The Shanghai xuhui district central hospital
Shanghai, Shanghai Municipality, China
NCT Number: NCT04194242
This study is a safety, tolerability, and pharmacokinetics phase Ⅰstudy of HEC96719, in healthy subjects.This study is the healthy adult subjects single ascending-dose research
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Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Shanghai, Shanghai Municipality, China
This study will evaluate the safety and tolerability of escalating single oral doses of HEC96719, and characterize the single-dose pharmacokinetics (PK) of HEC96719. Participants will receive either HEC96719 or HEC96719 placebo.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
0.1、0.2、0.5、1、2、3、4 mg HEC96719 tablet in day1
0.1、0.2、0.5、1、2、3、4 mg Placebo tablet in day1
Time frame: From the baseline to day7
To assess the safe and tolerability of the single ascending-dose
Time frame: At pre-defined intervals from Days 1-2
Maximum Plasma Concentration(Cmax)of HEC96719 in single ascending dose
Time frame: At pre-defined intervals from Days 1-2
Area Under the Curve(AUC) of HEC96719 in single ascending dose
Time frame: At pre-defined intervals from Days 1-2
Maximum Peak Time(Tmax) of HEC96719 in single ascending dose
Time frame: At pre-defined intervals from Days 1-2
Terminal elimination half-life(T1/2) of HEC96719 in single ascending dose
Sunshine Lake Pharma Co., Ltd.
Industry
A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Access the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HEC96719 Tablets in Chinese Healthy Volunteers
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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