Chronic Hepatitis BPhase 1NCT06311734
A Study of LW231 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Volunteers and Participants With Chronic Hepatitis B Virus Infection
A Phase 1 study testing LW231 tablets in people with Chronic Hepatitis B, run by Shanghai Longwood Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
To Evaluate the Tolerability and Pharmacokinetics of LW231 Tablets in Single-center, Randomized, Double-blind, Placebo-controlled Multiple-dose, Single-dose, Multiple-dose Phase Ia Clinical Trials 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?
- LW231 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 1 siteChina
- Study dates
- 21 Jun 2022to 18 Mar 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- 1.18-55 years old male or female. 2.Body Mass Index (BMI) between 18 to 28 kg/m2 (inclusive) and body weight equal to or over 45 kg for females and 50kg for males.
- 3.Healthy status will be defined as the absence of evidence of any active or chronic disease following a detailed medical and surgical history, concomitant drug use (including hormonal supplements), a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology, and urinalysis.
Who cannot join
- Any clinically significant abnormalities in laboratory test results at screening. In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility.
- Participants who have donated over 450 mL of blood or blood products or had significant blood loss within three months prior to screening.
- Heavy smokers (those who smoke greater than or equal to 5 or more cigarettes a day within three months prior to screening).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Randomized, Double-blind,Placebo-controlled Study, to Evaluate Safety,Tolerability, Pharmacokinetics and Pharmacodynamics of LW231 in Healthy Volunteers and Patients With Chronic Hepatitis B Virus Infection
To Evaluate the Tolerability and Pharmacokinetics of LW231 Tablets in Single-center, Randomized, Double-blind, Placebo-controlled Multiple-dose, Single-dose, Multiple-dose Phase Ia Clinical Trials in Healthy Subjects .
Read the detailed description
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of LW231 tablets in healthy volunteers and in chronic hepatitis B (CHB) patients after single and multiple doses. In addition, the study will evaluate the initial antiviral efficacy of LW231 in CHB patients following a multiple dosing regimen.
- Conditions
- Chronic Hepatitis B
- Being tested
- LW231 tablets, 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.
LW231 tabletsDrug
Also called LW231
P.O.
PlaceboDrug
P.O.
| Study group | Role | What they receive |
|---|---|---|
| Part A: SAD in healthy participants | Experimental | Part A: Single ascending doses of up to 800 mg LW231 tablets in healthy participants. Receives: Drug: LW231 tablets; Drug: Placebo |
| Part b: MAD in healthy participants | Experimental | Part B: Multiple ascending doses of up to 400 mg LW231 tablets in healthy participants. Dosages will be determined from data collected from Part A. Receives: Drug: LW231 tablets; Drug: Placebo |
| Part c: MAD in CHB participants (optional) | Experimental | Part C: Multiple ascending doses of up to 400 mg LW231 tablets in CHB participants. Dosages will be determined from data collected from Part A and Part B. Receives: Drug: LW231 tablets; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs)
An adverse event (AE) was defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product (including investigational drug) during the course of a clinical investigation. An AE could therefore be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease that was temporally associated with the use of the investigational product, regardless of whether it was considered to be related to the investigational product or not.
Measured: Up to 4 days for SAD, up to 3 days after the last dose of study drug for MAD
Secondary outcomes (5)
Maximum Plasma Concentration (Cmax) of LW231
Measured: Up to 4 days after the last dose of study drug
Time to Cmax (Tmax) of LW231
Measured: Up to 4 days after the last dose of study drug
Area Under the Curve From Time 0 to the Last Measurable Concentration (AUClast) of LW231
Measured: Up to 4 days after the last dose of study drug
Area Under the Curve From Time 0 to 24 Hours (AUC0-24) of LW231
Measured: Up to 4 days after the last dose of study drug
Half-life (t1/2) of LW231
Measured: Up to 4 days after the last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start21 Jun 2022
- Primary completion1 Jan 2024
- Study completion18 Mar 2024
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.
- 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Longwood Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06311734
- Sponsor's protocol ID
- LW231-I-01
- Status last verified
- Sep 2023
- First submitted
- 8 Mar 2024
- Last updated
- 15 Oct 2024
- Results posted
- 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 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Double-blind,Placebo-controlled Study, to Evaluate Safety,Tolerability, Pharmacokinetics and Pharmacodynamics of LW231 in Healthy Volunteers and Patients With Chronic Hepatitis B Virus Infection
- ClinicalTrials.gov ID
- NCT06311734
- Acronym / sponsor ID
- LW231-I-01
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Shanghai Longwood Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 18 Mar 2024 (actual)
- First posted
- 15 Mar 2024 (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.
To Evaluate the Tolerability and Pharmacokinetics of LW231 Tablets in Single-center, Randomized, Double-blind, Placebo-controlled Multiple-dose, Single-dose, Multiple-dose Phase Ia Clinical Trials in Healthy Subjects .
Detailed description
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of LW231 tablets in healthy volunteers and in chronic hepatitis B (CHB) patients after single and multiple doses. In addition, the study will evaluate the initial antiviral efficacy of LW231 in CHB patients following a multiple dosing regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A: SAD in healthy participants | Experimental | Drug: LW231 tablets, Drug: PlaceboPart A: Single ascending doses of up to 800 mg LW231 tablets in healthy participants. |
| Part b: MAD in healthy participants | Experimental | Drug: LW231 tablets, Drug: PlaceboPart B: Multiple ascending doses of up to 400 mg LW231 tablets in healthy participants. Dosages will be determined from data collected from Part A. |
| Part c: MAD in CHB participants (optional) | Experimental | Drug: LW231 tablets, Drug: PlaceboPart C: Multiple ascending doses of up to 400 mg LW231 tablets in CHB participants. Dosages will be determined from data collected from Part A and Part B. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 1.18-55 years old male or female. 2.Body Mass Index (BMI) between 18 to 28 kg/m2 (inclusive) and body weight equal to or over 45 kg for females and 50kg for males.
- 3.Healthy status will be defined as the absence of evidence of any active or chronic disease following a detailed medical and surgical history, concomitant drug use (including hormonal supplements), a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology, and urinalysis.
Key exclusion criteria (3 listed)
- Any clinically significant abnormalities in laboratory test results at screening. In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility.
- Participants who have donated over 450 mL of blood or blood products or had significant blood loss within three months prior to screening.
- Heavy smokers (those who smoke greater than or equal to 5 or more cigarettes a day within three months prior to screening).
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 |
|---|---|---|
| LW231 tabletsAlso: LW231P.O. | Drug | Part A: SAD in healthy participants, Part b: MAD in healthy participants, Part c: MAD in CHB participants (optional) |
| PlaceboP.O. | Drug | Part A: SAD in healthy participants, Part b: MAD in healthy participants, Part c: MAD in CHB participants (optional) |
Primary outcome
Number of Participants With Adverse Events (AEs)
Time frame: Up to 4 days for SAD, up to 3 days after the last dose of study drug for MAD
An adverse event (AE) was defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product (including investigational drug) during the course of a clinical investigation. An AE could therefore be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease that was temporally associated with the use of the investigational product, regardless of whether it was considered to be related to the investigational product or not.
5 secondary outcomes
Maximum Plasma Concentration (Cmax) of LW231
Time frame: Up to 4 days after the last dose of study drug
Time to Cmax (Tmax) of LW231
Time frame: Up to 4 days after the last dose of study drug
Area Under the Curve From Time 0 to the Last Measurable Concentration (AUClast) of LW231
Time frame: Up to 4 days after the last dose of study drug
Area Under the Curve From Time 0 to 24 Hours (AUC0-24) of LW231
Time frame: Up to 4 days after the last dose of study drug
Half-life (t1/2) of LW231
Time frame: Up to 4 days after the last dose of study drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 LW231 tablets in people with Chronic Hepatitis B, run by Shanghai Longwood Biopharmaceuticals Co., 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 15 Oct 2024. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Participants With Adverse Events (AEs) (time frame: Up to 4 days for SAD, up to 3 days after the last dose of study drug for MAD). 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 15 Oct 2024.