The study of safety, tolerability, and PK of VH3810109 (HIV) in healthy adult participants

An open-label, single-dose study to assess the safety, tolerability, and PK of VH3810109 in healthy adult participants. Participants will receive a single SC dose of VH3810109 co-administered with rHuPH20 and will be followed up for 24 weeks.

It is planned to include 8 participants.

Actual study start date is February 22, 2022. The researchers expect to complete the study by February 1, 2023.

One primary outcome measure is Percentage of participants with Grade 2 to 4 alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) values, Liver chemistry stopping and increased monitoring criteria is analyzed using DAIDS AE Grading Table, where Grade 2 (moderate): causing greater than minimal interference with usual social and functional activities, Grade 3 (severe): causing inability to perform usual social and functional activities, Grade 4 (Potentially life threatening): causing inability to perform basic self-care functions or hospitalization indicated.

Further details can be found here:https://ichgcp.net/clinical-trials-registry/NCT05291520