A Study of LP-128 Capsules in Healthy Subjects

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Hepatitis b
• Intervention / Treatment: Drug: LP-128 capsules; Other: Matching Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Nanfang Hospital of Southern Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Guangzhou Lupeng Pharmaceutical Company LTD.
• Investigators: Principal Investigator: Chongyuan Xu, MD, PhD, Nanfang Hospital of Nanfang Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2021
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: November 9, 2021
• First Submitted That Met QC Criteria: November 21, 2021
• First Posted (Actual): November 23, 2021

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Disease Attributes; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Chronic; Hepatitis; Chronic Disease; Hepatitis B; Hepatitis B, Chronic
• Other Study ID Numbers: LP-128-CN101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No