First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4011499 in Healthy Participants

• Status: Not yet recruiting
• Trial end date: 2023-01-19
• Target enrollment: 0
• Participant gender: All

Summary

This FTIH study aims to evaluate the safety, tolerability and PK of the novel investigational Human immunodeficiency virus (HIV)-1 capsid inhibitor VH4011499 in healthy adults. The study will be conducted in 2 parts: Part 1 will investigate single ascending doses (SAD) and Part 2 will investigate multiple ascending doses (MAD). The transition from SAD to MAD will be based on the assessment of the Safety and Dose Escalation Committee.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: ViiV Healthcare

Criteria

Inclusion Criteria:

• Participants who are overtly healthy.

• Participants must have two consecutive SARs-CoV-2 PCR negative results prior to dosing.

• Participants must have body weight > 50 kilograms (kg) and body mass index (BMI) within the range 19-32 kilograms per meter square (kg/m^2)

• Male or female participants of non-childbearing potential.

• Capable of giving signed informed consent.

Exclusion Criteria:

• History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neurological or psychiatric disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study drug or interfering with the interpretation of data.

• Abnormal blood pressure.

• Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.

• Breast cancer within the past 10 years.

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

• QT interval corrected for heart rate according to Fridericia's formula (QTcF) greater than (>)450 milliseconds (msec).

• Past or intended use of over-the-counter or prescription medication including herbal medications within 7 days prior to dosing.

• Live vaccine(s) within 1 month prior to screening or plans to receive such vaccines during the study.

• Exposure to more than 4 investigational products within 12 months prior to dosing.

• Current enrollment or recent past participation in another investigational study.

• ALT >1.5 times upper limit of normal (ULN), total bilirubin >1.5 times ULN, and/or estimated serum creatinine clearance less than 60 milliliters per minute.

• History of or current infection with hepatitis B or hepatitis C.

• Positive Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) test, having signs and symptoms, or having contact with known Coronavirus Disease-2019 (COVID-19) positive person/s.

• Positive HIV antibody test.

• User of tobacco or nicotine-containing products, regular alcohol consumption and/or regular use of known drugs of abuse.

• Sensitivity to the study drug, or components thereof.