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.
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
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
Parallel
EQ504
DrugEQ504
EQ504 Placebo
DrugPlacebo
Incidence of Treatment Emergent Adverse Events
Number of participants with treatment-related adverse events
To characterize the PK of EQ504 - maximum observed plasma concentration (Cmax)
To characterize the PK of EQ504 - time to maximum plasma concentration (Tmax)
To characterize the PK of EQ504 - terminal elimination half-life (T 1/2)
To characterize PD levels following administration of EQ504
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Equillium
Lead sponsor
Equillium AUS Pty Ltd
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
