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A Study of LP-128 Capsules in Healthy Subjects

Primary Purpose

Chronic Hepatitis b

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
LP-128 capsules
Matching Placebo
Sponsored by
Guangzhou Lupeng Pharmaceutical Company LTD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis b

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • NanFang Hospital of Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Single-dose Experimental Group

Single-dose Control Group

Multi-dose Experimental Group

Multi-dose Control Group

Arm Description

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

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

LP-128 capsule will be adminstrated once daily, for up to 14 days

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

Outcomes

Primary Outcome Measures

Area under the plasma concentration-time curve (AUC) of LP-128
Plasma samples were collected at different points for pharmacokinetic analysis
Apparent terminal phase half-life (T1/2) of LP-128
Plasma samples were collected at different points for pharmacokinetic analysis
Maximum observed plasma concentration (Cmax) of LP-128
Plasma samples were collected at different points for pharmacokinetic analysis
Adverse events of LP-128
The incidence and severity of adverse events as assessed by NCI CTCAE v5.0.

Secondary Outcome Measures

Excretion of LP-128 in urine
Urine samples will be collected at different points for pharmacokinetic analysis
Excretion of LP-128 in feces
feces samples will be collected at different points for pharmacokinetic analysis

Full Information

First Posted
November 9, 2021
Last Updated
September 8, 2023
Sponsor
Guangzhou Lupeng Pharmaceutical Company LTD.
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1. Study Identification

Unique Protocol Identification Number
NCT05130567
Brief Title
A Study of LP-128 Capsules in Healthy Subjects
Official Title
A Randomized Study of LP-128 Capsules vs. Placebo to Evaluate Safety, Tolerability and Pharmacokinetics in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 19, 2021 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangzhou Lupeng Pharmaceutical Company LTD.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis b

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single-dose Experimental Group
Arm Type
Experimental
Arm Description
LP-128 capsule will be adminstrated one time at doses up to 240mg
Arm Title
Single-dose Control Group
Arm Type
Placebo Comparator
Arm Description
Placebo capsule will be adminstrated one time at doses up to 240mg
Arm Title
Multi-dose Experimental Group
Arm Type
Experimental
Arm Description
LP-128 capsule will be adminstrated once daily, for up to 14 days
Arm Title
Multi-dose Control Group
Arm Type
Placebo Comparator
Arm Description
Placebo capsule will be adminstrated once daily, for up to 14 days
Intervention Type
Drug
Intervention Name(s)
LP-128 capsules
Other Intervention Name(s)
NWP-1080
Intervention Description
Oral dosing with LP-128 capsules
Intervention Type
Other
Intervention Name(s)
Matching Placebo
Intervention Description
Oral dosing with placebo capsules to match LP-128 capsules.
Primary Outcome Measure Information:
Title
Area under the plasma concentration-time curve (AUC) of LP-128
Description
Plasma samples were collected at different points for pharmacokinetic analysis
Time Frame
Up to 4 and 17 days in Single-dose group and Multi-dose group, respectively
Title
Apparent terminal phase half-life (T1/2) of LP-128
Description
Plasma samples were collected at different points for pharmacokinetic analysis
Time Frame
Up to 4 and 17 days in Single-dose group and Multi-dose group, respectively
Title
Maximum observed plasma concentration (Cmax) of LP-128
Description
Plasma samples were collected at different points for pharmacokinetic analysis
Time Frame
Up to 4 and 17 days in Single-dose group and Multi-dose group, respectively
Title
Adverse events of LP-128
Description
The incidence and severity of adverse events as assessed by NCI CTCAE v5.0.
Time Frame
Up to 28 days
Secondary Outcome Measure Information:
Title
Excretion of LP-128 in urine
Description
Urine samples will be collected at different points for pharmacokinetic analysis
Time Frame
Up to 4 days
Title
Excretion of LP-128 in feces
Description
feces samples will be collected at different points for pharmacokinetic analysis
Time Frame
Up to 4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yue Shen, Ph.D
Phone
86571-81999616
Email
yshen@lupengbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chongyuan Xu, MD, PhD
Organizational Affiliation
Nanfang Hospital of Nanfang Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
NanFang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chongyuan Xu, MD, PhD
Phone
020-62787926
Email
nfyygcp@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

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A Study of LP-128 Capsules in Healthy Subjects

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