22: A Summary of Phase I Clinical Trials

Music City Center 

Phase I clinical trials are for finding the effective and safe dose for a new drug in humans. Phase I clinical trials are also known as toxicity trials. An objective for safety is to find the maximum tolerated dose (MTD). There are several different designs for finding MTD. These include the 3+3 design, P+Q design, BOIN design, and CRM design. The MTD is defined as the highest possible dose of a drug that achieves a treatment effect with out unwanted side effects. Phase II trials typically assess the efficacy of a drug and phase III trials compare the safety and efficacy of a drug with a standard of care or placebo. Phase IV trials look at a drug over a long period of time and in assess efficacy and safety.

Phase I clinical trials





maximum tolerated dose

3+3 design

P+Q design

BOIN design

CRM design 

Biopharmaceutical Section