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

NCT07869225 — Phase 1, Not yet recruiting, 70 participants, Equillium

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT07869225
Status	Not yet recruiting
Phase	Phase 1
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	70 (Estimated)
Sponsor	Equillium (Industry); collaborators: Equillium AUS Pty Ltd
Conditions	Ulcerative Colitis
Interventions	EQ504, EQ504 Placebo (Drug)
Dates	start 2026-10-01 (estimated), primary completion 2027-04-01 (estimated), completion 2027-05-01 (estimated), first posted 2026-10-09, last updated 2026-10-09
Locations	1 site in Australia

-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.

Expand all sections · Collapse all

+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.

+Arms and interventions

Arm	Type	Interventions	Description
EQ504 Part A	Experimental	Drug: EQ504	EQ504 administered in a blinded dose escalating cohort fashion by oral administration once daily on Day 1.
EQ504 Part B	Experimental	Drug: EQ504	EQ504 administered in a blinded dose escalating cohort fashion by oral administration once daily on Days 1-10.
EQ504 Part C	Experimental	Drug: EQ504	EQ504 administered in a blinded fashion by oral administration once on Day 1 (fasted) and Day 5 (fed).
Placebo	Placebo comparator	Drug: EQ504 Placebo	Placebo administered in a blinded fashion by oral administration.

EQ504 (Drug): EQ504
EQ504 Placebo (Drug): Placebo

+Outcome measures

Primary outcomes

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

Secondary outcomes

To characterize the PK of EQ504 - maximum observed plasma concentration (Cmax) [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) [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) [Part A through Day 4, Part B through Day 13, Part C through Day 8]
To characterize PD levels following administration of EQ504 [Part A through Day 4, Part B through Day 13, Part C through Day 8]

+Eligibility

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

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)

Facility	City	Country	Status
Veritus Research	Melbourne	Australia