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 |