jRCT2033260217招募中不适用
Phase 1, First-in-Human (FIH), Ascending Dose study to assess the Safety, Tolerability and Preliminary Immunogenicity of ITI-9001 in Japanese patients with Japanese Red Cedar (JRC) Pollinosis: A two-part design Consisting of an Open-Label, Single-Arm Part A and a Randomized, Double-Blind, Part B
未提供0 个研究点目标入组 42 人开始时间: 待定
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 42
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
入排标准
- 年龄范围
- 18age old over 至 65age old under（—）
- 性别
- All
入选标准
- •Signed and dated informed consent form (ICF)
- •Female of non-childbearing potential or male aged 18-
- •Women are not considered to be of childbearing potential if they meet one of the following criteria as documented by the Investigator:
- •a They have had a hysterectomy or tubal ligation at a minimum of 1 cycle prior to signing the ICF; or
- •b They are postmenopausal, defined as absence of menstruation for at least 12 months without other medical causes for women 55 years of age, or absence of menstruation for at least 12 months without other medical causes and have a follicle stimulating hormone (FSH) level in the postmenopausal range for women less than 55 years of age
- •Confirmed JCP sensitivity by positive skin prick test (a wheal diameter greater than or equal to 3 mm).
- •Confirmed JCP sensitivity by ImmunoCAP (serum JCP-specific IgE greater than or equal to class 2).
- •A greater than or equal to 2 year history of seasonal rhinoconjunctivitis symptoms requiring medication upon JCP exposure
- •Contraception requirements:
- •a Women of non-childbearing potential: negative serum pregnancy test less than or equal to 3
- •days before first dose
- •b Men: surgically sterile, or agree to abstinence or use 2 highly effective methods of contraception during study and for 3 months after the last dose if the partner is of childbearing potential. Acceptable method of contraception is defined as a combination of male condom and either of the following method of contraception approved in Japan by the female partner:
- •i) Oral hormonal contraceptives (combined estrogen-progestin formulations or progestin-only formulations)
- •ii) Intrauterine device
- •iii) Intrauterine hormone-releasing system
- •No significant ischemic heart disease or myocardial infarction within 6 months before first study drug administration; adequate cardiac function at screening (QTcF less than or equal to 470 msec for females or less than or equal to 450 msec for males; average of measurements from triplicate ECGs) a Participants with ventricular arrhythmia will be assessed on a case-by case basis with sponsor and medical monitor.
- •Willing and able to participate and comply with all study procedures.
排除标准
- •Women of childbearing potential. Women are considered to be of childbearing potential if they do not meet either of the criteria specified in Inclusion Criteria #
- •Respiratory Function
- •a Fever greater than or equal to 38 degrees Celsius (100.4 degrees Fahrenheit) on day of study drug administration
- •b FEV1 of less than 80% as predicted on spirometry
- •c Current smoker/tobacco user.
- •d History of asthma requiring daily medication (except exercise-induced or mild intermittent asthma)
- •Contraindications
- •a Known allergy to ITI-9001 components.
- •b Contraindication to intramuscular injections or blood draws.
- •c History of intolerance or severe allergic reaction to previous immunotherapy.
- •d History of anaphylaxis requiring medical intervention (including severe reactions to mRNA vaccines).
- •Prior/Concurrent Treatments
- •a Participation in another therapeutic clinical trial within 30 days before screening.
- •b Prior or current immunotherapy for JCP.
- •c Specific or nonspecific immunotherapy within 1 year prior to screening.
- •d Biologics (e.g. anti-IgE, anti-IL-5, anti-TNF alpha)
- •e mRNA vaccine within 28 days before first study drug administration
- •f Live vaccine within 28 days or inactivated/toxoid vaccine within 7 days before first study drug administration.
- •g Chronic (more than 30 days) systemic corticosteroids (inhaled, oral, IM, IV, potent topical).
- •h Inability/ unwillingness to discontinue beta-blockers (atenolol, metoprolol, propranolol, etc.) up to 48 hours before first drug administration and during the study.
- •i Inability/unwillingness to comply with washout periods for antihistamines, and other allergy medications.
- •Medical History/Comorbidities
- •a Clinically significant abnormalities on physical exam, labs, or medical history that in the investigator's opinion jeopardize safety or validity of results (except HEENT findings consistent with allergic rhinitis).
- •b Malignant tumor diagnosed or treated within 5 years prior to first study drug administration (except adequately treated non-melanoma skin cancer or carcinoma in situ).
- •c Congenital or acquired immune deficiency or suppression (e.g. malignancy, infection, chemotherapy, radiation, corticosteroids).
- •d History of organ transplant, hematologic malignancy, or autoimmune disease.
- •e History of stroke, transient ischemic attack, unstable angina, myocardial infarction within 3 months prior to first study drug administration.
- •f Symptomatic congestive heart failure (NYHA Class III-IV), unstable angina, significant arrhythmia, or LVEF less than 45%.
- •g History of myocarditis or pericarditis.
- •h Risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of long QT) or use of medications known to prolong QT/QTc (except low-risk premedications such as diphenhydramine, famotidine,ondansetron).
- •i Clinically significant gastrointestinal, renal, hepatic, neurologic, or hematologic disease.
- •j HIV/AIDS, hepatitis B, or hepatitis C infection
- •k Recurrent sinusitis, urticaria, or angioedema within past 12 months prior to first study drug administration.
- •l Symptomatic overlap with JRC pollinosis requiring regular medications.
- •m Alcohol or drug abuse within 1 year before screening or current dependence.
研究者
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