Open-Label, Single Dose, Parallel Group, Phase 1 Study in Healthy Volunteers Evaluating Safety, Tolerability, Pharmacokinetics, and Immunogenicity AIO-001 Administered by Injections
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
This goal of the open-label single dose study is to evaluate and compare the safety, tolerability, pharmacokinetic (PK), and immunogenicity of AIO-001 using two different formulations in 16 healthy volunteers.
详细描述
This is an open-label single dose, parallel group, 24-week, Phase 1 study in 16 healthy participants.
The study is designed to evaluate and compare the safety, tolerability, PK, and immunogenicity of AIO-001 using two different formulations (Formulation A and Formulation B) in 16 healthy volunteers (8 receiving each formulation).
The study will include a screening visit from Day -28 to Day -2. Eligible participants will be admitted to the clinical site on Day -1 and will be confined until completion of the assessments on Day 3. Participants will return to the clinical site for outpatient visits for study assessments and laboratory tests.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to understand the study procedures and provide signed informed consent to participate in the study.
- •Male or female.
- •Non-smokers. Light smokers (no more than 5 cigarettes daily [approximately 50 to 60 mg of nicotine per day], or products with equivalent amount of nicotine within 3 months prior to screening) may be permitted.
- •≥18 and ≤55 years of age.
- •BMI >18.5 and <32.0 kg/m2 and body weight ≥45.0 kg.
- •Healthy participants.
排除标准
- •Any clinically significant abnormal finding at physical examination at screening.
- •Clinically significant abnormal laboratory test results or positive serology test results for hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen and antibody, or QuantiFERON®-TB tuberculosis (TB) test at screening.
- •Positive pregnancy test or lactating female participant.
- •Positive urine drug screen or alcohol breath test.
- •History of anaphylaxis, or severe allergy.
- •Previous exposure to thymic stromal lymphopoietin antibody.
研究组 & 干预措施
AIO-001 (Formulation A)
400 milligram (mg) of 100 milligrams per milliliter (mg/ml) AIO-001 Subcutaneous (SC) injection will be administered.
干预措施: AIO-001 (Drug)
AIO-001 (Formulation B)
400 mg of 182 mg/ml AIO-001 SC injection will be administered.
干预措施: AIO-001 (Drug)
结局指标
主要结局
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
时间窗: From Day 1 up to Day 169
An AE was defined as any untoward medical occurrence in a participant or clinical trial participant administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. TEAEs were defined as AEs that commence on or after the time of study drug administration.
Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram Parameters
时间窗: Baseline (Day -1) up to Day 169
The electrocardiogram parameters included heart rate, PR interval, QT interval, corrected QT (QTcF using Fridericia's formula) interval and QRS. The clinically significant changes were based on investigator's judgement.
Number of Participants With Clinically Significant Changes in Vital Signs
时间窗: Baseline (Day -1) up to Day 169
Vital sign measurements included blood pressure, heart rate, respiratory rate, and oral temperature measurements. The clinically significant changes were based on investigator's judgement.
Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters
时间窗: Baseline (Day -1) up to Day 169
Clinical laboratory parameters included biochemistry, hematology, and urinalysis assessment. The clinically significant changes were based on investigator's judgement.
Number of Participants With Clinically Significant Changes in Physical Examination Findings
时间窗: Baseline (Day -1) up to Day 169
Physical examination included assessments of the following: head, eyes, ears, nose, throat, neck, chest, lungs, abdomen, musculoskeletal, dermatological, cardiovascular/peripheral vascular, and general neurological examination. The clinically significant changes were based on investigator's judgement.
次要结局
- Maximal Observed Concentration (Cmax) of AIO-001(Pre-dose, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360, and 4056 hours post-dose)
- Time to Maximal Observed Concentration (Tmax) of AIO-001(Pre-dose, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360, and 4056 hours post-dose)
- Terminal Elimination Half-life (T½) of AIO-001(Pre-dose, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360, and 4056 hours post-dose)
- Area Under the Concentration-time Curve From Time Zero Until the Last Observed Concentration (AUC0-last) of AIO-001(Pre-dose, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360, and 4056 hours post-dose)
- Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of AIO-001(Pre-dose, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360, and 4056 hours post-dose)
- Number of Participants With Positive Anti-drug Antibody (ADA) to AIO-001(Up to Day 169)