Safety and Toxicology

BIO 300 - Preclinical Safety and Toxicology

BIO 300 has a robust multi-species safety and toxicology database, which has enabled Humanetics to open three active Investigational New Drug applications and proceed to human trials.

Data has been collected across multiple administration routes including oral (PO), intramuscular (IM) and intravenous (IV).  Absorption, distribution, metabolism and excretion studies have been performed in multiple species.


Human safety has been evaluated in healthy volunteers in two completed phase 1 studies: a safety and pharmacokinetic study of BIO 300 Capsules (NCT00504335) and BIO 300 Oral Powder (NCT04650555). Additional safety has been assessed in patients with non-small cell lung cancer (NSCLC; NCT02567799).