This study evaluates the PK, safety, and tolerability of a single increasing dose of VH4367310, a cabotegravir (CAB) prodrug, when administered intramuscularly in healthy adult participants 18 to 55 years of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
112
Area under the concentration time curve from time zero to last quantifiable time point (AUC0-tlast) of VH4367310 and CAB
Time frame: Up to Week 72
Maximum observed plasma concentration (Cmax) of VH4367310 and CAB
Time frame: Up to Week 72
Time to maximum observed plasma concentration (Tmax) of VH4367310 and CAB
Time frame: Up to Week 72
Number of participants with drug-related adverse events (AEs)
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.
Time frame: Up to Week 72
Number of participants with AEs as per severity
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, Grade 5 = Death.
Time frame: Up to Week 72
Number of participants with drug-related serious adverse events (SAEs)
An SAE is defined as any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongs existing hospitalization, results in disability/incapacity or other medically significant events.
Time frame: Up to Week 72
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