Chronic Hepatitis bPhase 1NCT05130567
A Study of LP-128 Capsules in Healthy Subjects
A Phase 1 study testing LP-128 capsules in people with Chronic Hepatitis b, run by Guangzhou Lupeng Pharmaceutical Company LTD. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis b
- What is being tested?
- LP-128 capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 19 Nov 2021to 30 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
China1 site
NanFang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
About this study
Official title: A Randomized Study of LP-128 Capsules vs. Placebo to Evaluate Safety, Tolerability and Pharmacokinetics in Healthy Subjects
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
Read the 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.
- Conditions
- Chronic Hepatitis b
- Being tested
- LP-128 capsules, Matching Placebo
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LP-128 capsulesDrug
Also called NWP-1080
Oral dosing with LP-128 capsules
Matching PlaceboOther
Oral dosing with placebo capsules to match LP-128 capsules.
| Study group | Role | What they receive |
|---|---|---|
| Single-dose Experimental Group | Experimental | LP-128 capsule will be adminstrated one time at doses up to 240mg Receives: Drug: LP-128 capsules |
| Single-dose Control Group | Placebo comparator | Placebo capsule will be adminstrated one time at doses up to 240mg Receives: Other: Matching Placebo |
| Multi-dose Experimental Group | Experimental | LP-128 capsule will be adminstrated once daily, for up to 14 days Receives: Drug: LP-128 capsules |
| Multi-dose Control Group | Placebo comparator | Placebo capsule will be adminstrated once daily, for up to 14 days Receives: Other: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve (AUC) of LP-128
Plasma samples were collected at different points for pharmacokinetic analysis
Measured: 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
Measured: 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
Measured: 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.
Measured: Up to 28 days
Secondary outcomes (2)
Excretion of LP-128 in urine
Urine samples will be collected at different points for pharmacokinetic analysis
Measured: Up to 4 days
Excretion of LP-128 in feces
feces samples will be collected at different points for pharmacokinetic analysis
Measured: Up to 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start19 Nov 2021
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis bStudies of the same condition, open and under way.
- More trials run by Guangzhou Lupeng Pharmaceutical Company LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Lupeng Pharmaceutical Company LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chongyuan Xu, MD, PhD, Principal investigator, Nanfang Hospital of Nanfang Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130567
- Sponsor's protocol ID
- LP-128-CN101
- Status last verified
- Mar 2025
- First submitted
- 9 Nov 2021
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of LP-128 Capsules vs. Placebo to Evaluate Safety, Tolerability and Pharmacokinetics in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05130567
- Acronym / sponsor ID
- LP-128-CN101
- Conditions
- Chronic Hepatitis b
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Guangzhou Lupeng Pharmaceutical Company LTD.Industry (pharma, biotech, devices)
- Study start
- 19 Nov 2021 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 23 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single-dose Experimental Group | Experimental | Drug: LP-128 capsulesLP-128 capsule will be adminstrated one time at doses up to 240mg |
| Single-dose Control Group | Placebo comparator | Other: Matching PlaceboPlacebo capsule will be adminstrated one time at doses up to 240mg |
| Multi-dose Experimental Group | Experimental | Drug: LP-128 capsulesLP-128 capsule will be adminstrated once daily, for up to 14 days |
| Multi-dose Control Group | Placebo comparator | Other: Matching PlaceboPlacebo capsule will be adminstrated once daily, for up to 14 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LP-128 capsulesAlso: NWP-1080Oral dosing with LP-128 capsules | Drug | Multi-dose Experimental Group, Single-dose Experimental Group |
| Matching PlaceboOral dosing with placebo capsules to match LP-128 capsules. | Other | Multi-dose Control Group, Single-dose Control Group |
Primary outcome
Area under the plasma concentration-time curve (AUC) of LP-128
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 28 days
The incidence and severity of adverse events as assessed by NCI CTCAE v5.0.
2 secondary outcomes
Excretion of LP-128 in urine
Time frame: Up to 4 days
Excretion of LP-128 in feces
Time frame: Up to 4 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Chronic Hepatitis b
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chongyuan Xu, MD, PhD principal investigator
Nanfang Hospital of Nanfang Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LP-128 capsules in people with Chronic Hepatitis b, run by Guangzhou Lupeng Pharmaceutical Company LTD. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration-time curve (AUC) of LP-128 (time frame: Up to 4 and 17 days in Single-dose group and Multi-dose group, respectively). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.