Phase I Study of QLS1510 Tablets in Healthy Participants (NCT07760077) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Phase I Study of QLS1510 Tablets in Healthy Participants
90 participantsStarted 2026-08-30
Plain-language summary
This is a Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QLS1510 in Healthy participants
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male and female adults aged between 18 and 45 years, inclusive, at the time of informed consent,
. Medically healthy with no clinically significant or relevant abnormalities in medical history, physical exam, vital signs, ECG, or laboratory evaluations as assessed by the Investigator,
. Body weight ≥50 kg for males and ≥45 kg for females with a body mass index (BMI) between 18.0 and 26.0 kg/m2,
. Participants (including their partners) confirm they have no plans to donate sperm or egg, undergo in vitro fertilization (IVF), or become pregnant, and they agree to use highly effective contraceptive methods.
. Understand and comply with the study procedures and methods, voluntarily participate in the trial, and provide written informed consent.
Exclusion criteria
. Participants with any disease identified at screening that warrants exclusion in the Investigator's judgment,
. Participants with a history of severe allergic reactions (e.g., angioedema or anaphylactic shock), atopic diathesis (e.g., pollen allergy, allergy to two or more drugs or foods), and/or known hypersensitivity to the IP or any of its components,
. Participants with functional asplenia, history of splenectomy, or prior exposure to immunosuppressive therapies or agents, or any other condition that, in the investigator's judgment, compromises immune function,
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with treatment-emergent adverse events (TEAEs)
Timeframe: Up to Week 4
Trial details
NCT IDNCT07760077
SponsorShanghai Qilu Pharmaceutical Research and Development Center LTD
. Participants with positive test results for hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody (HBcAb) and detectable hepatitis B virus deoxyribonucleic acid (HBV-DNA), or positive hepatitis C virus antibody (HCVAb), Treponema pallidum-specific antibody, or human immunodeficiency virus (HIV) antibody during the screening period,
. Participants with a 12-lead ECG at screening/baseline showing QTcF (QT corrected per Fridericia's formula) \> 450 msec for males and \> 470 msec for females,
. Participants with supine systolic blood pressure ≥140 mmHg or \<90 mmHg or diastolic blood pressure ≥90 mmHg or \<60 mmHg after resting in the supine position for at least 5 minutes at screening/baseline,
. Participants with pulse or heart rate (HR) \> 100 or \< 50 bpm after at least 5 minutes of rest at screening/baseline,
. Participants with any of the following laboratory abnormalities at screening/baseline: