NCT05130567Active, not recruitingPhase 1
A Study of LP-128 Capsules in Healthy Subjects
A Randomized Study of LP-128 Capsules vs. Placebo to Evaluate Safety, Tolerability and Pharmacokinetics in Healthy Subjects
Source: ClinicalTrials.gov · Last updated 3 Apr 2025
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 104 (estimated)
- First submitted
- 9 Nov 2021
- Start date
- 19 Nov 2021
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Guangzhou Lupeng Pharmaceutical Company LTD.
- Diseases
- Hepatitis B
- NCT number
- NCT05130567
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 104
- From 19 Nov 2021 to the primary completion date, 30 Sept 2026
- 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
- 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 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
Other illness
- Positive screening for viral hepatitis, HIV and syphilis
- Subjects who have a history of dysphagia or condition may affect drug absorption, distribution, metabolism and excretion
- Subjects who have a history of drug/alcohol/tobacco abuse
Lab values
- Abnormal vital signs, physical examination or laboratory tests with clinical significance
Other
- Abnormal ECG, chest X-ray, abdominal ultrasound or echocardiography with clinical significance
- Female subjects are breastfeeding or pregnant
- 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
Who the study is looking for
- 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
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 |
|---|---|---|---|
| Nanfang Hospital of Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.