NCT07658482尚未招募1 期
A Phase 1, Randomized, Open-label, Parallel-group Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ZL-1503 Following a Single Dose of Subcutaneous or Intravenous Administration in Healthy Volunteers.
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 2
研究概览
简要总结
This is a phase 1, single dose, randomized, open-label, parallel-group study to evaluate the pharmacokinetics (PK), safety, tolerability and immunogenicity of ZL-1503 and to explore its PD biomarkers following a single subcutaneous (SC) or intravenous (IV) administration in healthy volunteers.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female volunteers, 18-65 years of age
- •Body mass index (BMI) between ≥ 18.5 and < 32.5 kg/m2
- •Negative pregnancy tests for women of childbearing potential.
排除标准
- •Significant health issues, such as positive tests for human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg), active tuberculosis, immunodeficiencies or autoimmune diseases.
- •History of major metabolic, liver, kidney, hematologic or other significant disorders.
- •Abnormal Electrocardiogram (ECG) findings
- •Clinically relevant abnormal lab results, including low blood counts, or abnormal liver and kidney function.
- •History of drug abuse or addiction within 6 months prior to screening
- •Current smoker or use of any nicotine or tobacco containing products within the last 6 months prior to dosing.
- •Donated >500mL blood within 2 months of dosing.
研究组 & 干预措施
ZL-1503 (Intravenous Administration)
Experimental
干预措施: ZL-1503 (Drug)
ZL-1503 (Subcutaneous Dose2)
Experimental
干预措施: ZL-1503 (Drug)
ZL-1503 (Subcutaneous Dose 1)
Experimental
干预措施: ZL-1503 (Drug)
研究者
研究点 (2)
Loading locations...
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