A Study of LP-168 in Healthy Volunteers

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05432713
• Other study ID #: LP-168-CN102
• Status: Completed
• Phase: Phase 1
• Start date: May 14, 2022
• Est. completion date: December 28, 2022

Study information

• Verified date: February 2023
• Source: Guangzhou Lupeng Pharmaceutical Company LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 28, 2022
• Est. primary completion date: November 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Neuromyelitis Optica
• NMO Spectrum Disorder

Intervention

Drug:
• LP-168 tablet
Lp-168 is a small molecule kinase inhibitor that is administered once daily via oral administration
• 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

Locations

Country	Name	City	State
China	The Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Lupeng Pharmaceutical Company LTD.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment Emergent Adverse Events as determined by CTCAE v5.0		From the first dose of the study drug to 5 days after last dose
Primary	Severity of Treatment Emergent Adverse Events as determined by CTCAE v5.0		From the first dose of the study drug to 5 days after last dose
Primary	Pharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration (Cmax) of LP-168		Up to 96 hours post last dose
Primary	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		Up to 96 hours post last dose
Primary	PK As Assessed By Time To Maximum Observed Plasma Concentration (Tmax) of LP-168		Up to 96 hours post last dose
Primary	PK As Assessed By Terminal Half-life (t1/2) of LP-168		Up to 96 hours post last dose
Primary	PK As Assessed By Terminal Vd/F of LP-168		Up to 96 hours post last dose
Primary	PK As Assessed By Terminal CL/F of LP-168		Up to 96 hours post last dose
Secondary	PD as Assessed by elisa analysis the proportion of LP-168 occupied kinase at scheduled timepoints pre-dose and post-dose		Up to 48 hours post last dose