other material
confidence high
sentiment positive
materiality 0.50
Equillium wins Australian HREC and TGA clearance for Phase 1 EQ504 trial; dosing to start early November 2026
Equillium, Inc.
- 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.