Phase I blog
07 Mar 2019
There are many studies which could be included in Phase-1 studies. Amongst all those studies First In Man are the most important study as it is for the first time a new drug is being administered in the Human beings. It provides an idea about the Maximum tolerated Dose. The study is by and large conducted in the Healthy male subjects as a cohort of 6 to 8 subjects. There could be 4 to 6 cohorts in the study. Each cohort receives a Dose of the New Drug in the Ascending fashion, hence it is also called Single Ascending Dose study. In each cohort there could be a some subjects receiving active drug and very few receive placebo.
The PK samples are collected at various time intervals to understand the PK profile of the NCE. The results of it will help in designing the next step- MAD ( Multiple Ascending Dose) study.
Invariably the Biomarkers are also used to understand the profile of the drug and to evaluate the safety. It has to be conducted in a special unit with Cardiac monitors with Central monitoring facility, Holter Monitors, Telemetry, etc.
Lambda has a specially designed Phase-1 unit where such studies are conducted.