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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ACTIVE_NOT_RECRUITING
PHASE1
104 participants
INTERVENTIONAL
2021-11-19
2026-12-30
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 Experimental Group
LP-128 capsule will be adminstrated one time at doses up to 240mg
LP-128 capsules
Oral dosing with LP-128 capsules
Single-dose Control Group
Placebo capsule will be adminstrated one time at doses up to 240mg
Matching Placebo
Oral dosing with placebo capsules to match LP-128 capsules.
Multi-dose Experimental Group
LP-128 capsule will be adminstrated once daily, for up to 14 days
LP-128 capsules
Oral dosing with LP-128 capsules
Multi-dose Control Group
Placebo capsule will be adminstrated once daily, for up to 14 days
Matching Placebo
Oral dosing with placebo capsules to match LP-128 capsules.
Interventions
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LP-128 capsules
Oral dosing with LP-128 capsules
Matching Placebo
Oral dosing with placebo capsules to match LP-128 capsules.
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 and fully understand the content, process and possible adverse reactions of the trial
Exclusion Criteria
* Abnormal ECG, chest X-ray, abdominal ultrasound or echocardiography with clinical significance
* Positive screening for viral hepatitis, HIV and syphilis
* Subjects who have taken any drugs or health care products within 14 or 28 days before administration the study drug; or 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 major 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
* Subjects who are not suitable for this trial based on the assessment of investigator
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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Chongyuan Xu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Nanfang Hospital of Nanfang Medical University
Locations
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NanFang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Countries
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Other Identifiers
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LP-128-CN101
Identifier Type: -
Identifier Source: org_study_id
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