FDA Authorizes Study Protocol for New Mode of Administration for Trogarzo
US Food and Drug Administration （FDA）has authorized TMB-302, the study protocol to evaluate an intravenous (IV) slow push formulation of Trogarzo (ibalizumab-uiyk) injection.
TMB-302 will evaluate the safety and pharmacokinetics of administering undiluted Trogarzo during the maintenance phase at 800 mg once every two weeks as an intravenous (IV) push over 30 seconds. The study will enroll 20 patients and will be conducted over a 12-week period. Patients will be followed for up to 28 days following the study completion.