Status:
COMPLETED
A Study of LP-168 in Healthy Volunteers
Lead Sponsor:
Guangzhou Lupeng Pharmaceutical Company LTD.
Conditions:
Multiple Sclerosis
NMO Spectrum Disorder
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 coh...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2022
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05432713
Start Date
May 14 2022
End Date
December 28 2022
Last Update
February 24 2023
Active Locations (1)
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1
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009