Trials / Completed
CompletedNCT05614895
A Study to Investigate the Pharmacokinetics of RO7223280 in Critically Ill Participants With Bacterial Infections
A Multicenter, Single-Dose, Uncontrolled, Open-label, One Group Study to Investigate the Pharmacokinetics of RO7223280 in Critically Ill Patients With Bacterial Infections
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The main aim of the study is to investigate the plasma pharmacokinetics (PK) and safety of intravenous (IV) administration of a single dose of 400 milligrams (mg) or 600 mg RO7223280 in critically ill participants with bacterial infections.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RO7223280 | Participants will receive RO7223280, 600 mg, IV infusion for 1 hour on Day 1. |
| DRUG | RO7223280 | Participants will receive RO7223280, 400 mg, IV infusion for 1 hour on Day 1. |
Timeline
- Start date
- 2022-12-03
- Primary completion
- 2024-01-13
- Completion
- 2024-01-13
- First posted
- 2022-11-14
- Last updated
- 2024-01-22
Locations
16 sites across 5 countries: United States, France, Israel, Moldova, South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05614895. Inclusion in this directory is not an endorsement.