NCT04981561

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Syndeio Biosciences, Inc · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	zelquistinel	Single dose of zelquistinel
DRUG	Placebo	Placebo

Timeline

• Start date: 2016-12-09
• Primary completion: 2017-12-21
• Completion: 2017-12-21
• First posted: 2021-07-29
• Last updated: 2026-03-12

Regulatory

• FDA-regulated drug study