A team of scientists conducts a study to assess the pharmacologic qualities of oxfendazole, an antihelminthic drug. Healthy volunteers are given escalating oral dosages of oxfendazole (0.5 to 60 mg/kg) as part of the study. Data is gathered to create a pharmacokinetic profile of the medication and its metabolites, and the occurrence of side effects is documented for each dose level. The study includes 20 healthy male and female (nonchildbearing potential) subjects. Oxfendazole has been proven to be well tolerated over the whole dosage range, with no significant side effects or fatalities. Which of the following statements best defines this sort of research?

Question

Quizplus · Accepted Answer

Eductional Objective: The clinical trials process determines if novel therapies (for example, medications or procedures) are effective and safe for their intended purpose (i.e., illness treatment) in the target population (eg, subjects with the disease of interest). New therapies go through numerous research phases, some of which include no human participants (preclinical studies), while others involve few (phase I and II trials) or many (phase III and IV trials). Each of these phases has a distinct purpose.
A phase I trial is the initial step in human testing of a novel medicine. Data on the drug's pharmacokinetic profile, metabolism, and pharmacodynamic response are obtained (ie, how it affects the body). Various therapy approaches (for example, orally, intravenously) may also be studied. Human safety is assessed in terms of adverse effects and the maximum tolerated dose (MTD). Gradually increasing doses are typically administered to find the highest dose (ie, MTD) that does not cause unacceptable toxicity. Phase I trials usually include only a small number of healthy subjects.
Note: Cancer-related phase I trials may involve subjects with cancer (rather than healthy subjects) who have been unresponsive to other treatments.

A Team of Scientists Conducts a Study to Assess the Pharmacologic