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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05614895

Enrollment

Registered

2022-11-14

Start date

2022-12-03

Completion date

2024-01-13

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Infections

Brief 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.

Interventions

DRUGRO7223280

Participants will receive RO7223280, 600 mg, IV infusion for 1 hour on Day 1.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Illness requiring treatment in an intensive care unit (ICU) at the time of enrolment * Ongoing clinical syndrome meeting at least one of the following criteria: 1. HABP: bacterial pneumonia diagnosed after more than 48 hours of hospitalization or within 7 days after a hospital discharge 2. Ventilator-associated bacterial pneumonia (VABP): bacterial pneumonia diagnosed after more than 48 hours of mechanical ventilation or within 72 hours after weaning 3. Bacteremia confirmed by the presence of a bacterial pathogen in a blood culture drawn within 7 days prior to dosing and with the defined focus of infection. 4. For Cohort 4 only: mechanically ventilated participants who have a BAL procedure planned as part of routine practice for a day that can function as Day 1.

Exclusion criteria

* Ongoing documented catheter-related bacteraemia as the sole ongoing infection * Major surgery within 48 hours prior to dosing or major surgery expected within 48 hours after the start of the infusion * Known chronic severe hepatic impairment (Child-Pugh class C). Note: acute severe hepatic impairment is not exclusionary

Design outcomes

Primary

Measure	Time frame
Plasma Concentrations of RO7223280	Cohort 1-3: From Day 1 up to Day 3; Cohort 4: From Day 1 up to Day 5

Secondary

Measure	Time frame
Percentage of Participants With Adverse Events (AEs)	Cohort 1-3: From Day 1 up to Day 4; Cohort 4: From Day 1 up to Day 5
Percentage of Participants With Serious Adverse Events (SAEs)	Cohort 1-3: From Day 1 up to Day 4; Cohort 4: From Day 1 up to Day 5
Percentage of Participants Who Died Due to Any Cause	Cohort 1-3: From Day 1 up to Day 4; Cohort 4: From Day 1 up to Day 5

Countries

France, Israel, Moldova, South Korea, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026