The third panel of the Phase Ib trial has started, aiming at evaluating the safety and tolerability of PBTZ169 at a dose of 600 mg, once a day for 14 days, in healthy volunteers.
The third panel of the Phase Ib trial has started, aiming at evaluating the safety and tolerability of PBTZ169 at a dose of 600 mg, once a day for 14 days, in healthy volunteers.
Our colleagues from the Laboratory & Service of Clinical Pharmacology at the CHUV validated an innovative methodology using multiplex UHPLC-MS/MS for the analysis and quantification of PBTZ169, as well as five of its metabolites, in the plasma of the healthy volunteers who participated in the phase Ia clinical study.
Read MoreThe Trial Safety Board assessed the safety and tolerability parameters for panels A and B, and authorized dose escalation as no salient adverse events were observed with PBTZ169 300 mg administered b.i.d. for 2 weeks. The trial will continue with panel C (600 mg q.d.) scheduled for June 2019.
The phase Ib clinical trial with PBTZ169 (multiple ascending doses) officially started, dose escalation will be performed through four panels A, B, C and D.
To evaluate the efficacy of PBTZ169 in combination with a range of other anti-tuberculosis (TB) drugs, our collaborators from the Cole lab, at the Global Health Institute of the EPFL, used in vitroassays and mouse models in order to design a new regimen against active TB. Notably, synergism could be observed when PBTZ169 was applied in combination with bedaquiline, clofazimine, delamanid and sutezolid.
Read MorePBTZ169 has been named Macozinone. Read more here.
The phase Ia clinical trial with PBTZ169 is completed and the collected safety data, as well as pharmacokinetic and pharmacodynamic parameters, are being analyzed.
The first three investigation panels of the Phase Ia clinical trial have been successfully completed. The fourth and final panel has started and healthy male volunteer recruitment is complete.
2017 has been an exciting year during which the iM4TB Foundation made many accomplishments. Pre-clinical trials were successfully completed with PBTZ169 continuing to show all its earlier promise at being a new cure for tuberculosis. Phase Ia of clinical trials was approved by Swissmedic and are moving ahead at the CHUV; this was largely made possible by a very generous donation from the Bill and Melinda Gates Foundation.
Read MoreThis is a randomized, double-blind, placebo-controlled, single ascending dose study conducted at one study center in Switzerland.
Four panels (A, B, C and D) of 8 male subjects (6 active and 2 placebo) each undergoing two investigation periods and receiving either single doses of PBTZ169 at increasing dose levels or a matching placebo. Subjects will participate in only one panel. Blocks of 4 subjects (3 under active treatment, 1 under placebo) will be investigated in parallel. Panels A and B are interleaved.
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