Approval Probability
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Adjusted LOA
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RO7223280 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Bacteremia 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 2 | EXPERIMENTAL | Participants 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 3 | EXPERIMENTAL | Participants with mechanical ventilation at screening will be enrolled in this cohort. Participants will receive RO7223280 on Day 1. |
| Cohort 4 | EXPERIMENTAL | Participants 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. |
| Part 1 (SAD) | EXPERIMENTAL | Due to mandatory sentinel dosing, participants will be divided into two groups: 2 participants will be dosed on one day (sentinel group with 1 on active treatment and 1 on placebo) and remaining participants of the dose cohort (randomized as 5 on active treatment and 1 on placebo) at the earliest 24 hours after the first dosing occasion. |
| Part 2 (MAD) | EXPERIMENTAL | In each dose cohort, a minimum of 4 participants and a maximum of 12 participants will receive either multiple IV doses of RO72232809 or placebo once-daily for 10 days (3:1 ratio of active:placebo treatment). |
| Part 3 (Elderly) | EXPERIMENTAL | In this cohort, a minimum of 4 participants and a maximum of 12 participants will receive a single IV dose of RO7223280 or placebo (3:1 ratio of active:placebo treatment). |
| Name | Type | Description |
|---|---|---|
| RO7223280 | DRUG | Participants will receive RO7223280, 600 mg, IV infusion for 1 hour on Day 1. |
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...
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RO7223280 is an investigational small molecule being studied for use in healthy volunteers and in critically ill participants with bacterial infections. It is administered intravenously. The drug is being developed by Roche Holding AG and is currently in Phase 1 clinical development.
The molecular target of RO7223280 has not been disclosed in available clinical trial information. The drug is being studied for its safety, tolerability, and pharmacokinetics in healthy participants, and for its pharmacokinetics in critically ill patients with bacterial infections.
RO7223280 is being developed by Roche Holding AG, a multinational healthcare company. Roche is conducting clinical trials to evaluate the drug's safety, tolerability, and pharmacokinetics in healthy volunteers and in patients with bacterial infections.
RO7223280 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one in healthy volunteers and one in critically ill participants with bacterial infections. The drug is investigational and has not been approved by regulatory authorities.
RO7223280 has been studied in two completed Phase 1 trials. NCT04605718 evaluated safety, tolerability, and pharmacokinetics in healthy participants in the United States. NCT05614895 investigated pharmacokinetics in critically ill participants with bacterial infections across the United States, France, Israel, Moldova, and South Korea.
No alternative names for RO7223280 have been disclosed in available clinical trial information. The drug is identified solely by its code name RO7223280 in the trials registered on ClinicalTrials.gov.