A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of QLS2319 for Injection/Placebo Following Single-Dose Administration in Healthy Subjects and Multiple-Dose Administration in Subjects With Cancer Cachexia.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Phase Ia：Safety and tolerability after a single subcutaneous injection of QLS2319/placebo
研究概览
简要总结
Study To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of QLS2319 in Healthy Subjects and Cancer Cachexia
详细描述
This study is a first-in-human, dose-escalation trial in healthy adult participants and cancer cachexia to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of QLS2319.
The target population of dose escalation part is healthy adult participants, and the dose expansion part will enroll patients with cancer cachexia.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects aged 18-55 years (inclusive), at the time of signing the ICF.;
- •Body weight ≥ 50 kg for males and ≥ 45 kg for females, with a body mass index (BMI = weight (kg)/height 2 (m) 2) of 18.5-26 kg/m2 (inclusive);
- •Participants (including their partners) who have no plan to become pregnant and voluntarily use effective contraception from screening to 6 months after the last dose;
- •Subjects aged ≥ 18 years at screening;
- •Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures;
- •ECOG performance status score of 0, 1;
- •Cancer cachexia documented in medical records; -
排除标准
- •Subjects with clinically significant abnormal laboratory findings, or with clinically significant diseases or conditions, who are considered by the investigator to be ineligible for enrollment in this study.
- •History of HIV infection, syphilis, hepatitis B, or hepatitis C;
- •History of recurrent infections or active infections；
- •Subjects who, in the judgment of the investigator, are not suitable for participation in the study.
- •Current active reversible causes of decreased food intake
- •Cachexia caused by other reasons
- •Receiving tube feedings or parenteral nutrition within 28 days prior to the first administration of the investigational product
- •Presence of concomitant conditions, other than neoplastic cachexia, which are deemed by the investigator to cause difficulty in oral intake or malabsorption of ingested food.
- •Subjects with known allergy to QLS2319 or any of its components, or with a history of severe allergic reactions or uncontrolled allergic asthma.
结局指标
主要结局
Phase Ia：Safety and tolerability after a single subcutaneous injection of QLS2319/placebo
时间窗: Up to Day 99
Incidence and severity of adverse events (AEs), assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 6.0 (v6.0)
Phase Ib：Safety and tolerability after multiple subcutaneous injections of QLS2319
时间窗: Up to 12 weeks
Incidence and severity of adverse events (AEs), assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 6.0 (v6.0)
次要结局
未报告次要终点