A Study of LP-128 Capsules in Healthy Subjects
- Conditions
- Chronic Hepatitis b
- Interventions
- Drug: LP-128 capsulesOther: Matching Placebo
- Registration Number
- NCT05130567
- Lead Sponsor
- Guangzhou Lupeng Pharmaceutical Company LTD.
- Brief 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
- Detailed 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 & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 104
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Multi-dose Experimental Group LP-128 capsules LP-128 capsule will be adminstrated once daily, for up to 14 days Multi-dose Control Group Matching Placebo Placebo capsule will be adminstrated once daily, for up to 14 days Single-dose Control Group Matching Placebo Placebo capsule will be adminstrated one time at doses up to 240mg Single-dose Experimental Group LP-128 capsules LP-128 capsule will be adminstrated one time at doses up to 240mg
- Primary Outcome Measures
Name Time Method Apparent terminal phase half-life (T1/2) of LP-128 Up to 4 and 17 days in Single-dose group and Multi-dose group, respectively Plasma samples were collected at different points for pharmacokinetic analysis
Adverse events of LP-128 Up to 28 days The incidence and severity of adverse events as assessed by NCI CTCAE v5.0.
Maximum observed plasma concentration (Cmax) of LP-128 Up to 4 and 17 days in Single-dose group and Multi-dose group, respectively Plasma samples were collected at different points for pharmacokinetic analysis
Area under the plasma concentration-time curve (AUC) of LP-128 Up to 4 and 17 days in Single-dose group and Multi-dose group, respectively Plasma samples were collected at different points for pharmacokinetic analysis
- Secondary Outcome Measures
Name Time Method Excretion of LP-128 in urine Up to 4 days Urine samples will be collected at different points for pharmacokinetic analysis
Excretion of LP-128 in feces Up to 4 days feces samples will be collected at different points for pharmacokinetic analysis
Trial Locations
- Locations (1)
NanFang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China