Phase II

Phase II clinical trials are used to study the safety and efficacy of the drug. It is the phase of research where preliminary data is found to see if the drug works on people who have the condition or disease. This data is used to determine if there is sufficient biological activity against the disease to warrant further testing in Phase III.

Dose escalation is continued during this phase to find the lowest effective dose.

Phase II trials include several 100 volunteers, which allows the study of short-term adverse events and risks.

Source: Glossary of Common Site Terms – (n.d.). Clinicaltrials.Gov. Retrieved January 7, 2022, from