TMB-108
Status:Completed
Phase:I
Principal Investigator(s):Stanley T Lewis
Objective:Blinded safety study of ibalizumab given by subcutaneous injection in sequentially increasing dose-groups of at-risk, HIV-negative, healthy volunteers. The study involves the administration of four total injections of ibalizumab or matching placebo in each volunteer, given once every week, at one of three dose levels. Drug administration begins at the lowest dose. After 4 of 8 volunteers in the first group have received all study drug injections and have completed 6 additional weeks of follow-up, an independent safety monitoring group will review available data before approving initiation of the next higher dose-group. This process will be repeated prior to initiation of the 3rd and highest dose-group.All volunteers will participate in 2 separate intensive blood sampling periods of 7 days each to test drug levels.
Prevention Option(s):HIV Vaccine
Study Design:Double-blind, Randomized
Arms and Assigned Interventions
Description120 mg ibalizumab administered by subcutaneous injection weekly for 4 weeks, randomized 6:2 with placebo
Mode of DeliverySubcutaneous
ARMsExperimental
Description240 mg ibalizumab administered by subcutaneous injection weekly for 4 weeks, randomized 6:2 with placebo
Mode of DeliverySubcutaneous
ARMsExperimental
Description480 mg ibalizumab administered by subcutaneous injection weekly for 4 weeks, randomized 6:2 with placebo
Mode of DeliverySubcutaneous
ARMsExperimental
Official Code:
NCT01292174
Trial Sponsors:
Aaron Diamond AIDS Research Center, Bill & Melinda Gates Foundation, TaiMed Biologics Inc.
Start Date
End Date
February 1, 2011
September 30, 2015
Enrollment:25
Age range:
18 Years ↔
40 Years
Population:Cisgender Men, Cisgender Women