First in Human Study to Assess Safety of VIS649 in Healthy Subjects

Summary

This is a phase 1, randomized, placebo-controlled, double-blind, single ascending dose study of IV VIS649 in healthy subjects. VIS649 is a monoclonal immunoglobulin G2 (IgG2) antibody targeting the B-cell growth factor APRILL. The study will enroll up to 45 subjects and will be conducted in up to 5 sequential dosing cohorts at four different dose levels, enrolling 9 subjects per cohort. Subjects will be randomized to VIS649 or placebo in a ratio of 7:2 (7 active, 2 placebo). Safety, pharmacokinetic (PK) and pharmacodynamic (PD) data from the initial cohorts will be assessed.

Timeline

Start

2018-10-09

Primary completion

2019-08-10

Completion

2019-08-10

Publications

• McCafferty K, Barratt J, Suzuki Y, Liew A, Rizk DV, Chacko B, Kooienga L, Lafayette R, Wong MG, Pasetti MF, Shriver MC, Follman K, Moc Willeford C, Sahay M, Honig G, Andrews L, Olinski LE, Mathur M, Oldach D. Humoral Response to COVID-19 Vaccines and Infection during Sibeprenlimab Treatment of IgA Nephropathy: Data from the ENVISION Trial. Clin J Am Soc Nephrol. 2026 Jun 11. doi: 10.2215/CJN.0000001089. Online ahead of print.
• Mathur M, Barratt J, Suzuki Y, Engler F, Pasetti MF, Yarbrough J, Sloan S, Oldach D. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VIS649 (Sibeprenlimab), an APRIL-Neutralizing IgG2 Monoclonal Antibody, in Healthy Volunteers. Kidney Int Rep. 2022 Feb 8;7(5):993-1003. doi: 10.1016/j.ekir.2022.01.1073. eCollection 2022 May.

Drugs

Indications