AZD5148 / AstraZeneca - LARVOL DELTA

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AZD5148 in Healthy Adults (clinicaltrials.gov) - P1 | N=84 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

Trial completion

The monoclonal antibody AZD5148 confers broad protection against TcdB-diverse Clostridioides difficile strains in mice. (PubMed, PLoS Pathog) - "These findings demonstrate that AZD5148 offers broad-spectrum protection against C. difficile strains and retains in vivo efficacy even in the absence of in vitro neutralization. Its distinct mechanism of action and superior potency compared to bezlotoxumab support its continued development as a promising therapeutic candidate for the prevention of a first CDI episode and prevention of recurrence."

Journal • Preclinical • Infectious Disease

Epitope conservation of AZD5148, a broadly neutralizing anti-Toxin B monoclonal antibody, among diverse and global contemporary Clostridioides difficile isolates. (PubMed, J Infect Dis) - "Our comprehensive analysis of global sequences found the AZD5148 epitope to be highly conserved, and thus unlikely to be impacted by most of the genotypic variations in recently circulating C. difficile ribotypes and STs."

Journal • Infectious Disease

Safety and Tolerability of AZD5148 in Japanese Participants (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AZD5148 in Healthy Adults (clinicaltrials.gov) - P1 | N=84 | Active, not recruiting | Sponsor: AstraZeneca | Trial primary completion date: Feb 2025 ➔ Nov 2025

Trial primary completion date

Safety and Tolerability of AZD5148 in Japanese Participants (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AZD5148 in Healthy Adults (clinicaltrials.gov) - P1 | N=84 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

Enrollment closed

Safety and Tolerability of AZD5148 in Japanese Participants (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: AstraZeneca

New P1 trial • Infectious Disease

Anti-Toxin B Neutralizing Monoclonal Antibody AZD5148 Provides Protection in a Clostridioides difficile Gnotobiotic Piglet Model (IDWeek 2024) - No abstract available

Infectious Disease

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AZD5148 in Healthy Adults (clinicaltrials.gov) - P1 | N=84 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AZD5148 in Healthy Adults (clinicaltrials.gov) - P1 | N=84 | Not yet recruiting | Sponsor: AstraZeneca

New P1 trial