The aim of the first clinical trials (phase
I) on humans is to help evaluate and understand the behavior
of the molecule
or compound on healthy subjects.
Clinical researchers and pharmacologists aim to establish the
pharmacodynamic and pharmacokinetic profile of the compound
for the first time on humans. Thus, they acquire deeper knowledge
of several parameters, including, for example :
- the impact of the molecule on the organism (metabolism, bone
tissue, blood, liver, brain activity, etc); various secondary
effects, etc.
- the differing reactions to the drug of men and women;
- the interaction between food and the absorption of the
drug.
The subjects are subjected to increasing doses so as
to determine both the minimal dose at which side-effects
can
be detected
and the maximum dose tolerated.
| Duration: around 18 months
These trials are carried out using a small number of
healthy subjects, generally between 100 and 200 people
divided into small groups of 10 to 20 subjects.
These tests are carried out with the help of the most
promising compounds (between one and five). Generally,
between 1 and 3 molecules will be selected for phase
II. |
Biomarkers and genetic tests are increasingly used to determine
the clinical effectiveness and safety of a drug. Should the drug prove to be more toxic than expected, or less
well tolerated by the body than anticipated, the trials are
immediately stopped. This stage facilitates the retention of only those compounds
with a promising pharmacokinetic profile
and little or no side-effects. |
