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Safety and Tolerability of Single and Multiple Ascending Doses of GATE-101 in Normal Human Volunteers | Clinical Trials | Clareo Health

TERMINATEDPHASE1

Safety and Tolerability of Single and Multiple Ascending Doses of GATE-101 in Normal Human Volunteers

A Randomized Double-blind, Placebo-controlled Single and Multiple Intravenous Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of GATE-101 in Normal Healthy Volunteers

NCT04618263•Syndeio Biosciences, Inc

View on ClinicalTrials.gov

Summary

To evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of GATE-101 in normal human volunteers

Detailed Description

Single ascending dose (SAD), multiple ascending dose (MAD), double-blind placebo-controlled study in normal human volunteers. Secondary objectives: To evaluate the pharmacokinetics (PK) of GATE-101 following increasing single and multiple doses of intravenously (IV) administered GATE-101. GATE-101 or Placebo: Dose/Mode of Administration: Single or 5 Daily Doses;Intravenous

Eligibility

Age

18 - 40 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Normal, healthy volunteer male and female subjects
•2. Aged 18 to 40 years
•3. For female subjects must meet one of the following:
•* Surgically sterile or at least 2 years menopausal, confirmed by follicle stimulating hormone (FSH) at screening visit, or,
•* If of childbearing potential, subject must use an acceptable method of birth control from date of screening to at least 30 days after the last dose of study drug. Must have a documented negative blood or urine pregnancy test within 24 hours prior to dosing. If reported sterile or postmenopausal, will be confirmed by FSH.
•4. For male subjects, must meet one of the following:
•* Surgically sterile
•* If not surgically sterile then use of an acceptable form of contraception (condom) from the time of randomization through 30 days following the last dose of study drug. Male subjects are strongly advised to inform female partners of the need for them to use highly effective birth control during this time period.
•5. Body mass index (BMI) \< 30
•6. Clinical laboratory values \<2 times the upper limit of normal (ULN) or deemed not clinically significant by the Investigator.
+1 more criteria

Exclusion Criteria

•1. Human immunodeficiency virus (HIV) infection, or hepatitis or other ongoing infectious disease
•2. Evidence of alcohol abuse (greater than 4 units of alcohol on most days; 1 unit = 1/2 pint of beer, 1 glass of wine or 1 oz. of spirits). Alcohol consumption should be avoided for at least 24 hours prior to baseline/dosing visit. A positive alcohol breathalyzer at screening and baseline visit
•3. Current abuse of illicit substances, using the Diagnostic and Statistical Manual (DSM) V definition of substance use disorder.
•4. Current cigarette/tobacco smoker or use of other tobacco or nicotine products including ecigarettes or vaping (if formerly a smoker must not have smoked for at least one year prior to enrolling in this study). Nonsmoking will be confirmed by cotinine assay.
•5. Currently pregnant, planning to become pregnant during the course of the study, or nursing mother
•6. Impaired renal function (GFR \< 90 ml/min)
•7. Elevated systolic blood pressure (\> 130 mmHg) or diastolic blood pressure (\> 80 mmHg) and/or increased QTc (\>450 msec for men or \>470 msec for women) or additional risk factors for Torsades de Pointes including heart failure, hypokalemia, family history of Long QT Syndrome
•8. Type I or Type II diabetes
•9. Malignancy in the last 5 years, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix
•10. Currently taking prescription (except as listed in Section 7.4.1) or over-the-counter medications including herbal therapies, within 14 days of enrollment into the study.
+8 more criteria

Locations (1)

Clinilabs Drug Development Corporation

Eatontown, New Jersey, United States

Key Dates

Start Date

October 26, 2020

Primary Completion Date

August 13, 2021

Completion Date

August 13, 2021

Last Updated

August 3, 2022

Enrollment

ACTUAL participants

Conditions

Major Depressive DisorderExcessive Sleepiness

Interventions

GATE-101

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 3, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Tolerability of Single and Multiple Ascending Doses of GATE-101 in Normal Human Volunteers

Inclusion Criteria

Exclusion Criteria

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