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Biotechnology: Pharmaceutical Preparations
Clinical TrialOct 5, 2026, 05:11 PM

Equillium Receives Australian Approval for EQ504 Phase 1 Trial

AI Summary

Equillium, Inc. announced it has received Human Research Ethics Committee approval and clearance from the Therapeutic Goods Administration in Australia for its Phase 1 clinical trial of EQ504. The company expects to begin dosing healthy participants by early November 2026. The Phase 1 trial is a randomized, double-blinded, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of EQ504. It includes single ascending dose, multiple ascending dose with GI biopsies, and food effect cohorts.

Key Highlights

  • Equillium, Inc. received HREC approval and TGA clearance in Australia for its Phase 1 clinical trial of EQ504.
  • The Phase 1 trial will evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of EQ504 in healthy participants.
  • The trial includes a Single Ascending Dose part, a Multiple Ascending Dose part with GI biopsies, and a Food Effect Cohort.