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Completed

NCT Number: NCT05432713

A Study of LP-168 in Healthy Volunteers

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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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Cranial Nerve Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Eye Diseases Immune System Diseases Myelitis, Transverse NMO Spectrum Disorder Nervous System Diseases Neuromyelitis Optica Optic Nerve Diseases Optic Neuritis

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LP-168 tablet

Drug

Lp-168 is a small molecule kinase inhibitor that is administered once daily via oral administration

Other names: NWP-775

LP-168 Placebo tablet

Drug

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: NWP-775 Placebo

Primary outcomes

  1. 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

  2. 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

  3. Pharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration (Cmax) of LP-168

    Time frame: Up to 96 hours post last dose

  4. 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

  5. PK As Assessed By Time To Maximum Observed Plasma Concentration (Tmax) of LP-168

    Time frame: Up to 96 hours post last dose

  6. PK As Assessed By Terminal Half-life (t1/2) of LP-168

    Time frame: Up to 96 hours post last dose

  7. PK As Assessed By Terminal Vd/F of LP-168

    Time frame: Up to 96 hours post last dose

  8. PK As Assessed By Terminal CL/F of LP-168

    Time frame: Up to 96 hours post last dose

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Guangzhou Lupeng Pharmaceutical Company LTD.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 27, 2022
Registry last updated
Feb 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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