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Completed

NCT Number: NCT04981561

Safety and Tolerability of Zelquistinel in Normal Human Volunteers

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

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

zelquistinel

Drug

Single dose of zelquistinel

Placebo

Drug

Placebo

Primary outcomes

  1. Treatment emergent adverse events

    Time frame: 28 days

    through study completion

Secondary outcomes

  1. Pharmacokinetics, maximum plasma concentration

    Time frame: 24 hours

    maximum plasma concentration

  2. Pharmacokinetics, time to maximum plasma concentration

    Time frame: 24 hours

    time to maximum plasma concentration

  3. Pharmacokinetics, area under the curve for plasma concentration

    Time frame: 72 hours

    area under the curve, plasma calculated 0-infinity

Sponsors and collaborators

Lead sponsor

Syndeio Biosciences, Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 29, 2021
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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