Major aim of phase 1 clinical trials is to know the
Phase I trial is designed as a dose-escalation study to determine the maximum tolerable dosage (MTD), that is, the maximum dose associated with an acceptable level of dose-limiting toxicity. Phase 1 Clinical Trials: The drug is tested in healthy human volunteers (extremes of ages ; elderly and children are excluded). As the drug is not tested in the patients, so we cannot determine efficacy in this phase. This is mainly for finding the maximum tolerable dose of the drug. This is first in human study. Because anti-cancer drugs can produce unacceptable toxicity and we cannot expose healthy humans to such a toxicity, the phase-1 trials for anticancer drugs are done in the patients
Safety
Efficacy
Maximum Tolerable Dose
Pharmacokinetics
CLINICAL TRIALS, DRUG LABEL