A Study of LP-168 in Healthy Volunteers

Guangzhou Lupeng Pharmaceutical Company

Status and phase: Completed; Phase 1

Conditions: NMO Spectrum Disorder; Multiple Sclerosis

Treatments: Drug: LP-168 Placebo tablet; Drug: LP-168 tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT05432713

LP-168-CN102

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups, including a placebo group

LP-168 tablet

Experimental group

Description:

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.

Treatment:

Drug: LP-168 tablet

LP-168 Placebo tablet

Placebo Comparator group

Description:

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.

Treatment:

Drug: LP-168 Placebo tablet