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
70 participants
INTERVENTIONAL
2022-05-14
2022-12-28
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
DOUBLE
Study Groups
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LP-168 tablet
After confirmation of inclusion, subjects will be randomized into the LP-168 tablet or LP-168 placebo tablet arm and receive single or multiple doses of LP-168 tablet or LP-168 placebo tablet.
LP-168 tablet
Lp-168 is a small molecule kinase inhibitor that is administered once daily via oral administration
LP-168 Placebo tablet
After confirmation of inclusion, subjects will be randomized into the LP-168 tablet or LP-168 placebo tablet arm and receive single or multiple doses of LP-168 tablet or LP-168 placebo tablet.
LP-168 Placebo tablet
LP-168 placebo tablets contain excipients for LP-168 tablets, but do not contain the active ingredients of the drug, and are used for comparison in clinical trials with the same usage and dosage as LP-168 tablets
Interventions
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LP-168 tablet
Lp-168 is a small molecule kinase inhibitor that is administered once daily via oral administration
LP-168 Placebo tablet
LP-168 placebo tablets contain excipients for LP-168 tablets, but do not contain the active ingredients of the drug, and are used for comparison in clinical trials with the same usage and dosage as LP-168 tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects (including partners) are willing to take effective contraception measures during study and within 3 months after last dose
* Male and female healthy subjects aged 18 to 55 years old
* Male subjects weigh ≥ 50 kg, and female subjects weigh ≥ 45 kg
* Subjects able to understand and comply with study requirements
* Willing to sign the informed consent
Exclusion Criteria
* Abnormal ECG or echocardiography with clinical significance
* Hepatitis B virus, Hepatitis C virus, HIV and syphilis test positive. COVID-19 DNA positive.
* Subjects who have taken any drugs or health care products within 14 or 28 days before administration the study drug
* Subjects who have consumed diets that may alter the activity of liver metabolic enzymes within 7 days before administration the study drug
* Subjects who have consumed tea or alcohol-containing food product within 24hrs before administration the study drug
* Subjects who have a history of dysphagia or condition may affect drug absorption, distribution, metabolism and excretion
* Female subjects are breastfeeding or pregnant
* Subjects who have a history of drug/ alcohol/ tobacco abuse
* Subjects who have had a blood donation or massive blood loss within three months before screening; or had surgery within six months before screening
* Subjects who have participated in other clinical trial within three months before screening
* Subjects have special dietary requirements or cannot tolerate a standard meal
18 Years
55 Years
ALL
Yes
Sponsors
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Guangzhou Lupeng Pharmaceutical Company LTD.
INDUSTRY
Responsible Party
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Principal Investigators
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Jinliang Chen, PhD
Role: PRINCIPAL_INVESTIGATOR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Locations
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The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Other Identifiers
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LP-168-CN102
Identifier Type: -
Identifier Source: org_study_id
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