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临床试验/NCT05476497
NCT05476497进行中（未招募）1 期

A Phase I Clinical Trial to Evaluate the Safety and Tolerability of VLP Peanut in Healthy Subjects and Subjects With Peanut Allergy and to Explore Preliminary Signals of Its Efficacy (PROTECT)

Allergy Therapeutics10 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2022年10月17日最近更新:
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适应症
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
46
试验地点
10
主要终点
Number and severity of Adverse Events (AEs) (including local and systemic AEs).
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This phase I clinical trial is designed to evaluate the safety and tolerability of VLP Peanut in healthy subjects and in subjects with peanut allergy (PA). This clinical trial will evaluate the immunotoxicity profile of VLP Peanut in healthy subjects and assess the immunotoxicity profile and the degree of reactogenicity (allergenicity) in subjects with PA. This clinical trial will also explore preliminary proof of efficacy of VLP Peanut in subjects with PA.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Part A is open label. Part B is double blind, placebo controlled

入排标准

年龄范围
18 Years 至 50 Years（Adult）
性别
All
接受健康志愿者
是

入选标准

  • •Part A Main Inclusion Criteria:
  • •Capable of giving signed informed consent.
  • •Subject who has a signed and dated Informed Consent Form (ICF).
  • •Subject must be 18 to 50 years inclusive, at the time of signing the ICF.
  • •Male or female.
  • •Female subjects who are not of childbearing potential (or females of childbearing potential who agree to comply with the contraceptive requirements of the clinical trial protocol).
  • •Good general health, as determined by the Investigator.
  • •A positive SPT to histamine.
  • •The following additional inclusion criteria are only applicable to the healthy subjects in Group A1:
  • •Healthy subjects (non-atopic) with no clinically significant co-morbidity (including broncho-reactive airway disease like asthma, current allergic rhinitis, etc.).
  • •Subjects with no history of allergy or intolerance to peanut or any other food and who consume peanuts with no effect.
  • •Subjects with lack of sensitivity to peanut allergen confirmed by SPT using whole peanut extract.
  • •Peanut specific immunoglobulin E (IgE) <0.35 kU/L.
  • •Ara h 2 specific IgE <0.35 kU/L.
  • •Subjects with negative basophil activation test (BAT).
  • •The following additional inclusion criteria are only applicable to the subjects with PA in Group A2:
  • •Clinical history of physician diagnosed PA.
  • •Peanut allergen sensitivity confirmed by SPT and IgE.
  • •Subjects who currently adhere to a strict peanut-free diet and who agree to continue this for the duration of the clinical trial.
  • •Subjects who are able to handle and correctly use an adrenaline auto-injector.
  • •Part B Main Inclusion Criteria:
  • •Capable of giving signed informed consent.
  • •Subject who has a signed and dated ICF.
  • •Subjects aged 18 to 50 years of age inclusive, at the time of signing the ICF.
  • •Male or female.
  • •Female subjects who are not of childbearing potential (or females of childbearing potential who agree to comply with the contraceptive requirements of the clinical trial protocol).
  • •Clinical history of physician diagnosed PA.
  • •Peanut allergen sensitivity confirmed by positive SPT and Ara h 2 specific IgE ≥1.0 kU/L
  • •Subjects with positive BAT.
  • •Subjects who currently adhere to a strict peanut-free diet and who agree to continue this for the duration of the clinical trial.
  • •Good general health, as determined by the Investigator.
  • •Subjects who are able to handle and correctly use an adrenaline auto-injector.

排除标准

  • •Part A and B:
  • •Pregnant or lactating subject.
  • •Presence of any medical condition that may reduce the ability to survive a serious allergic reaction.
  • •Subjects with atopic dermatitis with >25% skin surface involvement.
  • •For subjects with PA, presence of severe, poorly controlled or uncontrolled asthma.
  • •History of severe or life-threatening anaphylactic reactions to peanut resulting in neurological compromise or requiring mechanical ventilation.
  • •History of severe or life-threatening anaphylactic reactions to foods (excluding peanuts), insect venom, exercise, drugs, or idiopathic causes, resulting in neurological compromise or requiring mechanical ventilation or deemed severe as per Investigator assessment.
  • •Unable to receive epinephrine therapy or at greater risk of developing adverse reactions after epinephrine administration as assessed by the site Investigator.
  • •Clinical history of drug or alcohol abuse, which, in the Investigator's opinion, could interfere with the subject's ability to participate in the clinical trial.
  • •Participation in a clinical research trial with any investigational drug/placebo within 3 months of screening (Visit 1) or concomitantly with this clinical trial.
  • •Personal, financial or other dependent relationship (e.g., employee or immediate relative) with the clinical trial site, Sponsor, Sponsor's representative, or another individual who has access to the clinical trial protocol.
  • •Vulnerable subjects or those in judicial or governmental detention, detainment or imprisonment in a public institution.

研究组 & 干预措施

Part A - Group A2

Experimental

Adult peanut allergic subjects, will undergo skin prick tests with ascending concentrations of VLP Peanut.

干预措施: VLP Peanut (Biological)

Part A - Group A1

Experimental

4 parallel cohorts (1-4) of adult healthy subjects. Each cohort will receive 6 ascending subcutaneous administrations of VLP Peanut.

干预措施: VLP Peanut (Biological)

Part B - Cohorts 1-4

Experimental

4 parallel cohorts (1-4) of peanut allergic subjects. Each cohort will receive 6 ascending subcutaneous administrations of VLP Peanut.

干预措施: VLP Peanut (Biological)

Part B - Cohorts 1-4

Experimental

4 parallel cohorts (1-4) of peanut allergic subjects. Each cohort will receive 6 ascending subcutaneous administrations of VLP Peanut.

干预措施: Placebo (Biological)

结局指标

主要结局

Number and severity of Adverse Events (AEs) (including local and systemic AEs).

时间窗: Group A1: 18 weeks; Part B: 64 weeks (Part B). Group A2: 3 days.

Number of subjects discontinuing prematurely from treatment due to AEs

时间窗: Group A1: 11 weeks Part B: 15 weeks

次要结局

  • Frequency of sore throat(Group A1: 14 weeks Part B: 16 weeks)
  • Wheal sizes after SPT in subjects with PA (Part A only)(15-20 minutes after skin pricking)
  • Alterations in urinalysis (glucose)(Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks)
  • Alterations in Serum Chemistry (albumin)(Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks)
  • Alterations in Serum Chemistry (chloride)(Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks)
  • Frequency of fatigue (tiredness)(Group A1: 14 weeks Part B: 16 weeks)
  • Incidence of headache(Group A1: 14 weeks Part B: 16 weeks)
  • Incidence of muscle pain(Group A1: 14 weeks Part B: 16 weeks)
  • Frequency of muscle pain(Group A1: 14 weeks Part B: 16 weeks)
  • Incidence of chills(Group A1: 14 weeks Part B: 16 weeks)
  • Alterations in Serum Chemistry (Uric Acid)(Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks)
  • Alterations in Serum Chemistry (Creatinine)(Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks)
  • Alterations in Serum Chemistry (alkaline phosphatase)(Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks)
  • Alterations in Serum Chemistry (aspartate aminotransferase)(Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks)
  • Alterations in hemoglobin levels(Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks)
  • Incidence of cough(Group A1: 14 weeks Part B: 16 weeks)
  • Incidence of sore throat(Group A1: 14 weeks Part B: 16 weeks)
  • Incidence of runny nose(Group A1: 14 weeks Part B: 16 weeks)
  • Incidence of fever (i.e. body temperature equal or above 38ºC (100.4ºF))(Group A1: 14 weeks Part B: 16 weeks)
  • Respiratory and Cardiovascular System Alterations as assessed by brief physical examination(On each dosing day - Group A1/Group part B: pre-dose and 30+/-10 minutes post dose; Group A2: pre-skin pricking and 1 hour post-skin pricking)
  • Alterations in urinalysis (bilirubin)(Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks)
  • Alterations in Urinalysis (leukocytes)(Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks)
  • Alterations in Serum Chemistry (Glucose)(Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks)
  • Incidence of fatigue (tiredness)(Group A1: 14 weeks Part B: 16 weeks)
  • Frequency of headache(Group A1: 14 weeks Part B: 16 weeks)
  • Frequency of cough(Group A1: 14 weeks Part B: 16 weeks)
  • Frequency of fever (i.e. body temperature equal or above 38ºC (100.4ºF))(Group A1: 14 weeks Part B: 16 weeks)
  • Alterations in urinalysis (protein)(Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks)
  • Alterations in urinalysis (ketones)(Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks)
  • Alterations in Urinalysis (blood)(Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks)
  • Alterations in Serum Chemistry (Sodium)(Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks)
  • Frequency of chills(Group A1: 14 weeks Part B: 16 weeks)
  • Alterations in urine pH(Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks)
  • Alterations in urinalysis (urobilinogen)(Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks)
  • Alterations in Serum Chemistry (phosphorus)(Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks)
  • Alterations in White Blood Cells (WBC) levels(Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks)
  • Frequency of runny nose(Group A1: 14 weeks Part B: 16 weeks)
  • Alterations in the lung function(Group A1 and Group Part B: On each dosing day pre-dose and 30 to 60 minutes post-dose; Group A2: pre skin pricking and 1 hour post skin pricking)
  • Alterations in urinalysis (nitrite)(Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks)
  • Alterations in Serum Chemistry (Urea)(Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks)
  • Alterations in Serum Chemistry (Calcium)(Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks)
  • Alterations in Serum Chemistry (total bilirubin)(Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks)
  • Alterations in Serum Chemistry (lactate dehydrogenase)(Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks)
  • Alterations in Serum Chemistry (Alanine aminotransferase)(Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks)
  • Alterations in Serum Chemistry (C-reactive protein)(Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks)
  • Alterations in the hematocrit(Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks)
  • Alterations in Serum Chemistry (total protein)(Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks)
  • Alterations in Serum Chemistry (cholesterol)(Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks)
  • Alterations in Serum Chemistry (gamma-glutamyl transferase)(Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks)
  • Platelet counts alterations(Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks)
  • Alterations in Serum Chemistry (potassium)(Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks)
  • Alterations in Red Blood Cells (RBC) levels(Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks)
  • Serum/Urine Pregnancy Test(Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks)

研究者

发起方
Allergy Therapeutics
申办方类型
Industry
责任方
Sponsor

研究点 (10)

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