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NCT05763576 · ClinicalTrials.gov registry record · Phase 1
A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT05763576: Clinical Trial Phase 1 study, sponsored by Hoffmann-La Roche.
NCT05763576 is a Phase 1 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05763576, a Phase 1 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study 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).
Primary Outcome
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory finding), symptoms, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any significant hazard, contraindication, or side effect that is fatal
Interventions
- OTHER Placebo
- DRUG RO7565020
- DRUG Nucleos(t)ide analogue (NUC) treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-04-28 |
| Est. Completion | 2024-12-23 |
| Phase | Phase 1 |
Why NCT05763576 stopped before completion
NCT05763576 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05763576 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05763576 about?
NCT05763576 is a clinical study titled "A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection". 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...
What is the current status of trial NCT05763576?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2023-04-28. Estimated completion is 2024-12-23.
What interventions are being tested in trial NCT05763576?
The interventions under investigation include: Placebo (OTHER), RO7565020 (DRUG), Nucleos(t)ide analogue (NUC) treatment (DRUG).
Who is sponsoring clinical trial NCT05763576?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05763576's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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