A Study of LP-128 Capsules in Healthy Subjects

Guangzhou Lupeng Pharmaceutical Company

Status and phase: Active, not recruiting; Phase 1

Conditions: Chronic Hepatitis b

Treatments: Drug: LP-128 capsules; Other: Matching Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05130567

LP-128-CN101

Details and patient eligibility

About

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

Full 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.

Enrollment: 104 estimated 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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104 participants in 4 patient groups, including a placebo group

Single-dose Experimental Group

Experimental group

Description:

LP-128 capsule will be adminstrated one time at doses up to 240mg

Treatment:

Drug: LP-128 capsules

Single-dose Control Group

Placebo Comparator group

Description:

Placebo capsule will be adminstrated one time at doses up to 240mg

Treatment:

Other: Matching Placebo

Multi-dose Experimental Group

Experimental group

Description:

LP-128 capsule will be adminstrated once daily, for up to 14 days

Treatment:

Drug: LP-128 capsules

Multi-dose Control Group

Placebo Comparator group

Description:

Placebo capsule will be adminstrated once daily, for up to 14 days

Treatment:

Other: Matching Placebo