The Tolerability and Pharmacokinetics Study of HEC110114 Tablets in Healthy Adult Subjects
Phase 1
Completed
- Conditions
- Chronic Hepatitis C
- Interventions
- Drug: HEC110114 tabletDrug: Placebo Oral Tablet
- Registration Number
- NCT03903081
- Lead Sponsor
- Sunshine Lake Pharma Co., Ltd.
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 93
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1000 mg single dose Placebo Oral Tablet Healthy subjects, receiving a single dose of 1000 mg HEC110114 tablet (N=8) or matching placebo (N=2) 600 mg single dose HEC110114 tablet Healthy subjects, receiving a single dose of 600 mg HEC110114 tablet (N=8) or matching placebo (N=2) 100 mg single dose Placebo Oral Tablet It includes two groups, one group is pilot study, healthy subjects receive a single dose of 100 mg HEC110114 tablet (N=2) . Another group is formal study, healthy subjects receive a single dose of 100 mg HEC110114 tablet (N=8) or matching placebo (N=2) 300 mg single dose Placebo Oral Tablet Healthy subjects, receiving a single dose of 300 mg HEC110114 tablet (N=8) or matching placebo (N=2) 600 mg single dose Placebo Oral Tablet Healthy subjects, receiving a single dose of 600 mg HEC110114 tablet (N=8) or matching placebo (N=2) 1000 mg single dose HEC110114 tablet Healthy subjects, receiving a single dose of 1000 mg HEC110114 tablet (N=8) or matching placebo (N=2) 1200 mg single dose Placebo Oral Tablet Healthy subjects, receiving a single dose of 1200 mg HEC110114 tablet (N=8) or matching placebo (N=2) 1600 mg single dose HEC110114 tablet Healthy subjects, receiving a single dose of 1600 mg HEC110114 tablet (N=8) or matching placebo (N=2) 1000 mg multiple doses Placebo Oral Tablet Healthy subjects, receiving 1000 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days 100 mg single dose HEC110114 tablet It includes two groups, one group is pilot study, healthy subjects receive a single dose of 100 mg HEC110114 tablet (N=2) . Another group is formal study, healthy subjects receive a single dose of 100 mg HEC110114 tablet (N=8) or matching placebo (N=2) 800 mg single dose HEC110114 tablet Healthy subjects, receiving a single dose of 800 mg HEC110114 tablet (N=16) or matching placebo (N=2) under fed or fasted conditions, this group is a two-sequence, two-period crossover study 800 mg single dose Placebo Oral Tablet Healthy subjects, receiving a single dose of 800 mg HEC110114 tablet (N=16) or matching placebo (N=2) under fed or fasted conditions, this group is a two-sequence, two-period crossover study 1200 mg single dose HEC110114 tablet Healthy subjects, receiving a single dose of 1200 mg HEC110114 tablet (N=8) or matching placebo (N=2) 600 mg multiple doses Placebo Oral Tablet Healthy subjects, receiving 600 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days 800 mg multiple doses Placebo Oral Tablet Healthy subjects, receiving 800 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days 300 mg single dose HEC110114 tablet Healthy subjects, receiving a single dose of 300 mg HEC110114 tablet (N=8) or matching placebo (N=2) 600 mg multiple doses HEC110114 tablet Healthy subjects, receiving 600 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days 800 mg multiple doses HEC110114 tablet Healthy subjects, receiving 800 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days 1000 mg multiple doses HEC110114 tablet Healthy subjects, receiving 1000 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days 1600 mg single dose Placebo Oral Tablet Healthy subjects, receiving a single dose of 1600 mg HEC110114 tablet (N=8) or matching placebo (N=2)
- Primary Outcome Measures
Name Time Method Adverse Events From Days 1-12 Percentage of Participants with Adverse Events
- Secondary Outcome Measures
Name Time Method Tmax At pre-defined intervals from Days 1-12 Time to Maximum Observed Plasma Concentration
CL/F At pre-defined intervals from Days 1-12 Clearance (CL/F) of HEC110114
Cmax At pre-defined intervals from Days 1-12 Maximum Observed Plasma Concentration
Cmin At pre-defined intervals from Days 1-11 for MAD Trough Plasma Concentration of HEC110114
AUC0-∞ At pre-defined intervals from Days 1-12 Area Under the Plasma Concentration vs Time Curve Extrapolated to Infinity
AUClast At pre-defined intervals from Days 1-12 Area Under the Plasma Concentration vs Time Curve to Last Measurable Concentration
T1/2 At pre-defined intervals from Days 1-12 Apparent Half-Life
Trial Locations
- Locations (1)
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China