Phase 1 Clinical Trials2021-12-13T20:48:46+00:00

Phase 1 Clinical Trials

Early-phase CNS studies are unique; very different from trials in other indications that don’t involve the brain.  Drug developers working in psychiatric and neurological indications must document CNS activity, safety, pharmacokinetics, and pharmacodynamics.  It takes a company with expertise to deliver the early-phase data that launch an investigational new drug into late phase clinical development.

At Clinilabs Drug Development Corporation, we use our phase 1 unit to accelerate drug development programs so our customers can get new medicines to market faster.  From simple FIH/SAD/MAD studies to complex biomarker, kinetic/dynamic, proof-of-concept, and global multicenter projects, we have it all to ensure that your development program moves swiftly and seamlessly from early-phase to late-phase clinical trials.

Impeccable execution.  Quality.  Speed.  Enabled by unparalleled CNS project teams.

  • First in human

  • First in class

  • Single ascending dose (SAD)

  • Multiple ascending dose (MAD)

  • Bioequivalence (BE)

  • Drug – drug interaction studies

  • Drug – alcohol interactions studies

  • Food effect studies

  • Pharmacokinetic (PK) studies

  • Pharmacodynamic (PD) studies

  • Kinetic-dynamic relationships

I must say, I spend a lot of my time these days trying to persuade people that controlled trials are the only way to get information that’s reliable about drugs.

– Louis Lasagna