A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study With Single Blind Sentinel Period to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IGNX001 in Peanut-Allergic Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Incidence and Severity of Treatment Emergent Adverse Events
研究概览
简要总结
The goal of this randomized, double-blind, placebo-controlled, single ascending dose clinical trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of IGNX001 in peanut-allergic adults and older Adolescents.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
With the exception of the single sentinel participants for each cohort who will be single blinded (participant blinded), the study will be designed as a double-blind study thus the Investigator, site staff (other than pharmacists), sponsor, sponsors delegates (if applicable) and participants are all blinded to treatment.
入排标准
- 年龄范围
- 15 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of physician-diagnosed peanut allergy with clinical reaction to peanut within 2 hours of exposure to peanut or peanut-containing food (within the last 15 years).
- •Peanut specific IgE level ≥ 1 kUA/L.
- •Positive peanut SPT with wheal diameter ≥ 5 mm.
排除标准
- •History of severe or life-threatening anaphylaxis requiring intubation or admission to intensive care unit within 1 year prior to Screening.
- •Current, or within the past year, treatment with food allergen immunotherapy or participation in a food allergy immunotherapy study.
- •Current treatment with aeroallergen immunotherapy, except if on stable monthly maintenance SC aeroallergen immunotherapy.
研究组 & 干预措施
IGNX001
Participants will receive IGNX001 given as a single subcutaneous dose on Day 1.
干预措施: IGNX001 (Drug)
Placebo
Participants will receive IGNX001 placebo given as a single subcutaneous dose on Day 1.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence and Severity of Treatment Emergent Adverse Events
时间窗: From time of dose until Exit Visit/Early Termination Visit or until AE is resolved or no further follow-up is required, whichever is longer (up to 13 weeks).
Treatment emergent adverse events (TEAE) are undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment. All adverse events will be captured and assessed.
Number of Participants with Clinically Significant Changes from Baseline - 12-lead ECGs for HR, PR, QRS, QT, RR and QTcF, and information on T- and U-waves
时间窗: Assessed at Screening, Days 1, 15, and 85 (up to 25 weeks).
All ECGs will be obtained in supine position following a 10-minute rest. Any clinically significant ECG abnormalities will be captured and reported.
Number of Participants with Clinically Significant Changes from Baseline - Physical Examinations
时间窗: Assessed at Screening, Days 1, 2, 4, 8, 15, 29, 43, 57, 71, and 85 (up to 25 weeks).
Complete physical examinations include general appearance, head, ears, eyes, nose, throat, dentition, thyroid, chest (heart, lungs), abdomen, skin, neurological, extremities, back, neck, musculoskeletal, and lymph nodes. Body weight (kilogram) and height (meter) will be obtained with the participant's shoes and jacket or coat removed. Body mass index is calculated by dividing the participant's body weight in kilograms by the participant's height in meters, squared (kg/m2).
Incidence of Serious Adverse Events and Suspected Unexpected Serious Adverse Reactions
时间窗: From consent until Exit Visit/Early Termination Visit or until SAE is resolved or no further follow-up is required, whichever is longer (up to 13 weeks).
A serious adverse events is an adverse event that meets the criteria of being serious as determined by the Investigator. Suspected unexpected serious adverse reactions is an event assessed as serious, related to study product, and unexpected, which are subject to expedited reporting to regulatory authorities and study Investigators.
Number of Participants with Clinically significant Changes from Baseline - Hematology
时间窗: Assessed at Screening, Days 1, 2, 4, 8, 15, 29, 43, 57, 71, and 85 (up to 25 weeks).
The following list of attributes will be assessed: Hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes (white blood cells), differentials (counts): neutrophils, basophils, eosinophils, lymphocytes, and monocytes
Number of Participants with Clinically Significant Changes from Baseline - Chemistry
时间窗: Assessed at Screening, Days 1, 2, 4, 8, 15, 29, 43, 57, 71, and 85 (up to 25 weeks).
The following list of attributes will be assessed: Aspartate aminotransferase, alanine aminotransferase, total and conjugated bilirubin, alkaline phosphatase, gamma-glutamyl-transferase, creatine phosphokinase, albumin, creatinine, blood urea nitrogen, total protein, sodium, chloride, calcium, phosphate, potassium, triglycerides, total cholesterol, glucose.
次要结局
- Concentration of IGNX001 in the Plasma(Assessed at Days 1, 2, 4, 8, 15, 29, 43, 57, 71 and 85 (up to 13 weeks).)
- Measurement of Area under the Plasma/Serum Concentration Curve (AUC)(Assessed at Days 1, 2, 4, 8, 15, 29, 43, 57, 71 and 85 (up to 13 weeks).)
- Peak Serum Concentration (Cmax)(Assessed at Days 1, 2, 4, 8, 15, 29, 43, 57, 71 and 85 (up to 13 weeks).)
- Time to Peak Serum Concentration (Tmax)(Assessed at Days 1, 2, 4, 8, 15, 29, 43, 57, Day 71 and 85 (up to 13 weeks).)
- Elimination Half-life (t1/2)(Assessed at Days 1, 2, 4, 8, 15, 29, 43, 57, 71 and 85 (up to 13 weeks).)
- Changes Over Time to Anti-drug Antibodies(Assessed at Day 1, Day 15, Day 29, Day 57 and 85 (up to 13 weeks).)