A Study of LP-168 in Healthy Volunteers
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
We could not find results for this trial
What it found
We found no results in the registry or in papers.
This trial finished 3 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- LP-168 tablet
Placebo
- LP-168 Placebo tablet
What it measured
Main measures
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
SafetySeverity 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
SafetyPharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration (Cmax) of LP-168
Up to 96 hours post last dose
How the body handles the medicinePK 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
How the body handles the medicinePK As Assessed By Time To Maximum Observed Plasma Concentration (Tmax) of LP-168
Up to 96 hours post last dose
How the body handles the medicinePK As Assessed By Terminal Half-life (t1/2) of LP-168
Up to 96 hours post last dose
MRI lesionsHow the body handles the medicinePK As Assessed By Terminal Vd/F of LP-168
Up to 96 hours post last dose
How the body handles the medicinePK As Assessed By Terminal CL/F of LP-168
Up to 96 hours post last dose
How the body handles the medicine
Other measures (1)
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
Who could take part
MS (type not specified) · 18 to 55
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This is a Phase I study designed to assess the safety, tolerability and pharmacokinetics of LP-168 in healthy human volunteers.
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History
Started
May 2022
Main results due
Nov 2022
Finished
Dec 2022