Phase I dose-escalation studies are the first step in human trials.
They usually involve a small number of participants.
Most are conducted in patients, especially in cancer research.
The main goal is safety.
Researchers aim to find a safe dose range.
Efficacy is not the primary focus.
Dose escalation is done gradually.
Patients receive increasing doses in cohorts.
Careful monitoring follows each step.
The 3+3 design is commonly used.
Three patients start at a low dose.
More patients are added if toxicity appears.
Dose-limiting toxicity is closely tracked.
These are serious side effects linked to the drug.
They guide dose decisions.
The maximum tolerated dose is a key outcome.
It is the highest dose with acceptable toxicity.
This dose informs later trial phases.
Pharmacokinetics are also studied.
Researchers observe how the drug moves in the body.
Absorption and clearance are measured.
Pharmacodynamics provide additional insight.
They show how the drug affects biological targets.
Early signals of activity may appear.
Ethical oversight is critical.
Informed consent is mandatory.
Patient safety remains the top priority.
Phase I dose-escalation studies set the foundation.
They shape Phase II and Phase III trials.
Their role is essential in drug development.