2. Subjects must be able to understand and willing to sign informed consent.
3. Female subjects of child-bearing potential must test negative to pregnancy and use appropriate birth control method from the beginning of study to the 15 days later after ending of study.
4. Laboratory data: red blood cell count(RBC),white blood cell count(WBC), platelets, hematocrit, hemoglobin, prothrombin time(PT), partial thromboplastin time (aPTT),aspartate transaminase(AST),alanine aminotransferase(ALT), Lactate dehydrogenase(LDH), total bilirubin, blood urea nitrogen(BUN),serum creatinine, free thyroxine (FT4), thyroid-stimulating hormone (TSH) level,sodium, potassium, calcium, glucose, are all within the normal range.
5. No significantly abnormal findings on physical examination, ECG and vital sign.
You may not be if
1. With any clinically significant neurological, gastrointestinal, renal, hepatic,cardiovascular, respiratory, metabolic, endocrine, hematological or other major disorders as determined by the Investigator.
2. A positive drug screen.
3. Any mental disorder diagnosed by board-certificated psychiatrist through detailed diagnostic interview.
4. Any history of suicidal behavior in the past 6 months when evaluated by the C-SSRS.
5. The intensity of suicidal ideation in the past 6 months is no less than 4 defined by the C-SSRS.
6. Have received any prescribed medicine, investigational drug or any non prescribed medicine (including herbal remedies) with 14 days prior to enroll this study.
Clareo Health | A Dose Escalation Phase I Study of PDC-1421 Capsule Targeting in Depression
