The Tolerability and Pharmacokinetics Study of HEC110114 Tablets in Healthy Adult Subjects

Chronic Hepatitis C Clinical Trial

— HEC110114  

Official title:

A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single & Multiple Ascending Dose Study to Access the Tolerability and Pharmacokinetics of HEC110114 Tablets in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03903081
• Other study ID #: HEC110114-P-01
• Status: Completed
• Phase: Phase 1
• Start date: March 6, 2019
• Est. completion date: October 29, 2019

Study information

• Verified date: April 2019
• Source: Sunshine Lake Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single & Multiple Ascending Dose Study to Access the Tolerability and Pharmacokinetics of HEC110114 Tablets in Healthy Adult Subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: October 29, 2019
• Est. primary completion date: October 29, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions

• Be able to complete the study according to the trail protocol

• Subjects (including partners) have no pregnancy plan within six months after the last dose of study drug and voluntarily take effective contraceptive measures

• Male subjects and must be 18 to 45 years of age inclusive

• Body weight = 50 kg and body mass index(BMI)between 18 and 28 kg/m2, inclusive

• Physical examination and vital signs without clinically significant abnormalities.

Exclusion Criteria:

• Use of >5 cigarettes per day during the past 3 months

• Allergies constitution ( multiple drug and food allergies)

• History of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits or 100 mL of wine)

• Donation or loss of blood over 450 mL within 3 months prior to screening

• 12-lead ECG with clinically significant

• Positive for Viral hepatitis (including hepatitis B and C), HIV and syphilis

• Subjects deemed unsuitable by the investigator for any other reason.

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• HEC110114 tablet
administered orally once daily
• Placebo Oral Tablet
Placebo will be administered orally at a dose and frequency matched to HEC110114

Locations

Country	Name	City	State
China	The First Hospital of Jilin University	Changchun	Jilin

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	Adverse Events	Percentage of Participants with Adverse Events	From Days 1-12
Secondary	Cmax	Maximum Observed Plasma Concentration	At pre-defined intervals from Days 1-12
Secondary	Tmax	Time to Maximum Observed Plasma Concentration	At pre-defined intervals from Days 1-12
Secondary	AUClast	Area Under the Plasma Concentration vs Time Curve to Last Measurable Concentration	At pre-defined intervals from Days 1-12
Secondary	AUC0-8	Area Under the Plasma Concentration vs Time Curve Extrapolated to Infinity	At pre-defined intervals from Days 1-12
Secondary	T1/2	Apparent Half-Life	At pre-defined intervals from Days 1-12
Secondary	CL/F	Clearance (CL/F) of HEC110114	At pre-defined intervals from Days 1-12
Secondary	Cmin	Trough Plasma Concentration of HEC110114	At pre-defined intervals from Days 1-11 for MAD