Safety and Tolerability of Zelquistinel in Normal Human Volunteers

Syndeio Biosciences, Inc68 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Major Depressive Disorder

Interventions

zelquistinelDRUG

Single dose of zelquistinel

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Treatment emergent adverse events

through study completion

Time frame: 28 days

Secondary Outcomes

Pharmacokinetics, maximum plasma concentration

maximum plasma concentration

Time frame: 24 hours

Pharmacokinetics, time to maximum plasma concentration

time to maximum plasma concentration

Time frame: 24 hours

Pharmacokinetics, area under the curve for plasma concentration

area under the curve, plasma calculated 0-infinity

Time frame: 72 hours

Data from ClinicalTrials.gov

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