A Randomised, Placebo-Controlled, Double-blind, Single and Multiple Ascending Dose, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics Following Intravenous Administration of IRX-010 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Number of participants with Serious Adverse Events
研究概览
简要总结
The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics with intravenous(IV) administration of IRX-010 in Healthy Participants.
详细描述
This is a single and multiple ascending dose, proof of concept study assessing the safe and tolerable dose of IRX-010 in healthy participants. Approximately 81 healthy participants will be enrolled in up to 9 cohorts. The study is conducted in two parts (part A and part B) with 6 single ascending dose (Part A - SAD) cohorts of 9 participants per cohort and 3 multiple ascending dose (Part B - MAD) cohorts of 9 participants per cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- •Male or Female participants who are healthy as determined by medical history and physical evaluation.
- •Have clinical laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically. significant by the investigator at screening and enrolment.
- •Have an estimated glomerular filtration rate ≥60 mL/minute/1.73 m2 at screening and enrolment.
- •Have venous access sufficient to allow for blood sampling as per the protocol. Weight
- •Have a body mass index of 18.0 to 32.0 kg/m2 inclusive, at screening.
排除标准
- •Have a history or presence of clinically significant medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, haematological, renal, endocrine, psychiatric or neurological disease, or any clinically significant laboratory abnormality that, in the judgment of the investigator, indicates a medical problem that would preclude study participation.
- •Have history (within past 5 years) of, or presence of, uncontrolled asthma, significant rheumatological or autoimmune diseases, including but not limited to systemic lupus erythematosus, RA, Sjogren's Syndrome, or vasculitis; or hereditary angioedema, or common variable immune deficiency.
- •Have had lymphoma, leukaemia, or any malignancy within the past 5 years.
- •Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (if known) (whichever is longer) prior to dosing
- •Have active or latent Tuberculosis (TB), based on a positive medical history, examination, chest x-rays (as per local TB screening guidelines), and/or TB test results.
研究组 & 干预措施
IRX-010 Part A (SAD)
A single dose of IRX-010 will be administered intravenously
干预措施: IRX-010 (Drug)
Placebo Part A (SAD)
Placebo administered intravenously
干预措施: Placebo (Drug)
IRX-010 Part B(MAD)
Multiple doses of IRX-010 will be administered intravenously
干预措施: IRX-010 (Drug)
Placebo Part B(MAD)
Placebo administered intravenously
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with Serious Adverse Events
时间窗: Baseline upto Day 168
Evaluation of Safety and Tolerability of IRX-010
Number of participants with Treatment-Emergent Adverse Events
时间窗: Baseline upto Day 168
Evaluation of Safety and Tolerability of IRX-010
次要结局
- Pharmacokinetics(PK): Half-Life (t½)(Baseline upto Day 168)
- Pharmacokinetics(PK): Maximum Concentration (Cmax)(Baseline upto Day 168)
- Pharmacokinetics(PK): Area under Curve(AUC)(Baseline upto Day 168)