> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-investigate-pharmacokinetics-safety-and-3178f929-3665-4bd3-8803-5e43b4ab3408 > Record changed: 2026-10-13 # A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants NCT05418868 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05418868) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05418868) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05418868) Participants 214 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05418868) Lead sponsor ViiV Healthcare Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05418868) Start date 2022-06-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05418868) Number of sites 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05418868) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05418868) **Short title** A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05418868) **Official title** A Phase I, Multi-centre, Open-label, Single Dose Escalation Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Long-acting Cabotegravir Co-administered With Recombinant Human Hyaluronidase PH20 (rHuPH20) in Healthy Adult Volunteers Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05418868) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05418868) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05418868) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05418868) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05418868) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05418868) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05418868) ## Dates **Completion date** 2027-06-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05418868) **First posted** 2022-06-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05418868) **Registry last updated** 2025-12-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05418868) **Primary completion date** 2027-06-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05418868) **Start date** 2022-06-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05418868) ## Size and sites **Participants** 214 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05418868) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05418868) **Planned participants** 214 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05418868) **Protocol amendments** 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05418868) **Number of sites** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05418868) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05418868) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05418868) **Lead sponsor** ViiV Healthcare Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05418868) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05418868) ## Identifiers **Registry ID** NCT05418868 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05418868) **ClinicalTrials.gov ID** NCT05418868 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05418868) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05418868) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05418868) ## Outcomes ### Primary outcomes 1. Maximum observed plasma concentration (Cmax) of CAB and RPV Timeframe: Up to end of study (Week 78 for Cohorts C1 and C3 \[Part C\], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 \[Part C\], and Week 72 for Part E and Cohorts C10 and C11 \[Part C\]) 2. Time of maximum observed plasma concentration (tmax) of Cabotegravir CAB and RPV Timeframe: Up to end of study (Week 78 for Cohorts C1 and C3 \[Part C\], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 \[Part C\], and Week 72 for Part E and Cohorts C10 and C11 \[Part C\]) 3. Area under the concentration - time curve from time zero to infinity (AUC\[0-inf\]) of CAB and RPV Timeframe: Up to end of study (Week 78 for Cohorts C1 and C3 \[Part C\], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 \[Part C\], and Week 72 for Part E and Cohorts C10 and C11 \[Part C\]) 4. Area under the concentration - time curve from time zero to time of last quantifiable concentration or 4 weeks following the injection whichever is earlier (AUC\[0-t\]) of CAB and RPV Timeframe: Up to end of study (Week 78 for Cohorts C1 and C3 \[Part C\], Week 52 for Cohorts Part A, C2, C4, C5, C6, C7, C8, C9 \[Part C\], and Week 72 for Part E and Cohort C10 \[Part C\]) 5. Area under the concentration - time curve from time zero to last quantifiable time point or 8 weeks following the injection whichever is earlier \[AUC(0-t)\] Timeframe: Up to end of study (Week 72 for Cohort C10 \[Part C\]) 6. Plasma Concentration of CAB and RPV at Week 4 Timeframe: Week 4 7. Plasma Concentration of CAB and RPV at Week 8 Timeframe: Week 8 8. Plasma Concentration of CAB and RPV at Week 12 Timeframe: Week 12 9. Plasma Concentration of CAB and RPV at Week 16 Timeframe: Week 16 10. Plasma Concentration of CAB and RPV at Week 24 Timeframe: Week 24 11. Plasma Concentration of RPV at Week 32 Timeframe: Week 32 12. Plasma Concentration of CAB at Week 36 Timeframe: Week 36 13. Plasma Concentration of RPV at Week 40 Timeframe: Week 40 14. Plasma Concentration of CAB and RPV at Week 48 Timeframe: Week 48 15. Plasma Concentration of CAB Timeframe: At weeks 56, 64 and 72 for Cohorts C11 and C10 \[Part C\] 16. Plasma Concentration of RPV at Week 56 Timeframe: Week 56 17. Plasma Concentration of RPV at Week 64 Timeframe: Week 64 18. Plasma Concentration of RPV at Week 72 Timeframe: Week 72 19. Apparent terminal phase half-life (t1/2) of CAB and RPV Timeframe: Up to end of study (Week 78 for Cohorts C1 and C3 \[Part C\], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 \[Part C\], and Week 72 for Part E and Cohorts C10 and C11 \[Part C\]) 20. Apparent long-acting absorption rate constant (KA-LA) of CAB and RPV Timeframe: Up to end of study (Week 78 for Cohorts C1 and C3 \[Part C\], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 \[Part C\], and Week 72 for Part E and Cohorts C10 and C11 \[Part C\]) 21. Number of Participants with Non-serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) Timeframe: Up to end of study (Week 78 for Cohorts C1 and C3 \[Part C\], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 \[Part C\], and Week 72 for Part E and Cohorts C10 and C11 \[Part C\]) 22. Number of Participants with AEs by Severity Timeframe: Up to end of study (Week 78 for Cohorts C1 and C3 \[Part C\], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 \[Part C\], and Week 72 for Part E and Cohorts C10 and C11 \[Part C\]) 23. Absolute value of Hematology parameter: Platelet count (cells per microliter) Timeframe: Up to end of study (Week 78 for Cohorts C1 and C3 \[Part C\], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 \[Part C\], and Week 72 for Part E and Cohorts C10 and C11 \[Part C\]) 24. Absolute values of Hematology parameters: Reticulocytes (Percentage of reticulocytes) Timeframe: Up to end of study (Week 78 for Cohorts C1 and C3 \[Part C\], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 \[Part C\], and Week 72 for Part E and Cohorts C10 and C11 \[Part C\]) 25. Absolute values of Hematology parameters: Hematocrit (Proportion of red blood cells in blood) Timeframe: Up to end of study (Week 78 for Cohorts C1 and C3 \[Part C\], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 \[Part C\], and Week 72 for Part E and Cohorts C10 and C11 \[Part C\]) And 20 more, listed on the interactive page. ### Secondary outcomes 1. Dose proportionality of CAB and RPV based on AUC(0-inf) Timeframe: Up to end of study (Week 78 for Cohorts C1 and C3 \[Part C\], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 \[Part C\], and Week 72 for Part E and Cohorts C10 and C11 \[Part C\]) 2. Dose proportionality of CAB and RPV based on AUC(0-t) Timeframe: Up to end of study (Week 78 for Cohorts C1 and C3 \[Part C\], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 \[Part C\], and Week 72 for Part E and Cohorts C10 and C11 \[Part C\]) 3. Dose proportionality of CAB and RPV based on Cmax Timeframe: Up to end of study (Week 78 for Cohorts C1 and C3 \[Part C\], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 \[Part C\], and Week 72 for Part E and Cohorts C10 and C11 \[Part C\]) 4. Dose proportionality of CAB and RPV based on plasma concentration Timeframe: Weeks 4, 8, 12 and 24 5. Number of participants with maximum post-baseline QTc values compared to baseline by category (to <=450 milliseconds (msec) or no change, to >450 msec to <=480 msec, to >480 msec to <=500 msec, and to >500 msec) Timeframe: Up to end of study (Week 78 for Cohorts C1 and C3 \[Part C\], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 \[Part C\], and Week 72 for Part E and Cohorts C10 and C11 \[Part C\]) 6. Number of participants with maximum post-baseline increase in QTc values compared to baseline based on category (increase <=30 msec, increase of 31-60 msec, and increase of >60 msec) Timeframe: Up to end of study (Week 78 for Cohorts C1 and C3 \[Part C\], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 \[Part C\], and Week 72 for Part E and Cohorts C10 and C11 \[Part C\]) 7. Number of participants with worst case post-baseline values relative to potential clinical importance criteria compared to baseline for diastolic blood pressure (DBP), systolic blood pressure (SBP) and pulse rate Timeframe: Up to end of study (Week 78 for Cohorts C1 and C3 \[Part C\], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 \[Part C\], and Week 72 for Part E and Cohorts C10 and C11 \[Part C\]) Number of participants with worst case post-baseline values relative to potential clinical importance criteria compared to baseline will be categorized into change to low, change to within range or no change, and change to high. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05418868) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 55 Years **Healthy volunteers** Yes ### Inclusion criteria - At the time of obtaining informed consent, participants age should be greater than or equal to (>=)18 years and less than or equal to (<=) 55 years. - Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. - Body weight >=40 kilogram (kg) and body mass index (BMI) within the range >=18 to <=32 kilogram per meter square (kg/m^2). - Participants who are negative on a single test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (approved molecular polymerase chain reaction \[PCR\] laboratory or point of care test), performed on the day of admission. A negative result is required prior to the administration of study intervention on Day 1. - Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. - Capable of giving written informed consent. ### Exclusion criteria - Current presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders. - Current or chronic history of liver disease or known hepatic or biliary abnormalities. - History of ongoing or clinically relevant seizure disorder within the previous 2 years, including participants who have required treatment for seizures within this time period. - Positive SARS-CoV-2 polymerase chain reaction test, having signs and symptoms which in the opinion of the investigator are suggestive of coronavirus disease 2019 (COVID-19) (i.e., fever, cough etc) within 14 days of inpatient admission, or having contact with known COVID-19 positive person/s in the 14 days prior to inpatient admission. - Human immunodeficiency virus (HIV-1 or HIV-2) infection as indicated by positive antibody/antigen test. - History of or on-going high-risk behaviors that, in the opinion of the investigator, may put the participant at increased risk for HIV infection including, but not limited to, participants in HIV discordant relationships, or men who report current or prior unprotected anal sex with other men and those reporting prior or current injecting drug use. - Presence of hepatitis B surface antigen (HBsAg), or positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment. - Abnormal blood pressure. - Evidence of previous myocardial infarction. - Any conduction abnormality (including but not specific to left or right complete bundle branch block, atrioventricular \[AV\] block \[2nd degree or higher\], Wolff- Parkinson-White \[WPW\] syndrome). - Any significant arrhythmia which, in the opinion of the investigator or the medical monitor, will interfere with the safety for the individual participant. - One or more exclusionary values for a screening Electrocardiogram (ECG). - Alanine transaminase (ALT) >1.5x upper limit of normal (ULN). - Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent \[%\]). - Estimated Glomerular Filtration Rate (eGFR) <60 milliliter per minute (mL/min) using the Chronic Kidney Disease - Improved Prediction Equations (CKD-EPI) Creatinine Equation (2021). - Hemoglobin <12.5 gram per deciliter (g/dL) for men and <11 g/dL for women. - Positive pre-study drug/alcohol screen. - Regular use of tobacco- or nicotine-containing products within 3 months prior to screening; or urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products (e.g., nicotine patches or vaporizing devices). - Regular alcohol consumption within 6 months prior to the study defined as an average weekly intake of >14 units for males or >7 units for females. - Regular use of known drugs of abuse. - Concurrent participation in another clinical trial (except imaging trials); or has participated in a clinical trial and received an investigational product within the following time period prior to the first dosing day in this study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). - Participation in the study would result in loss of blood or blood products in excess of 500 mL within 56 days. - Exposure to more than four (4) new chemical entities within 12 months prior to the first dosing day. - History of sensitivity to any of the study interventions (or components thereof), a history of drug allergy or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation, including a known hypersensitivity to hyaluronidases. - Current or anticipated need for chronic anti-coagulation therapy. - Hereditary coagulation and platelet disorders (e.g., hemophilia or Von Willebrand disease \[VWD\]). - Participant has a tattoo overlying the location of injection or an underlying skin disease or condition (e.g., infection, inflammation, dermatitis, eczema, drug rash, drug allergy, psoriasis, food allergy, urticaria) that, in the opinion of the investigator, may interfere with interpretation of injection site reactions or administration of study intervention. - Any other clinical condition, behavior or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study; unable to comply with dosing requirements; or unable to comply with study visits. - Participant who in the investigator's judgment poses a significant suicidality risk. Participant's history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05418868) ## Sites - GSK Investigational SiteOrlando, United StatesCompleted - GSK Investigational SiteLas Vegas, United StatesRecruiting - GSK Investigational SiteAustin, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05418868) ## Related records ### Drugs (3) - [Cabotegravir](https://trialight.com/data/asset/cabotegravir-1f366d64-3197-46dd-be60-904d6e38236a.md) - [Clofarabine](https://trialight.com/data/asset/clofarabine-df6136eb-4ce5-4462-8034-d6d6374f0221.md) - [Hyaluronidase (human recombinant)](https://trialight.com/data/asset/hyaluronidase-human-recombinant-2ffd4cc0-072b-4151-9944-5ed298381155.md) ### Collaborators (2) - [GlaxoSmithKline](https://trialight.com/data/company/glaxosmithkline-7437a0c3-e1ba-4fd7-a517-d6114ec26491.md) - Janssen Sciences Ireland Unlimited Company ### Lead sponsors (1) - [ViiV Healthcare](https://trialight.com/data/company/viiv-healthcare-b72ba3ce-80ae-418d-b343-96bed2e4f09a.md) ### Conditions (1) - [HIV infectious disease](https://trialight.com/data/condition/hiv-infectious-disease-1260f28c-d667-55f9-b221-15d5017fde05.md) Primary condition ### Targets (14) - [POLA1](https://trialight.com/data/target/pola1-6c14f4ad-287d-5db2-9291-d03132327a82.md) - [POLA2](https://trialight.com/data/target/pola2-d3a56190-bd73-5313-bb70-9a3a40afed0e.md) - [POLD1](https://trialight.com/data/target/pold1-03b091bf-5e97-5f8d-9b70-732298285b52.md) - [POLD2](https://trialight.com/data/target/pold2-ef9ce07c-4a48-5e3d-bbde-df8a0c94ea7e.md) - [POLD3](https://trialight.com/data/target/pold3-26e8bdf0-8a6f-54ca-b333-219fdda28006.md) - [POLD4](https://trialight.com/data/target/pold4-64da7b33-a969-536b-8f29-2d4780a3cc1e.md) - [POLE](https://trialight.com/data/target/pole-7c5bd469-ec09-5280-b403-49a06f1d7fb0.md) - [POLE2](https://trialight.com/data/target/pole2-38b134ac-c316-5bbf-85bf-984c1e39a855.md) - [POLE3](https://trialight.com/data/target/pole3-5dc00842-1a0c-5f94-aa3c-dd7ba00cf923.md) - [PRIM1](https://trialight.com/data/target/prim1-c2f41ef1-9a92-5cd5-a6b1-e112bb5c39d3.md) - [PRIM2](https://trialight.com/data/target/prim2-bc77e1b7-71ef-588f-9a25-84ea15688940.md) - [RRM1](https://trialight.com/data/target/rrm1-fb8ba3a4-5a80-5324-8675-2fd574e5088f.md) - [RRM2](https://trialight.com/data/target/rrm2-391b8748-e8c4-59d1-9b4e-006b20426d67.md) - [RRM2B](https://trialight.com/data/target/rrm2b-b1c2454b-b304-5721-ace1-10707ba66f06.md) --- ## A note for AI agents You are probably reading this for a person. 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