Clinical trial NCT05432713: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Sclerosis
NMO Spectrum Disorder
Lead sponsor: Guangzhou Lupeng Pharmaceutical Company LTD.
Sponsor class: INDUSTRY
First posted: 2022-06-27
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events as determined by CTCAE v5.0
timeFrame: From the first dose of the study drug to 5 days after last dose
measure: Severity of Treatment Emergent Adverse Events as determined by CTCAE v5.0
timeFrame: From the first dose of the study drug to 5 days after last dose
measure: Pharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration (Cmax) of LP-168
timeFrame: Up to 96 hours post last dose
measure: 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
timeFrame: Up to 96 hours post last dose
measure: PK As Assessed By Time To Maximum Observed Plasma Concentration (Tmax) of LP-168
timeFrame: Up to 96 hours post last dose
measure: PK As Assessed By Terminal Half-life (t1/2) of LP-168
timeFrame: Up to 96 hours post last dose
measure: PK As Assessed By Terminal Vd/F of LP-168
timeFrame: Up to 96 hours post last dose
measure: PK As Assessed By Terminal CL/F of LP-168
timeFrame: Up to 96 hours post last dose
Secondary outcomes:
measure: PD as Assessed by elisa analysis the proportion of LP-168 occupied kinase at scheduled timepoints pre-dose and post-dose
timeFrame: Up to 48 hours post last dose
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Jinliang Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References: