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

NCT05004571 | Completed Phase 1 FDA Drug

• 1 other identifier: EQU-101
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Healthy; Adult; Volunteer

Outcome Measures

Primary Outcomes (2)

• AEs Grade 2 or higher

  As defined by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0, November 2017

  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)

  day 1 SAD; day 14 MAD

Secondary Outcomes (4)

• Number of participants in each MAD cohort who discontinue the study drug because of study drug effects

  Up to 14 days

• EQU-001 drug concentration in blood

  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

  From pre-dose to 120 hours post dose

• Incidence of DLTs

  up to 19 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Matched placebo control 10 mg capsules or 20 mg capsules totaling 20 mg, 40 mg, 80 mg, or 120 mg will be given once orally to placebo subjects in the SAD portion of the study. 10 mg capsules or 20 mg capsules totaling 20 mg, 40 mg, 80 mg, or 120 mg will be given once daily for 14 days orally to placebo subjects in the SAD portion of the study.

Drug: Placebo

Study drug EQU-001

EXPERIMENTAL

10 mg capsules or 20 mg EQU-001 capsules totaling 20 mg, 40 mg, 80 mg, or 120 mg will be given once orally to active-treatment subjects in the SAD portion of the study. 10 mg capsules or 20 mg EQU-001 capsules totaling 20 mg, 40 mg, 80 mg, or 120 mg will be given once daily for 14 days orally to active treatment subjects in the SAD portion of the study.

Drug: EQU-001

Interventions

EQU-001 DRUG

EQU-001 in 10 and 20 mg capsules

Study drug EQU-001

Placebo DRUG

Matched placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 65 years of age
• Weight 60 kg to 90 kg
• Willing and able to
• communicate in English or Spanish
• provide written informed consent to take part in the study
• be available for all visits and able and willing to comply with all study procedural requirements
• In general good health in the opinion of the investigator as defined by:
• The absence of clinically significant neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease including uncontrolled diabetes.
• Agree not to participate in other concurrent interventional and/or drug trials
• Agree not to use nicotine containing products
• Agree not to eat grapefruit, drink grapefruit juice or take St. John's wort for 5 days prior to study drug dosing and throughout the study.
• If you or your heterosexual partner is pre-menopausal, you must agree to use an effective method of contraception and to continue use of an effective method for the duration of study participation and 2 weeks after. For this study, a clinical history of amenorrhea for ≥1 year without a separate identifiable cause and a medical history consistent with menopause meets criteria for post-menopausal. Acceptable methods are:
• condom use together with an additional barrier method plus spermicide, hormonal methods, or an IUD
• sterilization of participant or partner
• heterosexual abstinence

You may not qualify if:

• Pregnant or lactating
• History of hypersensitivity to the EQU-001 API
• History of EQU-001 API use within the previous 2 weeks
• History of ocular conditions that interfere with pupillometry including inability to focus on an object 3 meters in front of them, current eye disorder under the care of an ophthalmologist, or pupil not readily distinguishable from the iris
• History of excessive caffeine use (\>8 cups of coffee or caffeine-containing energy drinks per day)
• History of smoking or vaping within the past 3 months
• History of substance abuse within 6 months (with the exception of medically indicated marijuana), including alcohol
• Use of concomitant prescription medications within 5 days of the study drug dose
• Use of an investigational drug or device or participation in an investigational study within 30 days prior to enrollment
• Donation of blood within the previous 4 weeks
• Has any of the following laboratory abnormalities at screening or baseline:
• Breathalyzer result ≥ 0.1
• Positive COVID test
• Positive urine drug screen
• Positive urine cotinine screen

Sponsors & Collaborators

• Equilibre Biopharmaceuticals B.V.: lead

Study Sites (1)

Clinical Pharmacology of Miami

Hialeah, Florida, 33104, United States

Location

Study Officials

• Amy Melsaether, MD

  Equilibre Biopharmaceuticals B.V.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 3:1 treatment to placebo

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 13, 2021
• Study Start: July 6, 2021
• Primary Completion: September 4, 2021
• Study Completion: September 4, 2021
• Last Updated: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)