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NCT04605718 · ClinicalTrials.gov registry record · Phase 1
A Study To Investigate The Safety, Tolerability And Pharmacokinetics (PK) Of RO7223280 Following Intravenous Administration In Healthy Participants
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 124
- Enrollment target
NCT04605718: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT04605718 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 124 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (107% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04605718, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 124 participants
- Enrollment target
Study Summary
The Study consists of 3 Parts: Part 1 (Single Ascending Dose/SAD), Part 2 (Multiple Ascending Dose/MAD), and Part 3 (Elderly). Part 1 will investigate the safety, tolerability and PK of single-ascending intravenous (IV) doses of RO7223280 in healthy participants. Part 2 will investigate the safety, tolerability and PK of multiple-ascending IV doses of RO7223280 in healthy participants. Part 2 will start after the initial completion of Part 1 (SAD). Progression from Part 1 to Part 2 will be based on a satisfactory review of all available safety, tolerability, and PK data by the Investigator and the Sponsor from Part 1. The starting dose for Part 2 will be administered as 1-hour IV infusion; as it has been established on the basis of all available safety, tolerability, and PK data in Part 1 (SAD). Part 3 will investigate the safety, tolerability and PK of a single IV dose of RO7223280 in healthy elderly participants. A single IV dose of RO7223280 administered over 1 hour was selected, within the range of previously explored doses in Part 1 (SAD).
Interventions
- DRUG RO7223280
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2020-12-07 |
| Est. Completion | 2023-03-09 |
| Phase | Phase 1 |
What the finished NCT04605718 record still lists
NCT04605718 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (107% higher).
The record links to 0 conditions, and to 1 intervention - of which RO7223280 is the first listed.
NCT04605718 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04605718 about?
NCT04605718 is a clinical study titled "A Study To Investigate The Safety, Tolerability And Pharmacokinetics (PK) Of RO7223280 Following Intravenous Administration In Healthy Participants". The Study consists of 3 Parts: Part 1 (Single Ascending Dose/SAD), Part 2 (Multiple Ascending Dose/MAD), and Part 3 (Elderly). Part 1 will investigate the safety, tolerability and PK of single-ascending intravenous (IV) doses of RO7223280 in healthy participants. Part 2 will investigate the safety, ...
What is the current status of trial NCT04605718?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 124 participants. The study started on 2020-12-07. Estimated completion is 2023-03-09.
What interventions are being tested in trial NCT04605718?
The interventions under investigation include: RO7223280 (DRUG).
Who is sponsoring clinical trial NCT04605718?
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 NCT04605718's enrollment target sits among peer trials
124 471st of 2000 higher than 1,526 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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