A Study of LP-128 Capsules in Healthy Subjects

NCT05130567 | Active Not Recruiting Phase 1

• 1 other identifier: LP-128-CN101
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Hepatitis b

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• Adverse events of LP-128

  The incidence and severity of adverse events as assessed by NCI CTCAE v5.0.

  Up to 28 days

Secondary Outcomes (2)

• Excretion of LP-128 in urine

  Up to 4 days

• Excretion of LP-128 in feces

  Up to 4 days

Study Arms (4)

Single-dose Experimental Group

EXPERIMENTAL

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

Drug: LP-128 capsules

Single-dose Control Group

PLACEBO COMPARATOR

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

Other: Matching Placebo

Multi-dose Experimental Group

EXPERIMENTAL

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

Drug: LP-128 capsules

Multi-dose Control Group

PLACEBO COMPARATOR

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

Other: Matching Placebo

Interventions

LP-128 capsules DRUG

Oral dosing with LP-128 capsules

Also known as: NWP-1080

Multi-dose Experimental Group; Single-dose Experimental Group

Matching Placebo OTHER

Oral dosing with placebo capsules to match LP-128 capsules.

Multi-dose Control Group; Single-dose Control Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangzhou Lupeng Pharmaceutical Company LTD.: lead

Study Sites (1)

NanFang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chongyuan Xu, MD, PhD

  Nanfang Hospital of Nanfang Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: November 23, 2021
• Study Start: November 19, 2021
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)