Phases

Dosing

Number of subjects

Main goal of clinical phase

Preclinical

Unrestricted

Not applicable

Testing in non-humans (efficacy, toxicities, pharmacokinetics)

0

Subtherapeutic

About 10

Pharmacokinetics and pharmacodynamics

IA/IB

Ascending doses

20 - 100

Dose-ranging

IIA/IIB

Therapeutic dose

100 - 300

Drug efficacy

IIIA/IIIB

Therapeutic dose

1000 - 2000

Therapeutic effect

IV

Therapeutic dose

Anyone seeking treatment

Long-term effects

V

No dosing

All reported use

Research on data collected