Phase I Services

Clinilabs provides full Phase I capability, with experience in a variety of early phase studies that are required for regulatory approval.  We offer high quality testing on all Phase I projects.

  • First in human 
  • Dose ranging, single ascending dose (SAD)
  • Dose ranging, multiple ascending dose (MAD)
  • Bioavailability (BA)
  • Bioequivalence (BE)
  • Pharmacokinetic (PK)
  • Pharmacodynamic (PD)
  • Drug and food interaction
  • Blind dosing/sampling
  • Phase I highlights
    •  Sleep and wakefulness in an accredited sleep facility (PSG, MSLT, MWT)
    • Cognitive assessment by licensed psychologists (computerized batteries)
    • Metabolic assessment (calorimetry, hormone analyses)
    • Reproductive safety (sperm count, motility, morphology)
    • EEG, EMG, evoked potentials
    • Cardiorespiratory assessments
    • TQT and intensive ECG
    • Biomarker studies, including CSF and cCSF sampling, imaging