NCT06311734CompletedPhase 1
A Study of LW231 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Volunteers and Participants With Chronic Hepatitis B Virus Infection
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
Source: ClinicalTrials.gov · Last updated 15 Oct 2024
Brief summary (registry, in English)
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 .
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 119 (actual)
- First submitted
- 8 Mar 2024
- Start date
- 21 Jun 2022
- Primary completion date
- 1 Jan 2024
- Lead sponsor
- Shanghai Longwood Biopharmaceuticals Co., Ltd.
- Diseases
- Hepatitis B
- NCT number
- NCT06311734
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 119
- From 21 Jun 2022 to the primary completion date, 1 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Lab values
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.