A First-in-Human Assessment for TQS-168, Including Safety, Tolerability, Pharmacokinetics, Formulation Selection, and Food effect in healthy volunteers
8 October 2025TQS-168, a first-in-class peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC1α) inducer in development for the treatment of amyotrophic lateral sclerosis (ALS) and Parkinson’s disease.
TQS-168 is a Biopharmaceutics Classification System (BCS) Class II compound, and preclinical data have indicated solubility limited absorption, hence solubility enhancement is likely required to achieve adequate exposure in humans.
The purpose of the first in human (FIH) study was to establish safety, tolerability and pharmacokinetics (PK) for TQS-168, but also to assess performance of solubility enhanced formulations, allowing selection of an appropriate technology for Phase II progression. The food effect was also assessed on the selected formulation technology.
