termsTerm

First-in-human (FIH) trial

aka first-in-human, first in human, FIH, first-in-human trial, first-in-human study, first-in-class, first in class, first-in-patient, phase 0, microdose, investigational new drug, IND-enabling, IND clearance, clinical entry, entered the clinic, clinical-stage, preclinical, pre-clinical, preclinical-stage

The very first time a new drug is given to people, after animal and laboratory testing. In oncology these are phase 1 trials in patients with advanced cancer who have exhausted standard options, starting at a fraction of the dose predicted to be safe.

An Investigational New Drug application (or EU clinical trial authorisation) summarising toxicology, manufacturing and the protocol must be cleared before dosing. Starting doses derive from animal no-adverse-effect levels or, for immune agonists after the TGN1412 disaster, from minimal anticipated biological effect levels. First-in-class drugs (a new mechanism) carry more uncertainty than follow-on agents. Modern FIH trials are seamless: escalation, expansion and sometimes registrational cohorts in one protocol, so a first-in-human study can lead directly to accelerated approval (sotorasib, tarlatamab). 'Entering the clinic' marks a programme's transition from preclinical to clinical stage.

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Dose-escalation designs (3+3, BOIN, dose-expansion)Maximum tolerated dose (MTD)Seamless, adaptive and Bayesian trial designs Window-of-opportunity trial