Safety and Tolerability of Zelquistinel in Normal Human Volunteers

NCT04981561 | Completed Phase 1 FDA Drug

• 1 other identifier: 3125-101-009
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Major Depressive Disorder

Keywords

NMDA receptor; NMDA receptor positive allosteric modulator; pharmacokinetics; biomarker; eeg

Outcome Measures

Primary Outcomes (1)

• Treatment emergent adverse events

  through study completion

  28 days

Secondary Outcomes (3)

• Pharmacokinetics, maximum plasma concentration

  24 hours

• Pharmacokinetics, time to maximum plasma concentration

  24 hours

• Pharmacokinetics, area under the curve for plasma concentration

  72 hours

Study Arms (10)

100 microgram zelquistinel

EXPERIMENTAL

zelquistinel, 100 microgram tablet, PO, Single Dose with 28 day follow up

Drug: zelquistinel

1 mg zelquistinel

EXPERIMENTAL

zelquistinel, 1 mg tablet, PO, Single Dose with 28 day follow up

Drug: zelquistinel

3 mg zelquistinel

EXPERIMENTAL

zelquistinel, 3 mg tablet, PO, Single Dose with 28 day follow up

Drug: zelquistinel

10 mg zelquistinel

EXPERIMENTAL

zelquistinel, 10 mg tablet, PO, Single Dose with 28 day follow up

Drug: zelquistinel

25 mg zelquistinel

EXPERIMENTAL

zelquistinel, 25 mg tablet, PO, Single Dose with 28 day follow up

Drug: zelquistinel

50 mg zelquistinel

EXPERIMENTAL

zelquistinel, 50 mg tablet, PO, Single Dose with 28 day follow up

Drug: zelquistinel

100 mg zelquistinel

EXPERIMENTAL

zelquistinel, 100 mg tablet, PO, Single Dose with 28 day follow up

Drug: zelquistinel

1 mg zelquistinel with CSF collection

EXPERIMENTAL

zelquistinel, 1 mg tablet, PO, Single Dose with 28 day follow up, with CSF collection

Drug: zelquistinel

10 mg zelquistinel with CSF collection

EXPERIMENTAL

zelquistinel, 10 mg tablet, PO, Single Dose with 28 day follow up, with CSF collection

Drug: zelquistinel

Placebo

PLACEBO COMPARATOR

Placebo tablet, PO, Single Dose with 28 day follow up

Drug: Placebo

Interventions

Placebo DRUG

Placebo

Placebo

zelquistinel DRUG

Single dose of zelquistinel

1 mg zelquistinel; 1 mg zelquistinel with CSF collection; 10 mg zelquistinel; 10 mg zelquistinel with CSF collection; 100 mg zelquistinel; 100 microgram zelquistinel; 25 mg zelquistinel; 3 mg zelquistinel; 50 mg zelquistinel

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Syndeio Biosciences, Inc: lead

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Aaron Koenig, MD

  Syndeio Biosciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double blind placebo controlled

Study Record Dates

• First Submitted: July 18, 2021
• First Posted: July 29, 2021
• Study Start: December 9, 2016
• Primary Completion: December 21, 2017
• Study Completion: December 21, 2017
• Last Updated: March 12, 2026

Record last verified: 2021-07