A Study of LP-128 Capsules in Healthy Subjects

Study Overview
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Brief Summary
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A Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of LP-128 Capsules After Single- and Multiple-Dose in Healthy Subjects

Detailed Description
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This trial includes single dose and multiple dose phases. The single-dose phase included six dose cohorts. Based on the safety and pharmacokinetic results of single-dose study, approximately 2 doses will be selected to conduct multiple-dose study. The primary study objectives are to evaluate the safety, tolerability, and pharmacokinetic characteristics of LP-128 capsules in healthy subjects after single and multiple dosing.

Official Title
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A Randomized Study of LP-128 Capsules vs. Placebo to Evaluate Safety, Tolerability and Pharmacokinetics in Healthy Subjects

Conditions
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Chronic Hepatitis b

Intervention / Treatment
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* Drug: LP-128 capsules
* Other: Matching Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects have no history of serious digestive system, central nervous system, cardiovascular system, kidney, respiratory system, metabolism and endocrine, skeletal and muscular system, blood system disease and cancer 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 vital signs, physical examination or laboratory tests with clinical significance 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single-dose Experimental Group<br>LP-128 capsule will be adminstrated one time at doses up to 240mg | Drug: LP-128 capsules<br>* Oral dosing with LP-128 capsules<br>* Other names: NWP-1080;|
| Placebo Comparator: Single-dose Control Group<br>Placebo capsule will be adminstrated one time at doses up to 240mg | Other: Matching Placebo<br>* Oral dosing with placebo capsules to match LP-128 capsules.<br>|
| Experimental: Multi-dose Experimental Group<br>LP-128 capsule will be adminstrated once daily, for up to 14 days | Drug: LP-128 capsules<br>* Oral dosing with LP-128 capsules<br>* Other names: NWP-1080;|
| Placebo Comparator: Multi-dose Control Group<br>Placebo capsule will be adminstrated once daily, for up to 14 days | Other: Matching Placebo<br>* Oral dosing with placebo capsules to match LP-128 capsules.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration-time curve (AUC) of LP-128 | Plasma samples were collected at different points for pharmacokinetic analysis | Up to 4 and 17 days in Single-dose group and Multi-dose group, respectively | 
| Apparent terminal phase half-life (T1/2) of LP-128 | Plasma samples were collected at different points for pharmacokinetic analysis | Up to 4 and 17 days in Single-dose group and Multi-dose group, respectively | 
| Maximum observed plasma concentration (Cmax) of LP-128 | Plasma samples were collected at different points for pharmacokinetic analysis | Up to 4 and 17 days in Single-dose group and Multi-dose group, respectively | 
| Adverse events of LP-128 | The incidence and severity of adverse events as assessed by NCI CTCAE v5.0. | Up to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Excretion of LP-128 in urine | Urine samples will be collected at different points for pharmacokinetic analysis | Up to 4 days | 
| Excretion of LP-128 in feces | feces samples will be collected at different points for pharmacokinetic analysis | Up to 4 days |