A Study to Investigate if Long Acting Cabotegravir (CAB) and Lenacapavir (LEN) Injections Are Tolerable and Acceptable When Administered to Healthy Adults Without HIV

Inclusion Criteria:

Participants are eligible to be included in the study only if all the following criteria apply:

1. At the time of obtaining informed consent, 18 years of age.

2. Body weight 50 kg and BMI within the range 18 to 32 kg/m2 (inclusive).

3. Participants who are overtly healthy as determined by medical evaluation by aresponsible and experienced physician, including medical history, physicalexamination, laboratory tests and cardiac monitoring.

4. A participant with a significant clinical abnormality or laboratory parameter(s)which is/are not specifically listed in the inclusion or exclusion criteria, outsidethe reference range for the population being studied may be included if theinvestigator determines and documents that the finding is unlikely to introduceadditional risk factors and will not interfere with the study procedures. A singlerepeat of a procedure or lab parameter is allowed to determine eligibility.

5. Male or female at birth (transgender individuals are not excluded but LEN mayinterfere with gender affirming hormones including increasing thrombotic risk. Thisshould be discussed with Medical Monitor).

6. All participants are expected to use barrier methods for HIV/STI prevention andshould be counselled accordingly at all visits.

7. Contraceptive use by men and women should be consistent with local regulationsregarding the methods of contraception for those participating in clinical studies.

8. Participants assigned female at birth are eligible to participate if they are notpregnant or breast/chest-feeding, and at least 1 of the following conditionsapplies:

• Is not a person of childbearing potential (POCBP) OR

• Is a POCBP and using a contraceptive method that is highly effective, with afailure rate of <1%. The investigator should evaluate the effectiveness of thecontraceptive method in relationship to the first dose of study intervention.

9. A POCBP must have a negative highly sensitive pregnancy test (urine and/or serum asrequired) within the 21 days before the dose of study intervention.

10. Must be capable of giving written informed consent, which includes compliance withthe requirements and restrictions listed in the informed consent form (ICF) and inthis protocol.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

1. History or presence of cardiovascular, respiratory, hepatic, renal,gastrointestinal, endocrine, hematologic, or neurological disorders capable ofsignificantly altering the absorption, metabolism, or elimination of drugs;constituting a risk when taking the study intervention or interfering with theinterpretation of data. The investigator may contact the ViiV healthcare (VH)medical monitor to discuss the inclusion of participants who have a history ofspecific conditions that are not expected to interfere with their participation inthe study.

2. Suspected or known active, serious infection(s).

3. Abnormal blood pressure as determined by the investigator.

4. History of any malignancy within the past 5 years. Exceptions are squamous and basalcell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy whichis considered cured with minimal risk of recurrence. Participants under evaluationfor possible malignancy are not eligible.

5. Breast cancer within the past 10 years

6. Current or chronic history of liver disease or known hepatic or biliaryabnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).

7. The participant has an underlying skin disease or disorder (i.e., infection,inflammation, dermatitis, eczema, drug rash, drug allergy, psoriasis, food allergy,urticaria) that would interfere with assessment of injection sites.

8. Current or anticipated need for chronic anti-coagulation.

9. Participants considered to have insufficient musculature to allow safe intramuscular (e.g., gluteus medius, vastus lateralis) or sufficient subcutaneous thickness toallow subcutaneous administration in the opinion of the investigator.

10. Any Positive Treponeme Specific Serologic testing (positive T. Pallidum antibodyimmunoassay + Rapid plasma reagin [RPR] or positive T. Pallidum antibody immunoassay

• Treponema pallidum particle agglutination [TPPA]) is exclusionary.

11. Presence of HBsAg, or positive hepatitis C antibody test result at Screening orwithin 3 months prior to first dose of study treatment.

12. Have a history of osteoporosis or bone fragility fractures.

13. Participants who, in the investigator's judgment, poses a significant suicidalityrisk. Participant's history of suicidal behaviour and/or suicidal ideation should beconsidered when evaluating for suicide risk.

14. Any preexisting physical or mental condition which, in the opinion of theInvestigator or the Medical Monitor, may interfere with the participant's ability tocomply with the dosing schedule and/or protocol evaluations or which may compromisethe safety of the participant.

15. Participants receiving any protocol-prohibited medication and who are unwilling orunable to switch to an alternate medication.

16. Treatment with any of the following agents within 60 days of screening: radiationtherapy, cytotoxic chemotherapeutic agents, any systemic immune suppressant.

17. Past or intended use of over-the-counter or prescription medication including herbalmedications within 7 days prior to dosing.

18. Use of glucocorticoids (through any route).

19. Exposure to more than 4 new investigational products within 12 months prior to thefirst dosing day.

20. Current enrolment or past participation in another investigational study in which aninvestigational intervention (e.g., drug, human blood product, monoclonal antibody,vaccine, invasive device) was administered within 1 month, 5 half-lives or twice theduration of the biological effect of the test agent prior to screening (whichever islonger).

21. Any acute laboratory abnormality at Screening, which, in the opinion of theinvestigator, would preclude the participant's participation in the study of aninvestigational compound.

22. Any verified Grade 4 laboratory abnormality, with the exception of Grade 4triglycerides or lipid abnormalities. A single repeat test is allowed during thescreening period to verify a result.

23. ALT greater than or equal to (>=) 1.5x ULN. A single repeat test is allowed within asingle Screening period to determine eligibility.

24. Total bilirubin >=1.5x ULN (isolated total bilirubin greater than [>] 1.5xULN isacceptable if total bilirubin is fractionated and direct bilirubin less than [<] 35%). A single repeat test is allowed within a single screening period to determineeligibility.

25. Creatinine clearance (eGFR) of <60 mL/min/1.73 m2 via CKD-EPI method.

26. Positive HIV antibody/antigen test (HIV-1, HIV-2) at screening or enrolment.Participants will be advised regarding safer sex. In the event a participantacquires HIV during the study they will be required to withdraw from the study andwill be referred urgently to an HIV treatment center for further management.

27. Clinically significant cardiovascular disease, as defined by history/evidence ofcongestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary arterybypass grafting surgery or percutaneous transluminal coronary angioplasty or anyclinically significant cardiac disease.

28. Grade 3 or Grade 4 proteinuria or glycosuria at screening that is unexplained or notclinically manageable.

29. Participant is unlikely to adhere to the study procedures, keep appointments, isplanning to relocate during the study, or remain on study through to its conclusion.

30. Alcohol or substance use that, in the opinion of the study investigator and medicalmonitor, would interfere with the conduct of the study (e.g., provided byself-report, or found upon medical history and examination or in available medicalrecords).

31. Participant has an implant/enhancement (including fillers) at the area of proposedinjection; or tattoo or other dermatological condition overlying the area for IM orSC injection (e.g., gluteus medius, vastus lateralis or anterior abdominal wall) orany other area which may significantly interfere with interpretation of injectionsite reactions.