Status and phase
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About
This study evaluates the safety, tolerability, and pharmacokinetics (PK) of a single dose administration of VH4527079 by subcutaneous (SC) injection or by intravenous (IV) infusion in healthy adult participants and multiple dose administration by IV infusion in healthy adult participants and in Persons with HIV (PWH).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Participant must be 18 to 55 years of age inclusive at the time of signing the informed consent.
Participants who are overtly healthy based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
Participants who are able to understand and comply with protocol requirements and timetables, instructions, and protocol-stated restrictions.
For Cohort 9 (PWH in Arm B), well controlled HIV on first-line INSTI-based oral antiretroviral therapy without history of virologic failure (will be continued during study).
Body weight more than or equal to (>=)50.0 kg for men and >=45.0 kg for women and Body Mass Index (BMI) within the range 18.5 to 31.0 kg/m^2.
Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Capable of giving signed informed consent.
Willing to have samples stored for future research for participants in Arm B; Cohort 8 (Healthy Volunteers) and Cohort 9 (PWH in Arm B).
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
86 participants in 9 patient groups
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Central trial contact
EU GSK Clinical Trials Call Center; US GSK Clinical Trials Call Center
Data sourced from clinicaltrials.gov
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