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.
Impeccable execution. Quality. Speed. Enabled by unparalleled CNS project teams.
First in human
First in class
Single ascending dose (SAD)
Multiple ascending dose (MAD)
Drug – drug interaction studies
Drug – alcohol interactions studies
Food effect studies
Pharmacokinetic (PK) studies
Pharmacodynamic (PD) studies
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