A Study of LP-168 in Healthy Volunteers

NCT05432713 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: LP-168-CN102
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Sclerosis; NMO Spectrum Disorder

Outcome Measures

Primary Outcomes (8)

• 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

• 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

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

  Up to 96 hours post 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

• 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 Half-life (t1/2) 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

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

  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

  Up to 48 hours post last dose

Study Arms (2)

LP-168 tablet

EXPERIMENTAL

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.

Drug: LP-168 tablet

LP-168 Placebo tablet

PLACEBO COMPARATOR

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.

Drug: LP-168 Placebo tablet

Interventions

LP-168 tablet DRUG

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

Also known as: NWP-775

LP-168 tablet

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

Also known as: NWP-775 Placebo

LP-168 Placebo tablet

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangzhou Lupeng Pharmaceutical Company LTD.: lead

Study Sites (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Multiple Sclerosis; Neuromyelitis Optica

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Myelitis, Transverse; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Eye Diseases

Study Officials

• Jinliang Chen, PhD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 27, 2022
• Study Start: May 14, 2022
• Primary Completion: November 20, 2022
• Study Completion: December 28, 2022
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)