Equillium, Inc.: receives TGA clearance for Phase 1 trial of EQ504

What happened On Oct 5, 2026, Equillium, Inc. announced that the Company has received Human Research Ethics Committee approval and clearance from the Therapeutic Goods Administration in Australia under the Clinical Trial Notification scheme for its Phase 1 clinical trial of EQ504. The Company announced it expects to begin dosing healthy participants by early Nov 2026.

Key details

• The Phase 1 trial is a randomized, double-blinded, placebo-controlled, single-center study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of EQ504 in healthy participants.
• Dosing will explore once-daily oral doses ranging from 0.1 to 3.0 mg.
• The trial is structured in three parts: Part A single ascending dose across five cohorts; Part B multiple ascending dose across three cohorts with once-daily dosing for 10 days; Part C a food effect crossover cohort testing a high-fat meal impact on a single dose.
• The protocol includes longitudinal gastrointestinal mucosal biopsies to assess tissue biomarkers, including Cytochrome P450 1A1 (CYP1A1) expression.

Why it may matter This report was filed as Item 8.01 (Other events) and covers regulatory approvals in Australia and the planned initiation timing and design of the Phase 1 trial of EQ504. The filing does not show why the company acted.