The Tolerability and Pharmacokinetics Study of HEC110114 Tablets in Healthy Adult Subjects
NCT ID: NCT03903081
Last Updated: 2020-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
93 participants
INTERVENTIONAL
2019-03-06
2019-10-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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100 mg single dose
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)
HEC110114 tablet
administered orally once daily
Placebo Oral Tablet
Placebo will be administered orally at a dose and frequency matched to HEC110114
300 mg single dose
Healthy subjects, receiving a single dose of 300 mg HEC110114 tablet (N=8) or matching placebo (N=2)
HEC110114 tablet
administered orally once daily
Placebo Oral Tablet
Placebo will be administered orally at a dose and frequency matched to HEC110114
600 mg single dose
Healthy subjects, receiving a single dose of 600 mg HEC110114 tablet (N=8) or matching placebo (N=2)
HEC110114 tablet
administered orally once daily
Placebo Oral Tablet
Placebo will be administered orally at a dose and frequency matched to HEC110114
800 mg single dose
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
HEC110114 tablet
administered orally once daily
Placebo Oral Tablet
Placebo will be administered orally at a dose and frequency matched to HEC110114
1000 mg single dose
Healthy subjects, receiving a single dose of 1000 mg HEC110114 tablet (N=8) or matching placebo (N=2)
HEC110114 tablet
administered orally once daily
Placebo Oral Tablet
Placebo will be administered orally at a dose and frequency matched to HEC110114
1200 mg single dose
Healthy subjects, receiving a single dose of 1200 mg HEC110114 tablet (N=8) or matching placebo (N=2)
HEC110114 tablet
administered orally once daily
Placebo Oral Tablet
Placebo will be administered orally at a dose and frequency matched to HEC110114
1600 mg single dose
Healthy subjects, receiving a single dose of 1600 mg HEC110114 tablet (N=8) or matching placebo (N=2)
HEC110114 tablet
administered orally once daily
Placebo Oral Tablet
Placebo will be administered orally at a dose and frequency matched to HEC110114
600 mg multiple doses
Healthy subjects, receiving 600 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days
HEC110114 tablet
administered orally once daily
Placebo Oral Tablet
Placebo will be administered orally at a dose and frequency matched to HEC110114
800 mg multiple doses
Healthy subjects, receiving 800 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days
HEC110114 tablet
administered orally once daily
Placebo Oral Tablet
Placebo will be administered orally at a dose and frequency matched to HEC110114
1000 mg multiple doses
Healthy subjects, receiving 1000 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days
HEC110114 tablet
administered orally once daily
Placebo Oral Tablet
Placebo will be administered orally at a dose and frequency matched to HEC110114
Interventions
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HEC110114 tablet
administered orally once daily
Placebo Oral Tablet
Placebo will be administered orally at a dose and frequency matched to HEC110114
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
45 Years
ALL
Yes
Sponsors
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Sunshine Lake Pharma Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yanhua Ding, Doctor
Role: PRINCIPAL_INVESTIGATOR
The First Hospital of Jilin University
Locations
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The First Hospital of Jilin University
Changchun, Jilin, China
Countries
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Other Identifiers
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HEC110114-P-01
Identifier Type: -
Identifier Source: org_study_id
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