Phase
Condition
Hiv Infections
Treatment
VH4011499
VH4011499 Dose A
VH4011499 Dose B
Clinical Study ID
Ages 18-55 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants who are 18 to 55 years of age.
Participants who are overtly healthy.
One SARs-CoV-2 negative test is required prior to dosing
Body weight within 50-100 kg and body mass index (BMI) within the range 19-32 kg/m2 (inclusive).
Capable of giving signed informed consent.
Participants male at birth must use male condoms, and participants female at birthwho are of childbearing potential must be using acceptable forms of birth control.
Exclusion
Exclusion Criteria:
History or presence of disorders capable of significantly altering the absorption,metabolism, or elimination of drugs.
Current or chronic liver disease, hepatic or biliary abnormalities, or relevanthepatitis.
Abnormal blood pressure.
Any malignancy within the past 5 years except certain localized malignancies, orbreast cancer within the past 10 years. Participants with exclusionaryelectrocardiogram findings.Positive HIV test or ongoing behaviors that put theparticipant at high risk for HIV acquisition.
Participants who are breastfeeding or plan to become pregnant during the study.
Past or intended use of exclusionary medications or vaccines.
Exposure to >4 new investigational products within 12 months, previous participationin this study, or current enrolment or participation in another investigationalstudy.
ALT >1.5x upper limit of normal (ULN), total bilirubin >1.5x ULN, and/or estimatedserum creatinine clearance <60 mL/min.
History of or current infection with hepatitis B or hepatitis C.
Positive SARS-CoV-2 test, having signs and symptoms suggestive of COVID-19, orcontact with known COVID-19 positive person.
Positive HIV antibody test.
Participants with positive results for illicit drug use, regular use of drugs ofabuse, tobacco or nicotine-containing product use, and/or excessive alcohol use.
Study Design
Connect with a study center
GSK Investigational Site
Austin, Texas 78744 -1645
United StatesSite Not Available

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