FIRST-IN-HUMAN CLINICAL TRIALS (FIH)
We have decades of first-in-human clinical 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 clinical 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 Solution E-Book.
- Healthy Participants
- Special Populations (age, BMI, or gender specific)
- Patient Populations
COMPLETED FIH STUDIES
First In Human Trials (FIH) - FAQs
What are first in human (FIH) trials?
The U.S. Food and Drug Administration (FDA) Phase I trial includes the first human exposure to an investigational drug (IND). Phase I or FIH trials are typically not large, usually involving from 20-80 subjects. The objective of a classical first in human trial is to determine the safe dose range for further clinical development.
What data are required to support the start of first in human trials?
Prior to starting first in human trials, you will be required to submit preclinical and other safety data to the local regulatory authorities to evaluate, to ensure that your drug product is safe for human testing. In the U.S., the Food and Drug Administration (FDA) is responsible for managing drug approvals, and in Europe the European Medicines Agency (EMA) is the regulating body.
Are there any complementary trials I may need to consider when planning my FIH trial(s)?
You may want to conduct an early QT study, in order to avoid the need for a more detailed thorough QT trial later in development. Depending on your intended indication and signals from safety data, you may also want to consider studying use in special populations or renal/hepatically impaired individuals, and you may need human abuse potential or cognitive/driving impact assessments.
Can Altasciences manufacture the product I need for my first in human trials?
Our manufacturing and analytical services can provide you with clinical trial materials developed under cGMP conditions, for your preclinical and clinical. First in human trials require clinical grade material, and we have the certified facilities to produce liquid and powder-filled capsules, creams, gels, and a range of other products.
Are you able to recruit the target populations needed for any FIH trial?
Altasciences has a database of 345,000 participants, with full medical screening profiles to allow for targeted outreach and recruitment efforts. We also have collaborative arrangements with local clinics and hospitals for studies involving patients.
Our deep expertise and capabilities in a broad range of therapeutic areas encompasses preclinical and early clinical studies for both small molecules and biologics. We can manage your entire program, as well as provide comprehensive support research services and bioanalytical expertise.