{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-414364","form_type":"8-K","ticker":"EQ","cik":"0001746466","company_name":"Equillium, Inc.","filed_at":"2026-10-05T21:06:37+00:00","discovered_at":"2026-10-05T21:08:00.281619+00:00","generated_at":"2026-10-12T16:41:15.836446+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.5,"calibrated_materiality_score":0.5,"confidence":"high","headline":"Equillium wins Australian HREC and TGA clearance for Phase 1 EQ504 trial; dosing to start early November 2026","bullets":["Equillium received Human Research Ethics Committee approval and Therapeutic Goods Administration clearance in Australia under the Clinical Trial Notification scheme for a Phase 1 trial of EQ504.","Company expects to begin dosing healthy participants by early November 2026.","Phase 1 is a randomized, double-blinded, placebo-controlled, single-center study of once-daily oral EQ504 at doses from 0.1 mg to 3.0 mg.","Part A: single ascending dose across 5 cohorts; Part B: multiple ascending dose across 3 cohorts with 10 days of once-daily dosing to assess steady-state PK, safety and tolerability.","Part C: food-effect crossover cohort testing a high-fat meal's impact on bioavailability; longitudinal GI mucosal biopsies will assess CYP1A1 expression for target validation ahead of Phase 2."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-414364","json":"https://secwatch.observer/filing/0001193125-26-414364.json","markdown":"https://secwatch.observer/filing/0001193125-26-414364.md","text":"https://secwatch.observer/filing/0001193125-26-414364.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1746466/000119312526414364/0001193125-26-414364-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1746466/000119312526414364/d174431d8k.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-12T16:41:15.836446+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}