Overview:
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 hosted by ASCPT 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 FIH studies
- Strategic approach for FIH 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
Speakers:
Jocelyn Courville
Jocelyn is a Senior Director of Clinical Pharmacology at ICON. Before joining ICON, she served as a global clinpharm program lead at several major pharma companies, where she supervised a range of drug programs. Jocelyn skilfully offers guidance to customers on optimal trial design, dose selection, PK/PD assessment, and other intricate clinical pharmacology related data analysis and execution strategies.
Ad Roffel
Ad is a Senior Director of Clinical Pharmacology at ICON. He is involved in advising and supporting our customers with respect to drug development, including the design of studies, PK and PD parameters, inclusion/exclusion criteria, and ethics. Focus areas have been thorough QT studies, respiratory medicine, and 14C microdosing and AME 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 utilised 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.