- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05432713
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
Status
Completed
Conditions
Intervention / Treatment
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
- Name: Jinliang Chen, PhD
- Phone Number: 8657187783759
- Email: chenjinliang@zju.edu.cn
Study Locations
-
-
Zhejiang
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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:
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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:
|
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
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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
Additional Relevant MeSH Terms
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Eye Diseases
- Optic Nerve Diseases
- Cranial Nerve Diseases
- Myelitis, Transverse
- Optic Neuritis
- Multiple Sclerosis
- Neuromyelitis Optica
Other Study ID Numbers
- LP-168-CN102
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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