Ulcerative ColitisPhase 1NCT07869225
A Phase I, Randomized, Double-Blind, Placebo-Controlled Study of EQ504 in Single and Multiple Ascending Doses in Healthy Volunteers
A Phase 1 study testing EQ504 in people with Ulcerative Colitis, run by Equillium at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- EQ504
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2026to May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Conditions
- Ulcerative Colitis
- Being tested
- EQ504, EQ504 Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EQ504Drug
EQ504
EQ504 PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| EQ504 Part A | Experimental | EQ504 administered in a blinded dose escalating cohort fashion by oral administration once daily on Day 1. Receives: Drug: EQ504 |
| EQ504 Part B | Experimental | EQ504 administered in a blinded dose escalating cohort fashion by oral administration once daily on Days 1-10. Receives: Drug: EQ504 |
| EQ504 Part C | Experimental | EQ504 administered in a blinded fashion by oral administration once on Day 1 (fasted) and Day 5 (fed). Receives: Drug: EQ504 |
| Placebo | Placebo comparator | Placebo administered in a blinded fashion by oral administration. Receives: Drug: EQ504 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment Emergent Adverse Events
Number of participants with treatment-related adverse events
Measured: Part A up to Day 8, Part B up to Day 17, Part C up to Day 12
Secondary outcomes (4)
To characterize the PK of EQ504 - maximum observed plasma concentration (Cmax)
Measured: Part A through Day 4, Part B through Day 13, Part C through Day 8
To characterize the PK of EQ504 - time to maximum plasma concentration (Tmax)
Measured: Part A through Day 4, Part B through Day 13, Part C through Day 8
To characterize the PK of EQ504 - terminal elimination half-life (T 1/2)
Measured: Part A through Day 4, Part B through Day 13, Part C through Day 8
To characterize PD levels following administration of EQ504
Measured: Part A through Day 4, Part B through Day 13, Part C through Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 1 Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), and Optional Food Effects (FE) Healthy Volunteer study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Equillium
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Equillium AUS Pty Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869225
- Sponsor's protocol ID
- EQ504-101
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- EQ504-101
- Conditions
- Ulcerative Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- EquilliumIndustry (pharma, biotech, devices)
- Collaborators
- Equillium AUS Pty Ltd
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Phase 1 Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), and Optional Food Effects (FE) Healthy Volunteer study
| Arm | Type | Receives |
|---|---|---|
| EQ504 Part A | Experimental | Drug: EQ504EQ504 administered in a blinded dose escalating cohort fashion by oral administration once daily on Day 1. |
| EQ504 Part B | Experimental | Drug: EQ504EQ504 administered in a blinded dose escalating cohort fashion by oral administration once daily on Days 1-10. |
| EQ504 Part C | Experimental | Drug: EQ504EQ504 administered in a blinded fashion by oral administration once on Day 1 (fasted) and Day 5 (fed). |
| Placebo | Placebo comparator | Drug: EQ504 PlaceboPlacebo administered in a blinded fashion by oral administration. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EQ504EQ504 | Drug | EQ504 Part A, EQ504 Part B, EQ504 Part C |
| EQ504 PlaceboPlacebo | Drug | Placebo |
Primary outcome
Incidence of Treatment Emergent Adverse Events
Time frame: 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
4 secondary outcomes
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Company websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EQ504 in people with Ulcerative Colitis, run by Equillium at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Manager (858-240-1200, clinicaltrials@equilliumbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment Emergent Adverse Events (time frame: Part A up to Day 8, Part B up to Day 17, Part C up to Day 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.