NCT07443059
招募中
1 期
A Phase I Clinical Study to Evaluate the Pharmacokinetic Characteristics and Safety of Single-dose of Zovaglutide (ZT002 Injection) in Participants With Different Degrees of Renal Insufficiency and Matched Participants With Normal Renal Function
Beijing QL Biopharmaceutical Co.,Ltd3 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年4月13日最近更新:
概览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Beijing QL Biopharmaceutical Co.,Ltd
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Incidence and severity of adverse events
概览
简要总结
This study is a single-dose, open-label, parallel design phase I clinical study to evaluate the PK characteristics and safety of single subcutaneous injection of ZT002 Injection in participants with different degrees of renal insufficiency and matched participants with normal renal function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent;
- •Male or female, age between 18 - 75 years (both inclusive) at the time of signing of the informed consent.
- •Body mass index (BMI) 19.0 - 32.0 kg/m²(both inclusive). Body weight ≥50 kg for male participants and ≥45 kg for female participants.
- •Diagnosed as stable, chronic renal disease for at least 3 months.
- •Renal function, assessed by estimated glomerular filtration rate at screening (eGFR):
- •Normal renal function: 90-129 mL/min (inclusive); Mild impairment: 60-89 mL/min (inclusive); Moderate impairment: 30-59 mL/min (inclusive); Severe impairment: 15-29 mL/min (inclusive);
- •Stable renal function, assessed by two eGFR during screening.
排除标准
- •All participants will not be included in this study if they meet any of the following criteria:
- •History of acute or chronic pancreatitis, or pancreatic injury.
- •History of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine neoplasia (MEN2) in personal or family history.
- •History of depression/anxiety disorder, or prior diagnosis of moderate-to-severe anxiety/depressive state, or history of severe psychiatric disorders;
- •Those with any type of treated or untreated malignancy (whether cured or not) within 5 years before screening or during the baseline period (except basal cell carcinoma of the skin)
- •Those with any type of malignant tumors within 5 years prior to screening (except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix).
- •Participants in the renal insufficiency group will not be included in this study if they meet any of the following criteria:
- •Those with obstructive uropathy (e.g., urinary tract obstruction due to calculi or space-occupying lesions) or renal impairment caused by other etiologies unrelated to intrinsic renal dysfunction (e.g., renal tumors) and/or renal diseases (e.g., renal artery stenosis, nephrotoxic drugs, severe infections, hypovolemia, heart failure, etc.), and deemed by the investigator as unsuitable for participation in this clinical trial.
- •Those with systolic blood pressure exceeding 160 mmHg or diastolic blood pressure exceeding 100 mmHg in the screening period;
- •Those who have received any medications known to alter renal tubular creatinine secretion (e.g., cimetidine, trimethoprim, or cibenzoline, or salicylates excluding topical formulations), competitive inhibitors of renal tubular secretion (e.g., probenecid), or nephrotoxic drugs (e.g., non-steroidal anti-inflammatory drugs, polymyxins, vancomycin) within 14 days prior to screening or 5 half-lives (whichever is longer).
研究组 & 干预措施
D group (Healthy Control)
Experimental
干预措施: Zovaglutide (Drug)
A group (Mild Renal Impairment)
Experimental
干预措施: Zovaglutide (Drug)
B group (Moderate Renal Impairment)
Experimental
干预措施: Zovaglutide (Drug)
C group (Severe Renal Impairment)
Experimental
干预措施: Zovaglutide (Drug)
结局指标
主要结局
Incidence and severity of adverse events
时间窗: Screening period up to Day 50
Time to maximum concentration (Tmax)
时间窗: From baseline to Day 50
Area Under the Concentration Versus Time Curve (AUC) of ZT002 From Time Zero to Tlast (AUC0-t).
时间窗: Start of Treatment up to Day 50
Maximum Concentration of ZT002 (Cmax)
时间窗: Start of Treatment up to Day 50
Area Under the Concentration Versus Time Curve (AUC) of ZT002 From Time Zero to Infinity (AUC0-∞)
时间窗: Start of Treatment up to Day 50
Apparent terminal half-life (t1/2)
时间窗: From baseline to Day 50
Apparent clearance (CL/F)
时间窗: From baseline to Day 50
次要结局
未报告次要终点
研究者
研究点 (3)
Loading locations...
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