Phase I Early Clinical Development
Seamless Phase I Programs for Market Success
First-in-human studies are demanding and multidimensional, requiring a finely tuned balance between scientific rigor, patient safety, regulatory requirements and market access strategies.
Orchestrating these disparate elements requires an experienced and dedicated team of experts who collaborate to inform, advise and execute your Phase I studies. PPD’s dedicated Phase I professionals customize solutions to fit your unique compound, business model and study objectives.
FOCUS ON COMPLEX STUDY DESIGN
At PPD, we understand that early phase development in complex studies requires a highly coordinated effort to anticipate challenges, recruit the right subjects, engage experienced investigators and design a trial that will establish a platform for later-stage clinical success.
PPD’s early development team performs complex studies through our global network of sites. With over three decades of experience conducting Phase 1 trials, our teams bring a unique understanding on how high-quality performance looks and we work with our sites to ensure conduct and data meets an exacting standard.
IN-DEPTH Phase I SCIENTIFIC AND THERAPEUTIC EXPERTISE
COVERING YOUR PHASE I NEEDS
- Single ascending dose (SAD)/multiple ascending dose (MAD)
- Drug-drug interaction
- Bioequivalence/bioavailability
- ADME
- Renal/hepatic
- Pharmacokinetics (PK)
- Pharmacodynamics (PD)
- Cardiac intensive studies
- Food effect
- Dedicated cardiac safety (thorough QTc)
- Glucose clamp studies
- Ethnobridging studies
- First-in-human (FIH)
- Dose selection/optimization
- Proof-of-concept
- Disease modeling
- Medical imaging capabilities
ACROSS A SPECTRUM OF THERAPEUTIC SPECIALTIES
- Cardiovascular
- Cell and gene therapy
- Critical care
- Dermatology
- Gastroenterology
- Immunology and rheumatology
- Infectious diseases
- Metabolic and endocrine
- Nephrology and renal disease
- Neuroscience
- Oncology/hematology
- Ophthalmology
- Pediatrics
- Rare diseases
- Respiratory
- Urology
- Vaccine development
- Women’s health
FLEXIBLE SOLUTIONS CUSTOMIZED TO FIT YOUR Phase I STUDY NEEDS
PPD provides comprehensive and flexible pharmacokinetic (PK) and pharmacodynamic (PD) support of Phase I-IV clinical trials. We offer clinical pharmacology expertise as part of an integrated drug development program or as a discrete stand-alone service with clinical, scientific and regulatory experience in a variety of areas.
- Translational Medicine including toxicokinetics (TK)
- Clinical pharmacology program and protocol development and support
- Analysis and interpretation of PK and PK/PD data
- Scientific and medical expertise aligned to each client’s pipeline
- Comprehensive access to patients, healthy volunteers and special populations
- Experience in design and execution of both adaptive and traditional early phase studies
- A fit-for-purpose, flexible operating model
Seeking Ways to Ensure Participant Safety in First-in human Trials
Kirsten Messmer, Ph.D., R.A.C., principal regulatory affairs specialist, details changes in regulatory guidelines for first-in-human trials.