Strategic Approaches for FIH Studies and Early Clinical Development

May 29, 2024

Panelists: Jocelyn Courville, PhD, and Ad Roffel, PhD

Description & Registration

ASCPT Partner Event Presented by ICON*

The transition from preclinical experiments to first in human clinical trials signifies a significant milestone in the development of any new drug candidate. The first-in- human (FIH) study evaluates an investigational medicinal product (IMP) in humans for the first time, focusing on assessing its safety, tolerability, and human pharmacology (PK/PD) of the molecule. Typically, a FIH study involves single ascending dose and multiple ascending doses to establish the appropriate dosing range for further development. A thorough understanding of the molecule’s characteristics and behavior in humans, including dose-response relationship, safety signals, and key PKPD parameters, facilitated by the right study design and accurate execution, is crucial for informed decision-making.

Following the FIH study, depending on existing knowledge about your asset, you may be confronted with the need to run an absorption, metabolism and excretion (AME) study in order to de-risk liabilities resulting from drug metabolism or elimination. This requires timely preparations, and choices to be made.

During this webinar we will discuss the following topics:

1.) Cohort planning and dose selection in first-in-human (FIH) studies.

- Discussion on main objectives and essential components of FIT studies.

- Strategic approach for FIT study design and recommended methods for dose selection.

2.) Options for running a hAME study.

- The various approaches to running a hAME study including: AME or ABA as part of the first FIH study, microtracer or "high dose AME", and the differences in the conduct of hAME studies across geographic regions.

3.) Progression into early patient studies.

- Insights into the considerations involved in selecting the appropriate population for early clinical development and transitioning into patient studies.

Target Audience:

This webinar is crafted to assist individuals engaged in early clinical development in further grasping the complexities of risk management and mitigation requirements, as well as the rationale behind starting dose selection and dose escalation approaches utilized in first in human studies and similar aspects of early hAME studies. The multifaceted nature of FIH studies not only presents challenges but also opportunities to facilitate efficient and safe progression from early phase to later phase studies, encompassing various aspects of research within clinical pharmacology, translational science, medical expertise, PK and PD analysis, and clinical operation. AME studies in humans, while much smaller than FIH studies, also come with multiple unique aspects and require timely preparations in fields as diverse as radiosynthesis, dosimetry, regulatory submission, clinical conduct, bioanalysis, and analysis and reporting. Participants from these diverse fields can all derive valuable insights from this webinar.

*This message and event is sponsored by an ASCPT Partner organization. The content of the message is provided for informational purposes only and does not constitute or imply ASCPT's endorsement, recommendation, or approval of a specific institution, service, employer, or content.