This study will assess the pharmacokinetics (PK), safety, and tolerability of CAB ULA administered every 4 months (Q4M) following administration of CAB LA every 2 months (Q2M), in healthy adult volunteers.
The participants in the study will receive CAB LA in the CAB LA phase and CAB ULA in the CAB ULA phase.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
69
GSK Investigational Site
Mobile, Alabama, United States
GSK Investigational Site
Coral Gables, Florida, United States
GSK Investigational Site
Oak Brook, Illinois, United States
Plasma concentration of CAB at the end of the CAB LA phase compared to plasma concentration of CAB at the end of the CAB ULA phase
Time frame: At Month 23 compared to Month 9
Plasma concentration of CAB at each assessment timepoint following CAB ULA injections
Time frame: Up to Month 23
Number of participants with adverse events (AEs) (including Injection Site Reactions [ISRs]) as per severity
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Severity is graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening.
Time frame: Up to Month 32
Number of participants with laboratory abnormalities
Time frame: Up to Month 32
Number of participants with changes in laboratory parameters over time
Time frame: Up to Month 32
Number of participants with ISRs by grade
Severity of ISRs is graded according to the DAIDS grading criteria, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening
Time frame: Up to Month 32
Duration (Days) of ISRs by grade
Severity of ISRs is graded according to the DAIDS grading criteria, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening.
Time frame: Up to Month 32
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