NCT07148557进行中（未招募）1 期
A Single-center, Open-label, Phase Ib Clinical Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic Characteristics of LP-003 Injection in Adolescent Subjects Aged 12-18 Years
Longbio Pharma1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2025年10月1日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Adverse Events (AE)
研究概览
简要总结
This is a single-center, open-label, phase Ib clinical study to evaluate the safety, pharmacokinetics and pharmacodynamic characteristics of LP-003 injection in adolescent subjects aged 12-18 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adolescent subjects aged ≥12 years and <18 years, male or female.
- •History of allergic diseases (self-reported is acceptable), including, but not limited to, food allergies, allergic rhinitis, allergic asthma, urticaria, and atopic dermatitis.
- •Agreement to use effective contraception during the study and for 6 months after the end of the study.
- •Subject and parent or legal guardian able to understand and voluntarily sign the informed consent form, and comply with study visits and related procedures.
排除标准
- •Allergic to LP-003 or its excipients.
- •Any serious or uncontrolled chronic disease (e.g., severe arrhythmia, ischemic heart disease, NYHA Class III/IV heart failure, severe pulmonary disease, inadequately controlled asthma, hypertension, diabetes, hypo- or hyperthyroidism) that may affect subject safety as determined by the Investigator.
- •History of severe allergic reactions.
- •Abnormal venous access, venipuncture or subcutaneous injection intolerance, history of needle or blood phobia.
- •Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m² at screening.
- •ALT or AST > ULN and considered clinically significant by the Investigator.
- •Any other abnormal screening test result that, in the Investigator's opinion, could affect subject safety or study assessments.
- •Systemic corticosteroid therapy (intravenous, intramuscular, or oral) within 4 weeks prior to study drug administration.
- •Use of medications known to interact with epinephrine (e.g., β-blockers, ACE inhibitors, tricyclic antidepressants) within 4 weeks prior to administration.
- •Use of biologic products (e.g., omalizumab) within 6 months prior to administration.
- •Receipt vaccines within 14 days before administration or planning vaccination during the study.
- •Participation in other clinical trials within 3 months prior to screening or within 5 half-lives of investigational product discontinuation (whichever is longer).
- •Any other conditions that the Investigator considers subjects unsuitable for participation in the study.
研究组 & 干预措施
Cohort 1: LP-003 Dose 1 (Single)
Experimental
干预措施: LP-003 Dose 1 (Single) (Biological)
Cohort 2 : LP-003 Dose 2 (Single)
Experimental
干预措施: LP-003 Dose 2 (Single) (Biological)
结局指标
主要结局
Adverse Events (AE)
时间窗: Observation for 196 days after administration
Number of subjects with treatment-related Treatment Emergent Adverse Events (TEAEs).
次要结局
- Time to peak concentration (Tmax) of LP-003(Observation for 196 days after administration)
- Maximum concentration (Cmax) of LP-003(Observation for 196 days after administration)
- Elimination half-life (t1/2) of LP-003(Observation for 196 days after administration)
- Area under the concentration-time curve (AUC0-t) of LP-003(Observation for 196 days after administration)
- Apparent clearance rate (CL/F) of LP-003(Observation for 196 days after administration)
- Assessment of total immunoglobulin E (IgE)(Observation for 196 days after administration)
- Assessment of free immunoglobulin E (IgE)(Observation for 196 days after administration)
- Assessment of immunogenicity(Observation for 196 days after administration)
研究者
研究点 (1)
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