Multiple Dose Safety, Tolerability, PK，PD and Food Effect Study of HEC96719 in Healthy Adult Subjects
NCT ID: NCT04546984
Last Updated: 2021-05-07
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
66 participants
INTERVENTIONAL
2020-09-14
2020-12-29
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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Single dose of HEC96719 （Part 1，Fed/Fasting）
Following an overnight fast of at least 10 hours, a single dose of HEC96719 will be administered on 2 separate occasions (fasting and after meal) in a randomized crossover fashion with different food restrictions.
HEC96719
Part 2：Mulltiple doses up to 10 days
Mulltiple doses HEC96719（ Part 2, Cohort 1）
Healthy subjects receive multiple doses of HEC96719 or matching placebo
HEC96719
Part 2：Mulltiple doses up to 10 days
Mulltiple doses HEC96719（ Part 2, Cohort 2）
Healthy subjects receive multiple doses of HEC96719 or matching placebo
HEC96719
Part 2：Mulltiple doses up to 10 days
Mulltiple doses HEC96719（ Part 2, Cohort 3）
Healthy subjects receive multiple doses of HEC96719 or matching placebo
HEC96719
Part 2：Mulltiple doses up to 10 days
Mulltiple doses HEC96719（ Part 2, Cohort 4）
Healthy subjects receive multiple doses of HEC96719 or matching placebo
HEC96719
Part 2：Mulltiple doses up to 10 days
Mulltiple doses HEC96719（ Part 2, Cohort 5）
Healthy subjects receive multiple doses of HEC96719 or matching placebo
HEC96719
Part 2：Mulltiple doses up to 10 days
Interventions
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HEC96719
Part 2：Mulltiple doses up to 10 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
45 Years
ALL
Yes
Sponsors
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Sunshine Lake Pharma Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The Shanghai xuhui district central hospital
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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HEC96719-P-02/CRC-C2028
Identifier Type: -
Identifier Source: org_study_id
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