Phase 1/First in Human Studies
- 17,000+ Healthy Normal Volunteers in CTMS managed database
- In-house recruitment team supported by mobile recruitment unit
- Data-driven outreach targeting new and prescreened participants based on health profiles, demographic selectors, and I/E criteria
- Consistent Community Outreach through regular medical volunteering at regional health fairs and the Community Clinic of High Point
FIH STUDY EXPERIENCE
SAD/MAD and Adaptive designs
Safety and Tolerability
PK/PD
Food Effect and POC arms
Wide range of ROA capabilities
EXPERIENCE & ABILITIES
- Purpose-built and adaptive Patient-centric facility with 24/7 medical oversight of short and long-term confinement studies
- Executive Leadership team with significant clinical pharmacology and drug development experience
- Full-time, board-certified emergency medicine physicians
- Pharmacy staff experienced in the preparation and dispensing of multiple IP formulations
Certifications
- ACLS Certified nursing and medical staff
- DEA license for Schedule II-IV drugs
- ISO Class 5 fume hood
- Licensed clinical research pharmacy
Specialized Assessments and Partners
- Cardiac safety
- Cognitive assessments
- CSF Collection (serial or lumbar puncture)
- Dietary Control
- EEG monitoring and recording
- Eye examinations
- Gastroenterology and Nephrology partners
- In-house Fibroscan
- PET + CT Scans/MRI/X-ray and Ultrasounds
- Pulmonary Function Testing (Spirometry/FVC)
FIH ADAPTIVE INTEGRATED DESIGNS
Integrated adaptive designs generate cost and time efficiencies while maximizing the amount of data collected early in the development pathway making the IMP more attractive to investors. Study design is typically influenced by IMP profile, ROA and targeted indication.
This FIH study was designed to evaluate safety, tolerability, PK/PD, food effect (FE) as well as POC. Optional cohorts were built into the protocol along with cardiac safety assessments to potentially obtain a TQT exemption.
