Trials / Completed
CompletedNCT01774045
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- BioLite, Inc. · Industry
- Sex
- All
- Age
- 20 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
Outcome measures: Physical examination, Vital sign, Electrocardiograph (ECG), Hematology, Blood chemistry, AEs/SAEs monitoring and Columbia-Suicide Severity Rating Scale (C-SSRS)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PDC-1421 | |
| DRUG | Placebo |
Timeline
- Start date
- 2012-11-01
- Primary completion
- 2013-07-01
- Completion
- 2013-07-01
- First posted
- 2013-01-23
- Last updated
- 2020-08-13
- Results posted
- 2014-09-22
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT01774045. Inclusion in this directory is not an endorsement.