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NCT07869225Not yet recruitingPhase 1

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

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

Source: ClinicalTrials.gov · Last updated 9 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
70 (estimated)
First submitted
6 Oct 2026
Start date
Oct 2026
Primary completion date
Apr 2027
Lead sponsor
Equillium
NCT number
NCT07869225

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 70
  • From Oct 2026 to the primary completion date, Apr 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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)
  • 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
  • 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.

Other illness

  • History of chronic alcohol abuse or excessive alcohol intake
  • History of relevant drug hypersensitivity
  • Positive for HIV-1 or HIV-2, hepatitis B virus (HBV), or Hepatitis C virus (HCV)

Who the study is looking for

  • 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

Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Veritus Research
Coordinator of this site? Confirm its status
MelbourneAustraliaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.