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 two 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.
BIO 300 - CLINICAL SAFETY
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).