A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants

• Status: Not yet recruiting
• Trial end date: 2024-05-16
• Target enrollment: 0
• Participant gender: All

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) CAB200 or CAB400 with Recombinant Human Hyaluronidase PH20 (rHuPH20) (Parts A or B respectively).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: ViiV Healthcare
• Treatments: Cabotegravir

Criteria

Inclusion Criteria:

• At the time of obtaining informed consent, participants age should be equal to or greater than (=>)18 years and equal to or less than (=<) 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 two (2) consecutive tests for SARS-CoV-2, one performed prior to admission to the Phase 1 unit (up to Day 7 prior to admission) and one prior to dosing, i.e., on Day -1 or 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, haematological, 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.

• Signs and symptoms which, in the opinion of the investigator, are suggestive of COVID-19 (e.g., fever, cough) within 14 days prior to screening; and/or contact with known COVID-19 positive person(s) in the 14 days prior to screening.

• Human immunodeficiency virus (HIV-1 or HIV-2) infection as indicated by positive antibody/antigen test.

• History of or on-going high-risk behaviours 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%).

• Estimated Glomerular Filtration Rate (eGFR) <60 milliliter per minute (mL/min) using the CKD-EPI Creatinine Equation (2021).

• Haemoglobin <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., haemophilia 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.