Assessment of Bezlotoxumab Immunogenicity.

Autor: Montgomery, Diana L., Matthews, Randolph P., Yee, Ka Lai, Tobias, Lori M., Dorr, Mary Beth, Wrishko, Rebecca E.
Předmět:
Zdroj: Clinical Pharmacology in Drug Development; Apr2020, Vol. 9 Issue 3, p330-340, 11p
Abstrakt: Bezlotoxumab is a fully human monoclonal antibody that binds and neutralizes Clostridium difficile toxin B. This analysis investigated the potential of bezlotoxumab to induce immunogenicity in healthy phase 1 trial participants and in phase 2/3 trial participants receiving oral antibacterial therapy for primary or recurrent C difficile infection. Immunogenicity to bezlotoxumab was evaluated following a single intravenous dose (≤20 mg/kg) or 2 consecutive doses (10 mg/kg) given 84 days apart in healthy participants across 3 phase 1 trials (Protocol MK‐3415A‐004, N = 30; Protocol CA‐GCDX‐05‐01, N = 54; Protocol MK‐3415A‐006, N = 12) and following a single 10 mg/kg dose in 1 phase 2 trial (Protocol CA‐GCDX‐06‐02, ClinicalTrials.gov identifier: NCT00350298; N = 97) and 2 phase 3 trials (Protocols MK‐3415A‐001 and MK‐3415A‐002, ClinicalTrials.gov identifiers: NCT01241552 and NCT01513239; N = 1414). No treatment‐emergent antidrug antibodies were observed following single or repeated dosing of bezlotoxumab. No phase 1 participants and only 1 phase 2 participant tested positive before bezlotoxumab exposure (non–treatment‐emergent positive). Nine participants tested non–treatment‐emergent positive in phase 3 trials, 1 of whom was neutralizing antibody–positive. Overall, the immunogenicity potential of bezlotoxumab is considered to be low. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index
Externí odkaz:
Nepřihlášeným uživatelům se plný text nezobrazuje