A phase 1- clinical trial to evaluate the safety, tolerability, pharmacokinetics and tolerability of combinations of monoclonal antibodies VRC01.23LS, PGT121.414.LS, and PGDM1400LS administered via intravenous infusion in adults without HIV
Study Details
A phase 1 clinical trial to evaluate the safety, tolerability, and pharmacokinetics of monoclonal antibodies VRC01.23LS, PGT121.414.LS and PGDM1400LS administered via intravenous infusion in adults without HIV
Multicenter, randomized, open-label study
About 77 adult volunteers without HIV aged 18 through 50 years in the Republic of South Africa
77 participants
6 months per participant in Part A and 12 months per participant in Part B of scheduled clinic visits. 22 months (includes enrollment, planned safety holds, and follow-up)
Part A
Group 1, VRC01.23LS, 5 mg/kg
Group 2, VRC01.23LS, 20 mg/kg
Group 3, VRC01.23LS, 40 mg/kg IV
Part B
Group 4, VRC01.23LS + PGT121.414.LS + PGDM1400LS, 5 + 5 + 5 mg/kg IV
Group 5, VRC01.23LS + PGT121.414.LS + PGDM1400LS, 20 + 5 + 5 mg/kg IV
Group 6, VRC01.23LS + PGT121.414.LS + PGDM1400LS, 20 + 20 + 20 mg/kg IV
Group 7, VRC01.23LS + PGT121.414.LS + PGDM1400LS, 40 + 5 + 5 mg/kg IV
Group 8, VRC01.23LS + PGT121.414.LS + PGDM1400LS, 40 + 40 + 40 mg/kg IV*
• To evaluate the safety and tolerability of VRC01.23LS when administered alone via intravenous (IV) route (Part A) and of VRC01.23LS + PGT121.414.LS + PGDM1400LS, when administered consecutively via IV route (Part B)
• To evaluate the serum concentrations and pharmacokinetics (PK) of VRC01.23LS when administered alone via IV (Part A) and of VRC01.23LS + PGT121.414.LS + PGDM1400LS, after consecutive administration via IV route (Part B)
• To evaluate the individual mAb-specific serum neutralizing activity of VRC01.23LS when administered alone via IV (Part A) and of VRC01.23LS + PGT121.414.LS + PGDM1400LS, after consecutive administration via IV route (Part B)