A Study of LP-168 in Healthy Volunteers

Launched by GUANGZHOU LUPENG PHARMACEUTICAL COMPANY LTD. · Jun 20, 2022

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility 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