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

NCT05004571 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2023-02-01

No results posted yet for this study

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.

Conditions

  • Safety Issues

Interventions

DRUG

EQU-001

EQU-001 in 10 and 20 mg capsules

DRUG

Placebo

Matched placebo

Sponsors & Collaborators

  • Equilibre Biopharmaceuticals B.V.

    lead INDUSTRY

Principal Investigators

  • Amy Melsaether, MD · Equilibre Biopharmaceuticals B.V.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-06
Primary Completion
2021-09-04
Completion
2021-09-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05004571 on ClinicalTrials.gov