{"entity":{"id":"first-in-human","kind":"term","name":"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","first-in-human studies","first-in-human trials"],"tldr":"The first time a new drug is given to people, after animal and laboratory testing and clearance of an Investigational New Drug application. 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; modern designs run straight through to registrational cohorts.","summary":"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.","asOf":"2026-09-09","wikipedia":"https://en.wikipedia.org/wiki/Phase_I_clinical_trial","links":[{"label":"Wikipedia","url":"https://en.wikipedia.org/wiki/Phase_I_clinical_trial"}],"tags":[],"related":["dose-escalation-design","mtd","seamless-adaptive","window-of-opportunity-trial","trial-lifecycle","trial-phases","ethics-review","informed-consent"],"cancers":[],"sections":["drug-discovery"],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"category":"Trials"},"route":"/terms/first-in-human/","neighbours":{"term":[{"id":"dose-escalation-design","kind":"term","name":"Dose-escalation designs (3+3, BOIN, dose-expansion)","route":"/terms/dose-escalation-design/"},{"id":"ethics-review","kind":"term","name":"Ethics review (IRB, research ethics committee)","route":"/terms/ethics-review/"},{"id":"informed-consent","kind":"term","name":"Informed consent","route":"/terms/informed-consent/"},{"id":"mtd","kind":"term","name":"Maximum tolerated dose (MTD)","route":"/terms/mtd/"},{"id":"trial-phases","kind":"term","name":"Phase 1, 2 and 3 trials","route":"/terms/trial-phases/"},{"id":"seamless-adaptive","kind":"term","name":"Seamless, adaptive and Bayesian trial designs","route":"/terms/seamless-adaptive/"},{"id":"trial-lifecycle","kind":"term","name":"Trial lifecycle: from protocol to label","route":"/terms/trial-lifecycle/"},{"id":"window-of-opportunity-trial","kind":"term","name":"Window-of-opportunity trial","route":"/terms/window-of-opportunity-trial/"}],"section":[{"id":"drug-discovery","kind":"section","name":"Drug Discovery Platforms","route":"/fronts/drug-discovery/"}],"journal":[{"id":"medical-oncology","kind":"journal","name":"Medical oncology","route":"/journals/medical-oncology/"},{"id":"oncology-research","kind":"journal","name":"Oncology research","route":"/journals/oncology-research/"}],"trial":[{"id":"target-national","kind":"trial","name":"TARGET National","route":"/trials/target-national/"}]}}