A Dose Escalation Phase I Study of PDC-1421 Capsule Targeting in Depression
A Dose Escalation Phase I Study of PDC-1421 Capsule Targeting in Depression
The purpose of this study is to evaluate the safety of PDC-1421 Capsule in healthy subject,
 find the effective adequate dose for the next stage of the study, and accumulate information
 of possible mechanism of its anti-depressive effect.
Outcome measures: Physical examination, Vital sign, Electrocardiograph (ECG), Hematology,
 Blood chemistry, AEs/SAEs monitoring and Columbia-Suicide Severity Rating Scale (C-SSRS)
Inclusion Criteria:

 1. Aged 20-65 years.

 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.

 Exclusion Criteria:

 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.