A Study of LP-128 Capsules in Healthy Subjects

Chronic Hepatitis b Clinical Trial

Official title:

A Randomized Study of LP-128 Capsules vs. Placebo to Evaluate Safety, Tolerability and Pharmacokinetics in Healthy Subjects

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05130567
• Other study ID #: LP-128-CN101
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: November 19, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2024
• Source: Guangzhou Lupeng Pharmaceutical Company LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of LP-128 Capsules After Single- and Multiple-Dose in Healthy Subjects

Description:

This trial includes single dose and multiple dose phases. The single-dose phase included six dose cohorts. Based on the safety and pharmacokinetic results of single-dose study, approximately 2 doses will be selected to conduct multiple-dose study. The primary study objectives are to evaluate the safety, tolerability, and pharmacokinetic characteristics of LP-128 capsules in healthy subjects after single and multiple dosing.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 104
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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 and fully understand the content, process and possible adverse reactions of the trial

Exclusion Criteria:

• Abnormal vital signs, physical examination or laboratory tests with clinical significance
• Abnormal ECG, chest X-ray, abdominal ultrasound or echocardiography with clinical significance
• Positive screening for viral hepatitis, HIV and syphilis
• Subjects who have taken any drugs or health care products within 14 or 28 days before administration the study drug; or 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
• Subjects who are not suitable for this trial based on the assessment of investigator

Related Conditions & MeSH terms

• Chronic Hepatitis b
• Hepatitis B
• Hepatitis B, Chronic

Intervention

Drug:
• LP-128 capsules
Oral dosing with LP-128 capsules

Other:
• Matching Placebo
Oral dosing with placebo capsules to match LP-128 capsules.

Locations

Country	Name	City	State
China	NanFang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Lupeng Pharmaceutical Company LTD.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration-time curve (AUC) of LP-128	Plasma samples were collected at different points for pharmacokinetic analysis	Up to 4 and 17 days in Single-dose group and Multi-dose group, respectively
Primary	Apparent terminal phase half-life (T1/2) of LP-128	Plasma samples were collected at different points for pharmacokinetic analysis	Up to 4 and 17 days in Single-dose group and Multi-dose group, respectively
Primary	Maximum observed plasma concentration (Cmax) of LP-128	Plasma samples were collected at different points for pharmacokinetic analysis	Up to 4 and 17 days in Single-dose group and Multi-dose group, respectively
Primary	Adverse events of LP-128	The incidence and severity of adverse events as assessed by NCI CTCAE v5.0.	Up to 28 days
Secondary	Excretion of LP-128 in urine	Urine samples will be collected at different points for pharmacokinetic analysis	Up to 4 days
Secondary	Excretion of LP-128 in feces	feces samples will be collected at different points for pharmacokinetic analysis	Up to 4 days