For Sponsors, initiating a Phase I trial can represent both an important milestone and anxious time. While traditional Phase I trials are the first time a New Molecular Entity (NME) is studied in human subjects, and typically include single and multiple ascending dose cohorts characterizing the early safety and tolerability profile, it is critical that the Phase I study plan also be rigorously conducted to collect pharmacokinetic (PK) and pharmacodynamic (PD) data to better inform subsequent later phase trials.
Apex has significant expertise in designing and conducting a broad range of Phase I trials in healthy volunteers. In addition to trials in healthy normal volunteers (HNVs), we have vast experience conducting trials in “special populations” including healthy elderly volunteers (HNEs) and Japanese and Chinese populations. We have conducted trials evaluating the safety/tolerability, PK, and PD of an array of drugs and biologics with a wide variety of routes of administration.
At Apex, we excel at these Phase I studies and more:
- First-in-Human (FIH)
- Single Ascending Dose (SAD)
- Multiple Ascending Dose (MAD)
- Drug-Drug Interaction (DDI)
- Bioavailability (BA)
- Bioequivalence (BE)
- Food Effect (FE)
- Thorough QT (TQT)
- Adaptive protocol designs that include nested SAD/MAD cohorts in addition to FE and DDI cohorts
Phase I Inpatient Units
Our state-of-the-art clinical research facilities were specially designed for early phase research and include dedicated areas for healthy subjects. All have secure medication dispensaries, CLIA Waived labs, PK drawing rooms, and facilities for other specialized safety (e.g., telemetry) and pharmacodynamic (e.g., electrophysiology, cognitive testing) procedures.
Collaborative Neuroscience Research
Long Beach, CA (76 beds)
Hassman Research Institute
Marlton, NJ (60 beds); Berlin, NJ (28 beds)
Consistently meeting and exceeding enrollment goals
CNS and HRI’s outreach databases each have approximately 15,000 healthy individuals.
Apex offers flexible solutions across its sites to support Sponsor’s timelines and efficiency.
CNS and HRI have supported many Phase I trials by providing an efficient and synergistic two-site solution, accelerating sponsors’ drug development programs. The seamless execution of trials with the enrollment benefits of multiple sites is made possible by standardized early phase procedures, technology processes, and training/quality control processes across sites.
We develop and support successful strategies requiring specialized technologies and scientific and regulatory guidance
Sponsors look to us to partner in program development and to incorporate novel biomarker strategies into their protocols. We have exceptional experience in designing strategies that efficiently de-risk proof-of-concept Phase II trials and providing results that increase the confidence of go/no-go decisions.
First-In-Human Risk Mitigation
Apex is committed to keeping up to date with the latest design and conduct considerations for FIH trials and continuously developing and perfecting our own guidelines to ensure efficient and successful FIH trials. With great care and thoroughness, our experts developed the “Phase I, FIH Medical Risk Identification Process” which includes a methodical assessment of key risks and details measures to address them from a clinical pharmacology and medical safety perspective. This process, which we utilize with all FIH trials, includes but is not limited to:
- Collaborative Sponsor/Apex/CRO discussions around increasing the safety of study participants
- Review of initial maximum recommended starting dose (MRSD) estimate and dose escalation scheme as appropriate by clinical pharmacologist(s) and Principal Investigator(s)
- Risk assessment and mitigation strategy for dosing
- Participation in dose escalation meetings and post-conduct lessons learned meetings