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

NCT07869225 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: EQ504-101
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment Emergent Adverse Events

  Number of participants with treatment-related adverse events

  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)

  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

Study Arms (4)

EQ504 Part A

EXPERIMENTAL

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

Drug: EQ504

EQ504 Part B

EXPERIMENTAL

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

Drug: EQ504

EQ504 Part C

EXPERIMENTAL

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

Drug: EQ504

Placebo

PLACEBO COMPARATOR

Placebo administered in a blinded fashion by oral administration.

Drug: EQ504 Placebo

Interventions

EQ504 DRUG

EQ504

EQ504 Part A; EQ504 Part B; EQ504 Part C

EQ504 Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Equillium: lead
• Equillium AUS Pty Ltd: collaborator

Study Sites (1)

Veritus Research

Melbourne, Australia

Location

Related Links

• Company website

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Clinical Trial Manager

CONTACT

858-240-1200; clinicaltrials@equilliumbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1 Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), and Optional Food Effects (FE) Healthy Volunteer study

Study Record Dates

• First Submitted: October 6, 2026
• First Posted: October 9, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: October 9, 2026

Record last verified: 2026-10

Locations

AU (1)