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nacubactam · 1 trial · 1 indication
The ELF to plasma ratio will be calculated from the concentration of nacubactam in ELF and plasma as a measure of the intrapulmonary penetration of nacubactam in healthy participants.
| Arm | Type | Description |
|---|---|---|
| Nacubactam Plus Meropenem | EXPERIMENTAL | Participants will receive a single dose of nacubactam co-administered with meropenem. |
| Name | Type | Description |
|---|---|---|
| nacubactam | DRUG | Participants will receive a single 2000 milligram (mg) intravenous (IV) infusion of nacubactam over 1.5 hours. |
| meropenem | DRUG | Participants will receive a single 2000 mg IV infusion of meropenem over 1.5 hours. |
Inclusion Criteria: * 18 to 60 years of age, inclusive * Healthy, as judged by the Investigator and defined by the absence of evidence of any active or clinically significant chronic disease identified from a detailed medical and surgical history, physical examination including vital signs and 12-l...
Nacubactam is an investigational small molecule being developed for Gram-negative bacterial infections. It is currently in Phase 1 clinical development and is not approved by the FDA. The drug is being studied for its ability to treat infections caused by Gram-negative bacteria.
Nacubactam is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in healthy volunteers.
Nacubactam is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug remains in early-stage clinical testing.
Nacubactam has one completed Phase 1 trial, NCT03182504, which investigated the intrapulmonary lung penetration of the drug in healthy participants. The study enrolled 21 participants in the United States and was an uncontrolled, open-label trial.
No, nacubactam is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial focused on lung penetration in healthy volunteers, and further studies would be needed to establish safety and efficacy.