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Starting soon Phase 1

A Phase I, Randomized, Double-Blind, Placebo-Controlled Study of EQ504 in Single and Multiple Ascending Doses in Healthy Volunteers

NCT07869225 · tracked via the Priya Life Science Australia tracker
Sponsor
Equillium
Phase
Phase 1
Started
2026-10
Last updated
2026-10-09

Condition(s) studied

Ulcerative Colitis

Investigational drug(s) / intervention(s)

EQ504EQ504 Placebo

EQ504: EQ504

EQ504 Placebo: Placebo

Study summary

This is a Phase 1, first in human, three-part randomized, double-blind, placebo-controlled dose escalation trial to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of EQ504 following single ascending dose (SAD) and multiple ascending dose administration (MAD), and an optional food effect (FE) cohort in healthy volunteers. The study will be conducted at a single site. Approximately 40 subjects will be enrolled in SAD, 30 in MAD, and 8 in FE.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Males and females 18 to 65 years of age inclusive * Body mass index (BMI) 18 to 32 kg/m2, with a body weight greater than or equal to 55kg * Medically healthy without clinically significant abnormalities * Have suitable venous access for blood sampling Exclusion Criteria: * History of chronic alcohol abuse or excessive alcohol intake * History of substance abuse or drug addiction within 1 year prior to first study drug administration and positive drug test results * Smoke more than 5 nicotine containing products or equivalent per month or who are not willing to abstain from smoking 7 days prior to admission and during the confinement period(s) * History of relevant drug hypersensitivity * Receiving or has received any investigational drug (biologic or small molecule) or is currently using an investigational device, within 3 months prior to trial Day 1 * Positive for HIV-1 or HIV-2, hepatitis B virus (HBV), or Hepatitis C virus (HCV) * Donation or receipt of blood or blood products within 90 days prior to screening * Past or intended use of over-the-counter or prescription medication (except for contraceptives), including herbal medications and AhR modulators (approved or investigational drug) within 14 days or 5 half-lives, whichever is longer, prior to dosing or during the trial * Live vaccine(s) within 1 month prior to Screening or plans to receive such vaccines during the trial.

Primary outcome measure(s)

  • Incidence of Treatment Emergent Adverse Events — Part A up to Day 8, Part B up to Day 17, Part C up to Day 12
    Number of participants with treatment-related adverse events

Trial sites (1)

FacilityCityRegionStatus
Veritus Research Melbourne Australia
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07869225 on ClinicalTrials.gov ↗ ← All trials in Australia