A Study of LP-168 in Healthy Volunteers

February 22, 2023 updated by: Guangzhou Lupeng Pharmaceutical Company LTD.

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

This is a Phase I study designed to assess the safety, tolerability and pharmacokinetics of LP-168 in healthy human volunteers.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • The Second Affiliated Hospital Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LP-168 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.
Lp-168 is a small molecule kinase inhibitor that is administered once daily via oral administration
Other Names:
  • NWP-775
Placebo Comparator: 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.
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
Other Names:
  • NWP-775 Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From the first dose of the study drug to 5 days after last dose
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
From the first dose of the study drug to 5 days after last dose
Pharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration (Cmax) of LP-168
Time Frame: Up to 96 hours post last dose
Up to 96 hours post last dose
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
Up to 96 hours post last dose
PK As Assessed By Time To Maximum Observed Plasma Concentration (Tmax) of LP-168
Time Frame: Up to 96 hours post last dose
Up to 96 hours post last dose
PK As Assessed By Terminal Half-life (t1/2) of LP-168
Time Frame: Up to 96 hours post last dose
Up to 96 hours post last dose
PK As Assessed By Terminal Vd/F of LP-168
Time Frame: Up to 96 hours post last dose
Up to 96 hours post last dose
PK As Assessed By Terminal CL/F of LP-168
Time Frame: Up to 96 hours post last dose
Up to 96 hours post last dose

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Up to 48 hours post last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jinliang Chen, PhD, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2022

Primary Completion (Actual)

November 20, 2022

Study Completion (Actual)

December 28, 2022

Study Registration Dates

First Submitted

June 14, 2022

First Submitted That Met QC Criteria

June 20, 2022

First Posted (Actual)

June 27, 2022

Study Record Updates

Last Update Posted (Actual)

February 24, 2023

Last Update Submitted That Met QC Criteria

February 22, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

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

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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