Chronic Hepatitis b
Conditions
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.
Interventions
DRUGLP-128 capsules
Oral dosing with LP-128 capsules
OTHERMatching Placebo
Oral dosing with placebo capsules to match LP-128 capsules.
Sponsors
Guangzhou Lupeng Pharmaceutical Company LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Adverse events of LP-128 | Up to 28 days | The incidence and severity of adverse events as assessed by NCI CTCAE v5.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Outcome results
None listed