Equillium Inc.
10/05/2026 | Press release | Distributed by Public on 10/05/2026 15:07
Material Event (Form 8-K)
| Item 8.01 |
Other Events. |
On October 5, 2026, Equillium, Inc. (the Company) 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 expects to begin dosing healthy participants by early November 2026.
About the Phase 1 Trial
The Phase 1 trial is a randomized, double-blinded, placebo-controlled, single-center study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of EQ504 in healthy participants, exploring once-daily oral doses ranging from 0.1 to 3.0 mg. The trial is structured into three distinct parts:
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Part A - Single Ascending Dose: Evaluates escalating, once-daily oral doses of EQ504 across five (5) sequential cohorts of healthy participants to determine initial safety parameters and PK. |
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Part B- Multiple Ascending Dose: Evaluates multiple escalating oral doses across three (3) cohorts, in healthy participants receiving once-daily dosing for ten (10) days to assess steady-state PK, safety, and cumulative tolerability. In addition to systemic plasma exposure and to validate the drug's localized mechanism of action, the study protocol incorporates gastrointestinal (GI) mucosal biopsies to be collected longitudinally during the study. A primary pharmacodynamic focus of these biopsies will include the assessment of key tissue-specific biomarkers, including Cytochrome P450 1A1 (CYP1A1) expression. These mechanistic tissue data are designed to confirm localized biological activity and provide target validation ahead of the Phase 2 proof-of-concept study. |
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Part C - Food Effect Cohort: A dedicated crossover cohort to evaluate the impact of a high-fat meal on the bioavailability and systemic exposure of a single oral dose of EQ504. |
Equillium Inc. published this content on October 05, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT) on October 05, 2026 at 21:07 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]