A Dose Escalation Phase I Study of PDC-1421 Capsule Targeting in Depression

A Dose Escalation Phase I Study of PDC-1421 Capsule to Evaluate the Safety in Healthy Volunteers

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.