First-In-Human Trials (FIH)

We have decades of first in human trial experience, designing, conducting, analyzing, and reporting on FIH studies for small molecules and biologics, and we offer the opportunity to begin the regulatory process in either the U.S. or Canada. Our clinical pharmacologists are proficient at designing NDA-enabling studies, including single and multiple ascending dose studies, as well as testing for various effects, such as age, gender, and food. Our first in human trials routinely include assessments of biomarkers or symptom assessments to establish proof of concept. Our toxicologists provide support in calculating starting doses, and work with our clinicians in determining the best Phase I clinical trial monitoring practices for effects observed during preclinical trials.

Our clinics have purpose-built units that offer the stringent patient oversight required to safely perform ascending dose studies required. Before starting each FIH study, our clinical teams perform a risk assessment to ensure we are appropriately staffed and resourced to ensure participant safety for your critical FIH trials.

We have the recruiting experience and capacity to quickly fill FIH study cohorts that are dosed weekly, and can add patient cohorts or conduct entire studies in patients, as needed.

Consult our FIH Fact Sheet.