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RO7223280

Phase 1

Bacterial Infections | Small molecule | Infectious Disease |Roche Holding AG|Trials Updated: Jan 22, 2024

RO7223280 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Oct 2020

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

RO7223280 clinical trials

RO7223280 · 1 trial · 1 indication

Phase 1 1
NCT05614895A Study to Investigate the Pharmacokinetics of RO7223280 in Critically Ill Participants With Bacterial InfectionsBacterial Infections
COMPLETED48 Analytics
PHASE1COMPLETED
A Study to Investigate the Pharmacokinetics of RO7223280 in Critically Ill Participants With Bacterial Infections
Bacterial InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

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
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALBacteremia participants without pneumonia and who are not mechanically ventilated at screening will be enrolled in this cohort. Participants will receive RO7223280 on Day 1.
Cohort 2EXPERIMENTALParticipants with hospital-acquired bacterial pneumonia (HABP) and who are not mechanically ventilated at screening will be enrolled in this cohort. Participants will receive RO7223280 on Day 1.
Cohort 3EXPERIMENTALParticipants with mechanical ventilation at screening will be enrolled in this cohort. Participants will receive RO7223280 on Day 1.
Cohort 4EXPERIMENTALParticipants with mechanical ventilation who have a bronchoalveolar lavage (BAL) planned as a part of routine practice will be enrolled in this cohort. Participants will receive RO7223280 on Day 1.

Interventions

NameTypeDescription
RO7223280DRUGParticipants will receive RO7223280, 600 mg, IV infusion for 1 hour on Day 1.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites16

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 hospi...

Countries:United StatesFranceIsraelMoldovaSouth Korea
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Frequently asked questions about RO7223280

What is RO7223280?

RO7223280 is an investigational small molecule developed by Roche Holding AG for the treatment of bacterial infections. It is in Phase 1 clinical development and has been studied in critically ill patients. It is not yet approved for any indication.

What is RO7223280 used for?

RO7223280 is being developed for bacterial infections. Its only completed clinical trial enrolled critically ill participants with bacterial infections to investigate the drug's pharmacokinetics. It remains investigational and is not approved for clinical use.

Who makes RO7223280?

RO7223280 is developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche is the sponsor of the clinical program evaluating this small molecule for bacterial infections.

What phase is RO7223280 in?

RO7223280 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not received FDA approval.

What clinical trials is RO7223280 in?

RO7223280 has been evaluated in one completed Phase 1 trial, NCT05614895, titled A Study to Investigate the Pharmacokinetics of RO7223280 in Critically Ill Participants With Bacterial Infections. The trial enrolled 48 participants across the United States, France, Israel, Moldova, and South Korea.