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COMPLETED
NCT03655873
PHASE1

The Study of a Selective 5-ht6 Receptor Antagonist, HEC30654AcOH,in Healthy Subjects

Sponsor: Sunshine Lake Pharma Co., Ltd.

View on ClinicalTrials.gov

Summary

This study is a safety, tolerability, and pharmacokinetics phase Ⅰstudy of a selective 5-ht6 receptor antagonist, HEC30654AcOH,in healthy subjects.This test is divided into two parts, the first part is the healthy adult subjects single ascending-dose research;The second part is the healthy adult subjects multiple ascending-dose research.

Official title: Safety, Tolerability, and Pharmacokinetics Phase ⅠStudy of a Selective 5-ht6 Receptor Antagonist, HEC30654AcOH, Following Single and Multiple Ascending Doses,Single-center, Randomized, Double-blind in Healthy Subjects

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

43

Start Date

2018-11-21

Completion Date

2019-12-17

Last Updated

2026-05-01

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

HEC30654AcOH capsule

single ascending-dose study: 5-、10-、15-、30-、60-、90-、120mg HEC30654AcOH capsule in day1. Multiple ascending-dose study: 15-、30-、60mgHEC30654AcOH capsule in day1-day7,2 times everyday.

DRUG

Placebo capsule

single ascending-dose study: 5-、10-、15-、30-、60-、90-、120mg placebo capsule in day1. Multiple ascending-dose study: 15-、30-、60mg placebo capsule in day1-day7,2 times everyday.

Locations (1)

First Hospital of Jilin University

Changchun, Jilin, China