 12 months
- Sensitivity or allergy to study drugs or hyaluronidase
- Need for chronic anti-coagulation therapy
- Hereditary bleeding or platelet disorders
- Tattoos or skin conditions at injection sites that interfere with treatment or assessments
- Any condition or behavior making study participation or compliance unsuitable as judged by investigator
- Significant suicide risk based on participant history or investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
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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