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Lead
Syndeio Biosciences, Inc
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
Age
18–45
Sex
ALL
Healthy volunteers
Accepted
You may be eligible 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 be 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
