NCT07231679招募中1 期
A Randomized, Placebo-Controlled, Multicenter, Phase 1/2a Study to Investigate the Safety, Tolerability, and Pharmacokinetics of IGT-303 in Healthy Volunteers and Participants With Chronic Kidney Disease
Ingenia Therapeutics INC6 个研究点 分布在 2 个国家目标入组 94 人开始时间: 2025年10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
- 招募中
- 发起方
- 入组人数
- 94
- 试验地点
- 6
- 主要终点
- Adverse events (AEs), serious adverse events (SAEs), and treatment-emergent adverse events (TEAEs)
研究概览
简要总结
The goal of this clinical trial is to observe the safety of IGT-303 in healthy volunteers and participants with Chronic Kidney Disease. The main question it aims to answer is:
Is IGT-303 safe as a single dose or multiple dose regimen when applied under the skin (subcutaneously (SC)) or to a vein (intravenously (IV)).
Researchers will compare IGT-303 against a placebo to see if IGT-303 is safe for use.
Participants will be assigned to either IGT-303 or placebo and assessed for safety and tolerability for the duration of the study.
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
- Double (Participant, Investigator)
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
- •Participant 18-75 years of age, inclusive, at Screening;
- •Able to understand the key components of the study as described in the written informed consent document, and willing and able to provide written informed consent;
- •Body mass index (BMI) within the range of 18.5 to 40 kg/m2 at Screening;
- •Have a diagnosis of chronic kidney disease stage 2-3b, resulting from Type 2 diabetic nephropathy;
- •UACR >30 mg/g, <5000 mg/g at Screening and Day -1;
- •If taking antihypertensive and/or antidiabetic medication, doses of medications must be stable for at least 90 days prior to Screening;
- •Participants assigned male at birth (AMAB) will be either sterile or agree to use an approved method of contraception from Screening until at least 5 half-lives plus 90 days after the last dose of study drug, or do not engage in sexual relations which carry a risk of pregnancy (does include abstinence), and agree to refrain from sperm donation and in vitro fertilization until 5 half-lives plus 90 days after the last dose of the study drug; Participants assigned female at birth (AFAB) must be of non-childbearing potential or agree to use two highly effective methods of conception from Screening until at least 5 half-lives plus 30 days after the last dose of study drug or do not engage in sexual relations which carry a risk of pregnancy (does include abstinence), and agree to refrain from egg donation and in vitro fertilization until 5 half-lives plus 30 days after the last dose of the study drug
- •In the opinion of the Investigator, is able to adhere to the requirements of the study, including required overnight stays in the research site;
- •For participants in Cohort 9 only, have a diagnosis of nonproliferative diabetic retinopathy
排除标准
- •Known allergy to study medication or its components (non-medicinal ingredients) or a history of a severe allergic reaction to any drug or history of multiple food/drug allergies;
- •Use of cigarettes exceeding >5 cigarettes per week at time of Screening; social/casual cigarette use (≤5 per week) is permitted during the study, but participants must be willing to abstain during inpatient confinement;
- •Positive urine screen for drugs of abuse including tetrahydrocannabinol or has a positive breathalyzer test, at Screening or at Day -1;
- •Any illness or medical history that would impact safety or compliance with study requirements or impact ability to interpret study data
- •For participants in Cohort 9 only, presence of diabetic macular edema with anti-vascular endothelial growth factor (VEGF) treatment or vitreous hemorrhage.
研究组 & 干预措施
IGT-303
Experimental
Part A: single ascending dose (SAD), 6 cohorts Part B: multiple ascending dose (MAD), 3 cohorts
干预措施: IGT-303 (Drug)
Placebo
Placebo Comparator
Placebo (normal saline)
干预措施: Placebo (Drug)
结局指标
主要结局
Adverse events (AEs), serious adverse events (SAEs), and treatment-emergent adverse events (TEAEs)
时间窗: From Screening to Day 84.
The number and severity (by Grade) will be measured.
次要结局
- PK Parameters of IV and SC IGT-303(Day 1 to Day 84)
- PK parameters of IV and SC IGT-303(Day 1 to Day 84)
- PK Parameters of Intravenous (IV) and Subcutaneous (SC) IGT-303(Day 1 to Day 84.)
研究者
研究点 (6)
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