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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04546984
Other study ID # HEC96719-P-02/CRC-C2028
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 14, 2020
Est. completion date December 29, 2020

Study information

Verified date May 2021
Source Sunshine Lake Pharma Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The Safety, Tolerability, Pharmacokinetic, Pharmacodynamics and Food Effect Study of HEC96719 in Healthy Subjects


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date December 29, 2020
Est. primary completion date December 29, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - Willing to participate in the study, able to understand and sign the informed consent, and able to complete the the study in accordance with the requirements of the study. - Female subjects who are not pregnant or lactating and male subjects whose female partners are fertile shall voluntarily take effective contraceptive measures from the date of signing the informed consent form to 3 months after the medication. - When signing the informed consent, 18 years old =the age=45 years old(including the critical value), gender is not limited. - Male body weight =50kg, female body weight =45kg, and body mass index (BMI) in the range of 18-28 kg/m2 (including the critical value). - No clinical significance of vital signs, physical examination, laboratory examination, electrocardiogram, ultrasound abdomen and chest X-ray (posterior and anterior) results. Exclusion Criteria: - Positive for Viral hepatitis (including hepatitis B and C), HIV and syphilis. - Those who are known to have allergy history or allergy constitution to the test preparation and any of its components or related preparations. - Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing. - Positive results from urine drug screen test. - Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing. - Subjects who plan to receive or have had organ transplants. - Subjects considered by the investigator to have other factors unsuitable for participation in this study.

Study Design


Related Conditions & MeSH terms

  • Fatty Liver
  • Non-alcoholic Fatty Liver Disease
  • Nonalcoholic Steatohepatitis (NASH)

Intervention

Drug:
HEC96719
Part 2:Mulltiple doses up to 10 days

Locations

Country Name City State
China The Shanghai xuhui district central hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Sunshine Lake Pharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and Tolerability of HEC96719 by Assessment of the Number of Adverse Events To investigate the safety and tolerability of HEC96719 by assessment of AEs (non-serious and serious) following administration of oral solution in MAD up to 17 days
Secondary Cmax Maximum Plasma Concentration(Cmax)of HEC96719 up to 96 hours
Secondary AUC Area Under the Curve(AUC) of HEC96719 up to 96 hours
Secondary Tmax Maximum Peak Time(Tmax) of HEC96719 up to 96 hours
Secondary T1/2 Maximum Peak Time(Tmax) of HEC96719 up to 96 hours
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