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First-in-Human (FIH)

First-in-Human (FIH)

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With unrivaled expertise and experiences in end-to-end drug development programs, CD BioSciences offers integrated solutions for the entire program from bioanalytical lab testing, first-in-human (FIH), proof of concept (POC), clinical trial development, to data management. You can partner with us for the entire program or just one module. We offer you complete flexibility.

First-in-Human (FIH) Studies

FIH is a critical milestone in the entire drug development program. With extensive experiences in the design and conduction of FIH studies, our experts are dedicated to closely working with you to meet your objectives and milestones for small molecule or biologics drugs. We offer FIH studies to facilitate your drug development including study design, study conduction, analyzing and reporting. Moreover, we offer the regulatory support in U.S. and several other countries. We can translate your preclinical data into clinical trial design and conduction. The most important is we consider the participant safety in priority with stringent risk mitigation plans, which is customized based on the specific drug target and available preclinical data.

Our Experts

To serve your entire FIH study, our experts have rich expertise across different disciplines including clinical pharmacologist, safety physician, formulation scientist, clinical development scientist, clinical operation specialist, toxicologist, regulatory affair specialist etc. Our clinical pharmacologists are experienced in single and multiple dose studies for various effects analysis, such as age, gender, food and others. Our toxicologists are dedicated to providing support for starting dose calculation. In addition, they closely work with our clinicians in determining best clinical study monitoring approaches to observe the effects, based on the preclinical data.

Safety is Our Priority

Our clinical team is committed to ensuring the participants safety before initiating each FIH study. We offer stringent participant oversight to ensure safety conduction of various ascending dose studies.

Our Highlights

Empowered by our extensive 10+ years of experience conducting early clinical trials in state-of-the-art facilities, our clinical team is dedicated to meeting your specific requirements of early clinical trials for regulatory submission purpose.


Therapeutic Areas

We offer FIH studies across a wide range of therapeutic areas, for different drug types including small molecules, cellular therapies, therapeutic antibodies etc. If you have FIH study requirements for your drug development program, please don’t hesitate to reach out to our clinical team for assistance.


With extensive experience in recruiting healthy participants, patients or special populations, CD BioSciences is able to quickly fill the cohorts and conduct FIH studies as per your specific requirements. We are dedicated to being a full-service CRO focused on the early clinical trial development programs. Please contact us to learn how we can help with your upcoming FIH study.

1. Shen, Jie, et al. "Design and Conduct Considerations for First-in-Human Trials." Clinical and Translational Science 12.1 (2019): 6-19.

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