drugset / Trial / NCT05763576
A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection
RandomizedSequentialDouble-blindTreatment
Summary
This is a first in human (FIH), multi-center, dose-finding, and dose-escalation Phase I clinical study of RO7565020 to investigate the safety and tolerability and to characterize the pharmacokinetics and pharmacodynamics following single and/or multiple doses of RO7565020 in healthy participants and/or virologically suppressed participants with chronic hepatitis B (CHB).
Timeline
- Start
- 2023-04-28
- Primary completion
- 2024-12-23
- Completion
- 2024-12-23
Outcome
Outcome not reported
Stopped: “The Sponsor decided to discontinue the development of RO7565020 and as a result the BP44118 study was terminated.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RO7565020 | Unknown | — | Subcutaneous |
| Background | Entecavir | Small molecule | — | Oral |
| Background | Tenofovir disoproxil fumarate | Small molecule | — | Oral |
| Background | tenofovir alafenamide | Small molecule | — | Oral |