Placebo-controlled First-in-Human Study of Oral TQS-168 in Healthy Volunteers

This first-in-human study provided data on safety, tolerability, and PK data for TQS-168 and also successfully evaluated three different formulations and selected a lead spray-dried dispersion (SDD) formulation for future patient studies.

TQS-168, a first-in-class small-molecule inducer of peroxisome proliferator-activated receptor gamma coactivator 1-alpha gene expression, is in development for the treatment of amyotrophic lateral sclerosis.

A single-ascending-dose (SAD) and multiple-ascending-dose (MAD) study of TQS-168 was carried out in healthy male subjects to investigate safety, tolerability, pharmacokinetics (PK), food effect, and preliminary pharmacodynamic effects (PD). 

This study demonstrated that TQS-168, a novel PGC-1α enhancer, is well tolerated in humans at oral doses that produce plasma exposures in the therapeutic range.

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