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Not yet recruitingNCT07869225Updated Oct 9, 2026

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

A Phase 1 interventional study of EQ504 and EQ504 Placebo in Ulcerative Colitis, sponsored by Equillium. Not yet recruiting at 1 site in Australia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-09.

Sponsored by Equillium · Phase 1, Interventional, and Treatment

Updated Oct 9, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

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.

Read the detailed description

Part A: Single Ascending Dose (SAD) is designed to evaluate the safety, tolerability, PK and PD or orally administered EQ504 in healthy volunteers. Up to approximately 40 participants will be randomized to 5 cohorts (n=8 per cohort). Dosing in each cohort will commence with two sentinel participants.

Part B: Multiple Ascending Dose (MAD) will randomize up to approximately 30 participants to 3 cohorts (n=10 per cohort).

Part C: Food Effect (FE) is optional. The selected SAD cohort will continue directly into the FE cohort (n=8). Participants will be administered EQ504 orally on Day 5 in a fed state.

02

Conditions studied

  • Ulcerative Colitis

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03

In context

Colitis, Ulcerative

1,530 studies on the registry are indexed under Colitis, Ulcerative; 407 are open to participants now.

This study's planned enrollment of 70 is close to the median of 70 across 1,069 interventional studies indexed under Colitis, Ulcerative.

Browse Colitis, Ulcerative studies →

Lead sponsor

Equillium is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    EQ504 Part A

    EQ504 administered in a blinded dose escalating cohort fashion by oral administration once daily on Day 1.

    Drug: EQ504

  • Experimental
    EQ504 Part B

    EQ504 administered in a blinded dose escalating cohort fashion by oral administration once daily on Days 1-10.

    Drug: EQ504

  • Experimental
    EQ504 Part C

    EQ504 administered in a blinded fashion by oral administration once on Day 1 (fasted) and Day 5 (fed).

    Drug: EQ504

  • Placebo comparator
    Placebo

    Placebo administered in a blinded fashion by oral administration.

    Drug: EQ504 Placebo

Interventions

  • DrugEQ504

    EQ504

  • DrugEQ504 Placebo

    Placebo

06

What researchers measure

Primary outcomes

  1. Incidence of Treatment Emergent Adverse Events

    Number of participants with treatment-related adverse events

    Time frame: Part A up to Day 8, Part B up to Day 17, Part C up to Day 12

Secondary outcomes

  1. To characterize the PK of EQ504 - maximum observed plasma concentration (Cmax)

    Time frame: Part A through Day 4, Part B through Day 13, Part C through Day 8

  2. To characterize the PK of EQ504 - time to maximum plasma concentration (Tmax)

    Time frame: Part A through Day 4, Part B through Day 13, Part C through Day 8

  3. To characterize the PK of EQ504 - terminal elimination half-life (T 1/2)

    Time frame: Part A through Day 4, Part B through Day 13, Part C through Day 8

  4. To characterize PD levels following administration of EQ504

    Time frame: Part A through Day 4, Part B through Day 13, Part C through Day 8

07

Study locations

1 site
  • Veritus Research
    Melbourne, Australia
    • Trial Advancement · Contact
08

References and documents

Related links

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 9, 2026
Show all 1 update
  1. Oct 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07869225
Lead sponsor
Equillium
Collaborators
Equillium AUS Pty Ltd
Responsible party
Sponsor
First posted
Oct 9, 2026
Start date
Oct 2026 (estimated)
Primary completion
Apr 2027 (estimated)
Completion
May 2027 (estimated)
Last update
Oct 9, 2026

Study contacts

Clinical Trial Manager
Contact
clinicaltrials@equilliumbio.com
858-240-1200

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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