A Study of LP-168 in Healthy Volunteers

Phase 1

Completed

• Conditions: Multiple Sclerosis; NMO Spectrum Disorder
• Interventions: Drug: LP-168 Placebo tablet; Drug: LP-168 tablet

• Registration Number: NCT05432713
• Lead Sponsor: Guangzhou Lupeng Pharmaceutical Company LTD.

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.

Study Timeline

• Study Start: 2022-05-14
• Study First Submitted: 2022-06-14
• Study First Submitted QC: 2022-06-20
• Study First Posted: 2022-06-27
• Primary Completion: 2022-11-20
• Study Completion: 2022-12-28
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-22
• Last Update Posted: 2023-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LP-168 Placebo tablet	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 tablet	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.

Primary Outcome Measures

Name	Time	Method
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
PK As Assessed By Time To Maximum Observed Plasma Concentration (Tmax) of LP-168	Up to 96 hours post last dose
PK As Assessed By Terminal Vd/F of LP-168	Up to 96 hours post last dose
Pharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration (Cmax) of LP-168	Up to 96 hours post last dose
PK As Assessed By Terminal Half-life (t1/2) of LP-168	Up to 96 hours post last dose
PK As Assessed By Terminal CL/F of LP-168	Up to 96 hours post last dose
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
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The Second Affiliated Hospital Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China