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Pagibaximab · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| 10 mg/kg | EXPERIMENTAL | 10 mg/kg was given on Days 0, 14 |
| 30 mg/kg | EXPERIMENTAL | 30 mg/kg was given on Days 0, 14 |
| 60 mg/kg | EXPERIMENTAL | 60 mg/kg was given on Days 0, 14 |
| 90 mg/kg | EXPERIMENTAL | 90 mg/kg was given on Days 0, 14 |
| Name | Type | Description |
|---|---|---|
| Pagibaximab (formerly BSYX-A110) | DRUG | Pagibaximab at 10, 30, 60, 90 mg/kg intravenously at Days 0 and 14. |
Inclusion Criteria: Patients must meet all of the following criteria at the time of first infusion (Day 0): 1. 3-7 days of age, inclusive 2. Birth weight of 700-1300 grams 3. Survival expected for at least 1 week after infusion 4. Inpatient in a Neonatal Intensive Care Unit with intravenous access...
Pagibaximab is an investigational small molecule being developed for the prevention of neonatal Staphylococcal sepsis, a serious bloodstream infection in newborns. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
Pagibaximab is designed to target staphylococcal bacteria, which are the cause of Staphylococcal sepsis in neonates. The drug aims to prevent or treat this infection in vulnerable newborns, though its specific molecular target has not been disclosed.
Pagibaximab is being developed by GSK plc, a global biopharmaceutical company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in neonatal patients.
Pagibaximab is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by the FDA or other regulatory bodies. The drug is still undergoing early-stage trials to assess its safety and how it is processed by the body.
Pagibaximab has one completed Phase 1 clinical trial, registered as NCT00631878. This study, titled 'Safety and Pharmacokinetics Study in VLBW Neonates With BSYX-A110,' enrolled 53 participants in the United States. The trial was randomized, double-blind, and placebo-controlled, involving neonates as young as 3 days old.
Yes, Pagibaximab is also known as BSYX-A110. The clinical trial NCT00631878 uses the name BSYX-A110 in its title, confirming that these names refer to the same investigational drug being developed by GSK for neonatal Staphylococcal sepsis.