NL-OMON51543已完成不适用
An Open-label, Multicenter Study to Assess the Safety, Pharmacokinetics and Pharmacodynamic Effects of THB001 in Adult Patients with Chronic Cold Urticaria - A study for the safety, PK and PD of THB001 in cold urticaria patients
Third Harmonic Inc.0 个研究点目标入组 11 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •-Diagnosis of chronic cold urticaria for at least 3 months.
- •-Participants must be refractory to antihistamine treatment.
- •-Participants must understand the nature of the trial and must provide signed
- •and dated written informed consent in accordance with local regulations before
- •the conduct of any trial-related procedures.
- •-Participants currently on an antihistamine must be on a stable dose for at
- •least 2 weeks prior to day 1 and must maintain the same stable dose throughout
- •the treatment period.
- •-Positive cold stimulation test assessed by TempTest®
- •-Healthy as determined by the Investigator
- •-Men and women, age 18-75 years
- •-Women of child-bearing potential must not be pregnant or lactating. Women of
- •child-bearing potential and their non-vasectomized partners must agree to use
- •two of the following contraceptive methods during the trial and for 90 days
- •after the (last) trial drug administration: non-hormonal intra-uterine
- •device/system, condom, diaphragm, cervical cap with spermicide. Hormonal
- •contraceptives may continue to be used but are not considered a highly
- •effective form of birth control for this study.
- •OR Women of child-bearing potential and their vasectomized partners must agree
- •to use one of the following contraceptive methods during the trial and for 90
- •days after the (last) trial drug administration: non-hormonal intra-uterine
- •device/system, condom, diaphragm, cervical cap with spermicide. Hormonal
- •contraceptives may continue to be used but are not considered a highly
- •effective form of birth control for this study.
- •OR Women of child-bearing potential must practice sexual abstinence (when this
- •is in line with her preferred and usual lifestyle) during the trial and for 90
- •days after the (last) trial drug administration.
排除标准
- •-Participants with acute urticaria and participants with non-cold chronic
- •inducible urticaria.
- •-Current/ongoing treatment with immunosuppressant drugs, leukotriene
- •antagonists, danazol, penicillin, angiotensin-converting inhibitors, and
- •griseofulvin
- •-Any previous treatment with CDX-0159.
- •-A positive test for drugs of abuse at Screening.
- •-A positive Hepatitis B surface antigen or positive Hepatitis C or human
- •immunodeficiency virus (HIV) antibody result at Screening.
- •-Abnormal clinically significant findings on the laboratory examinations at the
- •Screening (ALT, AST, TBL, greater than 1.5 times the upper limit of normal;
- •Hbg, platelet count, ANC, reticulocyte count, WBC, below the lower limit of
- •-Use of prescription or non-prescription drugs, vitamins, herbal, and dietary
- •supplements, unless in the opinion of the Investigator and the Medical Monitor
- •the medication will not interfere with the trial procedures or compromise
- •participant safety.
- •-Received or used an investigational product (including placebo) or device
- •within the following time period prior to the first dosing day in the current
- •trial: 90 days, 5 half-lives or twice the duration of the biological effect of
- •the investigational product (whichever is longer).
- •-A positive pregnancy test or lactation.
- •-A history or presence of a clinically significant hepatic, renal,
- •gastrointestinal, cardiovascular, endocrine, pulmonary, ophthalmologic,
- •immunologic, hematologic, dermatologic (other than chronic urticaria),or
- •neurologic abnormality.
- •-A clinically significant vital signs abnormality, as judged by the principal
- •investigator, at Screening.
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