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Safety and Tolerability of Zelquistinel in Normal Human Volunteers | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Safety and Tolerability of Zelquistinel in Normal Human Volunteers

A Phase 1, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AGN-241751 After Oral Administration in Healthy Volunteers

NCT04981561•Syndeio Biosciences, Inc

View on ClinicalTrials.gov

Summary

To evaluate the safety and tolerability of single ascending doses of zelquistinel in normal human volunteers

Detailed Description

Single ascending dose (SAD), double-blind placebo-controlled study in normal human volunteers. Secondary objectives: To evaluate the pharmacokinetics (PK) and eeg biomarker of target engagement of zelquistinel following increasing single doses of zelquistinel. Zelquistinel or Placebo: Dose/Mode of Administration: Single dose; oral

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Agree to effective method of birth control
•If female, negative pregnancy test at screening and Day -1
•Nonsmoking at least 2 years
•BMI 18-30
•Supine pulse rate 30-100

Exclusion Criteria

•Known hypersensitivity to NMDA receptor drugs
•clinically significant disease in any body system
•QTcF \> 430 ms in males, \>450 ms in females
•positive test for hepatitis B or C
•abnormal liver function tests on Day -1
•History of alcohol or other substance abuse during the previous 5 years
•Positive drug screen at screening or Day -1
•Taken any medication within the past 14 days

Key Dates

Start Date

December 9, 2016

Primary Completion Date

December 21, 2017

Completion Date

December 21, 2017

Last Updated

March 12, 2026

Enrollment

ACTUAL participants

Conditions

Major Depressive Disorder

Interventions

zelquistinel

DRUG

Placebo

DRUG

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

NCT07115329

Major Depressive Disorder

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RECRUITINGPHASE3

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

NCT06793397

Major Depressive Disorder (MDD)Depression in Adults+4 more

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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: March 12, 2026Data 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 Zelquistinel in Normal Human Volunteers

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

Accelerated Intermittent Theta Burst Stimulation for Adolescent and Young Adult Depression With Elevated Suicide Risk

Validating the On-line Creyos Cognitive Assessment Platform in Older Adults With Major Depressive Disorder or Mild Cognitive Impairment

University of Iowa Interventional Psychiatry Service Patient Registry

Preliminary Efficacy Trial of a Digital Intervention for Depression and Cannabis Use