NCT03943251

The Study of a Selective Serotonin Partial Agonist and Reuptake Inhibitors, HEC113995PA•H2O,in Healthy Subjects

Safety, Tolerability, and Pharmacokinetics Phase ⅠStudy of a Selective Serotonin Partial Agonist and Reuptake Inhibitors, HEC113995PA•H2O, Following Single Ascending Doses，Single-center, Randomized, Double-blind in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Sunshine Lake Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is a safety, tolerability, and pharmacokinetics phase Ⅰstudy of a selective Serotonin partial agonist and reuptake inhibitors, HEC113995PA•H2O,in healthy subjects.This study is the healthy adult subjects single ascending-dose research.

Detailed description

There have set up seven dose group(2.5、5、10、20、40、60、80mg）.The first group(2.5mg)contains 8 health subjects(6 health subjects take experimental drugs,2 health subjects take the placebo). Other groups contains 10 health subjects(8 health subjects take experimental drugs,2 health subjects take the placebo).Within 30min before taking the medicine and after 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 24h, 36h, 48h,72h to take blood samples for pharmacokinetics(PK) detection.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	HEC113995PA•H2O tablet	2.5-、5-、10-、20-、40-、60-、80mg HEC113995PA•H2O tablet in day1.
DRUG	Placebo tablet	2.5-、5-、10-、20-、40-、60-、80mg Placebo tablet in day1.

Timeline

• Start date: 2019-07-04
• Primary completion: 2019-12-11
• Completion: 2019-12-11
• First posted: 2019-05-09
• Last updated: 2021-05-13

Locations

1 site across 1 country: China