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

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

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