A Phase I Study of LP-168 in Healthy Volunteers

• Status: Recruiting
• Trial end date: 2022-11-02
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Guangzhou Lupeng Pharmaceutical Company LTD.

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 major 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