Clinical trial NCT05130567: A Study of LP-128 Capsules in Healthy Subjects
Official title: A Randomized Study of LP-128 Capsules vs. Placebo to Evaluate Safety, Tolerability and Pharmacokinetics in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Chronic Hepatitis b
Lead sponsor: Guangzhou Lupeng Pharmaceutical Company LTD.
Sponsor class: INDUSTRY
First posted: 2021-11-23
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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 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

Primary outcomes:
measure: Area under the plasma concentration-time curve (AUC) of LP-128
timeFrame: Up to 4 and 17 days in Single-dose group and Multi-dose group, respectively
measure: Apparent terminal phase half-life (T1/2) of LP-128
timeFrame: Up to 4 and 17 days in Single-dose group and Multi-dose group, respectively
measure: Maximum observed plasma concentration (Cmax) of LP-128
timeFrame: Up to 4 and 17 days in Single-dose group and Multi-dose group, respectively
measure: Adverse events of LP-128
timeFrame: Up to 28 days
Secondary outcomes:
measure: Excretion of LP-128 in urine
timeFrame: Up to 4 days
measure: Excretion of LP-128 in feces
timeFrame: Up to 4 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: NanFang Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital of Nanfang Medical University
name: Chongyuan Xu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: