NCT05004571

Safety, Tolerability, and Pharmacokinetics of EQU-001 in Healthy Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Equilibre Biopharmaceuticals B.V. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Safety Issues

Interventions

Type	Name	Description
DRUG	EQU-001	EQU-001 in 10 and 20 mg capsules
DRUG	Placebo	Matched placebo

Timeline

• Start date: 2021-07-06
• Primary completion: 2021-09-04
• Completion: 2021-09-04
• First posted: 2021-08-13
• Last updated: 2023-02-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study