Back to resultsA Study of LP-168 in Healthy Volunteers
Primary Purpose
Multiple Sclerosis, NMO Spectrum Disorder
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
LP-168 tablet
LP-168 Placebo tablet
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis
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
Exclusion Criteria:
- Abnormal vital signs, physical examination or laboratory tests with clinical significance
- Abnormal ECG or echocardiography with clinical significance
- Hepatitis B virus, Hepatitis C virus, HIV and syphilis test positive. COVID-19 DNA positive.
- Subjects who have taken any drugs or health care products within 14 or 28 days before administration the study drug
- Subjects who have consumed diets that may alter the activity of liver metabolic enzymes within 7 days before administration the study drug
- 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 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
Sites / Locations
- The Second Affiliated Hospital Zhejiang University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
LP-168 tablet
LP-168 Placebo tablet
Arm Description
After confirmation of inclusion, subjects will be randomized into the LP-168 tablet or LP-168 placebo tablet arm and receive single or multiple doses of LP-168 tablet or LP-168 placebo tablet.
After confirmation of inclusion, subjects will be randomized into the LP-168 tablet or LP-168 placebo tablet arm and receive single or multiple doses of LP-168 tablet or LP-168 placebo tablet.
Outcomes
Primary Outcome Measures
Number of Participants With Treatment Emergent Adverse Events as determined by CTCAE v5.0
Severity of Treatment Emergent Adverse Events as determined by CTCAE v5.0
Pharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration (Cmax) of LP-168
PK As Assessed By Area Under The Plasma Concentration Time Curve From Time 0 To The Time of The Last Quantifiable Concentration (AUC0-t) Of LP-168
PK As Assessed By Time To Maximum Observed Plasma Concentration (Tmax) of LP-168
PK As Assessed By Terminal Half-life (t1/2) of LP-168
PK As Assessed By Terminal Vd/F of LP-168
PK As Assessed By Terminal CL/F of LP-168
Secondary Outcome Measures
PD as Assessed by elisa analysis the proportion of LP-168 occupied kinase at scheduled timepoints pre-dose and post-dose
Full Information
NCT ID
NCT05432713
First Posted
June 14, 2022
Last Updated
February 22, 2023
Sponsor
Guangzhou Lupeng Pharmaceutical Company LTD.
1. Study Identification
Unique Protocol Identification Number
NCT05432713
Brief Title
A Study of LP-168 in Healthy Volunteers
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LP-168 Following Single and Multiple Oral Administration to Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 14, 2022 (Actual)
Primary Completion Date
November 20, 2022 (Actual)
Study Completion Date
December 28, 2022 (Actual)
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
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a Phase I study designed to assess the safety, tolerability and pharmacokinetics of LP-168 in healthy human volunteers.
Detailed Description
This study will enroll 70 healthy subjects, will set 4 SAD and 3 MAD dose cohorts, with 10 subjects in each dose cohort. Subjects will be assigned to L-168 or placebo group by ratio of 8:2 in each cohort. Sentinel subjects will be used in each dose cohort during the single dose phase.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, NMO Spectrum Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LP-168 tablet
Arm Type
Experimental
Arm Description
After confirmation of inclusion, subjects will be randomized into the LP-168 tablet or LP-168 placebo tablet arm and receive single or multiple doses of LP-168 tablet or LP-168 placebo tablet.
Arm Title
LP-168 Placebo tablet
Arm Type
Placebo Comparator
Arm Description
After confirmation of inclusion, subjects will be randomized into the LP-168 tablet or LP-168 placebo tablet arm and receive single or multiple doses of LP-168 tablet or LP-168 placebo tablet.
Intervention Type
Drug
Intervention Name(s)
LP-168 tablet
Other Intervention Name(s)
NWP-775
Intervention Description
Lp-168 is a small molecule kinase inhibitor that is administered once daily via oral administration
Intervention Type
Drug
Intervention Name(s)
LP-168 Placebo tablet
Other Intervention Name(s)
NWP-775 Placebo
Intervention Description
LP-168 placebo tablets contain excipients for LP-168 tablets, but do not contain the active ingredients of the drug, and are used for comparison in clinical trials with the same usage and dosage as LP-168 tablets
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events as determined by CTCAE v5.0
Time Frame
From the first dose of the study drug to 5 days after last dose
Title
Severity of Treatment Emergent Adverse Events as determined by CTCAE v5.0
Time Frame
From the first dose of the study drug to 5 days after last dose
Title
Pharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration (Cmax) of LP-168
Time Frame
Up to 96 hours post last dose
Title
PK As Assessed By Area Under The Plasma Concentration Time Curve From Time 0 To The Time of The Last Quantifiable Concentration (AUC0-t) Of LP-168
Time Frame
Up to 96 hours post last dose
Title
PK As Assessed By Time To Maximum Observed Plasma Concentration (Tmax) of LP-168
Time Frame
Up to 96 hours post last dose
Title
PK As Assessed By Terminal Half-life (t1/2) of LP-168
Time Frame
Up to 96 hours post last dose
Title
PK As Assessed By Terminal Vd/F of LP-168
Time Frame
Up to 96 hours post last dose
Title
PK As Assessed By Terminal CL/F of LP-168
Time Frame
Up to 96 hours post last dose
Secondary Outcome Measure Information:
Title
PD as Assessed by elisa analysis the proportion of LP-168 occupied kinase at scheduled timepoints pre-dose and post-dose
Time Frame
Up to 48 hours post last dose
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
Exclusion Criteria:
Abnormal vital signs, physical examination or laboratory tests with clinical significance
Abnormal ECG or echocardiography with clinical significance
Hepatitis B virus, Hepatitis C virus, HIV and syphilis test positive. COVID-19 DNA positive.
Subjects who have taken any drugs or health care products within 14 or 28 days before administration the study drug
Subjects who have consumed diets that may alter the activity of liver metabolic enzymes within 7 days before administration the study drug
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinliang Chen, PhD
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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A Study of LP-168 in Healthy Volunteers
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