NCT07760077尚未招募1 期
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of Single and Multiple Ascending Doses of QLS1510 Tablets in Healthy Adult Participants
Shanghai Qilu Pharmaceutical Research and Development Center LTD0 个研究点目标入组 90 人开始时间: 2026年8月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 主要终点
- Number of Participants with treatment-emergent adverse events (TEAEs)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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,
- •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:
- •ALT or AST > upper limit of normal (ULN);
- •Total bilirubin > 1.5 ULN (direct bilirubin can be measured in participants with a history of Gilbert's syndrome, and participants can be enrolled into this study if direct bilirubin ≤ ULN),
- •Participants with an estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73 m² at screening/baseline, calculated using the Modification of Diet in Renal Disease (MDRD) formula,
- •Participants with a serious infection (e.g., requiring hospitalization, systemic antibacterial therapy, or opportunistic infections) within 6 months prior to screening, or with a history of chronic or recurrent infectious disease that, in the opinion of the investigator, may preclude safe study participation,
- •Participants who have received a live (attenuated) vaccine within 6 weeks prior to the first dose of IP, or who plan to receive a live (attenuated) vaccine during the study period or within 8 weeks after the last dose of IP,
- •Participants who have participated in clinical trials of another investigational product,
- •Participants who have experienced major trauma,
- •Participants with an acute illness (e.g., nausea, vomiting, fever, or diarrhea) within 1 week prior to the first dose of IP,
- •Pregnant or breastfeeding women or participants with a positive pregnancy test result,
- •Participants who, in the investigator's judgment, may be at increased risk of study-related complications, may interfere with the interpretation of study results, or are otherwise unsuitable for study participation.
研究组 & 干预措施
Single ascending doses of QLS1510 tablet
Experimental
干预措施: QLS1510 Tablets (Drug)
Multiple ascending doses of QLS1510 tablet
Experimental
干预措施: QLS1510 Tablets (Drug)
Single ascending doses of placebo
Placebo Comparator
干预措施: QLS1510 placebo Tablets (Drug)
Multiple ascending doses of placebo
Placebo Comparator
干预措施: QLS1510 placebo Tablets (Drug)
结局指标
主要结局
Number of Participants with treatment-emergent adverse events (TEAEs)
时间窗: Up to Week 4
次要结局
未报告次要终点
研究者
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