This is a randomized, placebo-controlled, double-blinded single and multiple ascending dose (SAD and MAD) study of the safety, tolerability, and pharmacokinetics of EQU-001 in healthy volunteers.
EQU-001 is a Phase 1 randomized, placebo-controlled, double-blind SAD/MAD study to evaluate safety, tolerability, PK, and high-fat food effects on EQU-001. Eight healthy adult participants will be enrolled in each of up to 5 cohorts in both the SAD and MAD portions of the study (10 mg, 20 mg, 40 mg, 80 mg, and 120 mg). The participants will be randomized 3:1, drug to placebo. The MAD dosing is for 14 days, to include a period of time where the study drug will be at steady-state. Eight participants from the SAD study (the 40 mg dose cohort or the MTD dose cohort, whichever dose is lower) will also complete a fed portion of the study. This study of EQU-001 will provide baseline safety, tolerability, PK, and food effect data in healthy individuals and aims to identify drug-specific DLTs and an MTD. The PK component will characterize the PK of EQU-001 to inform dosing and may help to correlate exposures with any DLTs or other treatment-related AEs. The food effect component will characterize the effect of a high-fat meal on EQU-001 kinetics and exposure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
81
Clinical Pharmacology of Miami
Hialeah, Florida, United States
AEs Grade 2 or higher
As defined by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0, November 2017
Time frame: Up to 19 days
Change in pupil size from low light under high-light conditions between baseline and day 1 for part 1 (SAD) and day 14 for part 2 (MAD)
Time frame: day 1 SAD; day 14 MAD
Number of participants in each MAD cohort who discontinue the study drug because of study drug effects
Time frame: Up to 14 days
EQU-001 drug concentration in blood
Time frame: From pre-dose to 120 hours post dose in SAD and from pre-dose to 120 hours post the first and 14th doses in the MAD
Differences in EQU-001 drug concentrations in blood and in the parameters below under fasted as compared with fed conditions
Time frame: From pre-dose to 120 hours post dose
Incidence of DLTs
Time frame: up to 19 days
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