A Study of LP-128 Capsules in Healthy Subjects

NCT ID: NCT05130567

Last Updated: 2025-04-03

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-19

Study Completion Date

2026-12-30

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.

Conditions

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Chronic Hepatitis b

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Single-dose Experimental Group

LP-128 capsule will be adminstrated one time at doses up to 240mg

Group Type EXPERIMENTAL

LP-128 capsules

Intervention Type DRUG

Oral dosing with LP-128 capsules

Single-dose Control Group

Placebo capsule will be adminstrated one time at doses up to 240mg

Group Type PLACEBO_COMPARATOR

Matching Placebo

Intervention Type OTHER

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

Group Type EXPERIMENTAL

LP-128 capsules

Intervention Type DRUG

Oral dosing with LP-128 capsules

Multi-dose Control Group

Placebo capsule will be adminstrated once daily, for up to 14 days

Group Type PLACEBO_COMPARATOR

Matching Placebo

Intervention Type OTHER

Oral dosing with placebo capsules to match LP-128 capsules.

Interventions

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LP-128 capsules

Oral dosing with LP-128 capsules

Intervention Type DRUG

Matching Placebo

Oral dosing with placebo capsules to match LP-128 capsules.

Intervention Type OTHER

Other Intervention Names

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NWP-1080

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Guangzhou Lupeng Pharmaceutical Company LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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China

Other Identifiers

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LP-128-CN101

Identifier Type: -

Identifier Source: org_study_id

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