A Phase I, Randomized, Double-Blind, Placebo-Controlled Study of EQ504 in Single and Multiple Ascending Doses in Healthy Volunteers
Phase 1 · Testing EQ504 · 1 site · Equillium
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing EQ504 (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 1 studies are early tests in a small group of people, mainly checking safety and dosing.
Who can join
- Ages 18 to 65
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- 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
There are also 9 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 70 participants are expected to take part.
- The study has 4 groups.
- Start date: 2026-10 (planned).
- Main results expected around 2027-04 (estimate from the record).
- 1 study site listed in Australia.
Groups in this study
- EQ504 Part A (listed as: experimental group)
- EQ504 Part B (listed as: experimental group)
- EQ504 Part C (listed as: experimental group)
- Placebo (listed as: placebo group)
Main thing being measured
- Incidence of Treatment Emergent Adverse Events (Part A up to Day 8, Part B up to Day 17, Part C up to Day 12)
In the researchers’ words
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…
Words you might see
- Placebo: a look-alike pill or injection with no active drug, used for comparison.
- Randomized: participants are put into groups by chance, like a coin flip.
- Biologic: a medicine made from living cells, usually given by injection or infusion.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Phase 1 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis |
| Lead sponsor | Equillium |
| Collaborators | Equillium AUS Pty Ltd |
| Enrollment | 70 (estimated) |
| Start date | 2026-10 |
| Primary completion (est.) | 2027-04 |
| First posted | 2026-10-09 |
| Last updated | 2026-10-09 |
| Official title | A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered EQ504 in Healthy Volunteers |
| ClinicalTrials.gov ID | NCT07869225 |
Interventions
- EQ504 (Drug)
EQ504 - EQ504 Placebo (Drug)
Placebo
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Veritus Research | Melbourne | Australia |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.