RO7565020 / Roche - LARVOL DELTA

Safety, tolerability, pharmacokinetics, and pharmacodynamics of RO7565020, a novel monoclonal antibody that targets the hepatitis B surface antigen: results from a phase 1 single ascending dose study in healthy volunteers and participants with chronic hepatitis B (EASL 2025) - P1 | "Background and Aims: RO7565020 (RG6449) is a neutralizing human IgG1 monoclonal antibody (mAb) targeting the antigenic loop present in all forms of hepatitis B surface antigen (HBsAg). RO7565020 administered as a single dose was generally safe and well-tolerated. It demonstrated proof-of-mechanism with rapid reductions in serum HBsAg in participants with CHB who had baseline HBsAg ≤ 3000 IU/mL."

Clinical • P1 data • PK/PD data • Hepatitis B • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation

A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - P1 | N=60 | Terminated | Sponsor: Hoffmann-La Roche | N=110 ➔ 60 | Trial completion date: May 2026 ➔ Dec 2024 | Recruiting ➔ Terminated | Trial primary completion date: May 2026 ➔ Dec 2024; The Sponsor decided to discontinue the development of RO7565020 and as a result the BP44118 study was terminated.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - P1 | N=110 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Feb 2027 ➔ May 2026 | Trial primary completion date: Feb 2027 ➔ May 2026

Trial completion date • Trial primary completion date • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - P1 | N=110 | Recruiting | Sponsor: Hoffmann-La Roche | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - P1 | N=110 | Not yet recruiting | Sponsor: Hoffmann-La Roche

New P1 trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation