NL-OMON56333招募中不适用
A first-in-human, randomized, double-blind, placebo-controlled study to evaluate, single ascending doses of CIT-013 in healthy volunteers with and without an intravenous lipopolysaccharide challenge and repeat dosing in healthy volunteers and patients with Rheumatoid Arthritis. - CIT013 First in Human study
Citryll0 个研究点目标入组 84 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 84
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 64（—）
入选标准
- •lnclusion criteria part A- C, and HVs part D
- •Eligible subjects must meet all the following criteria at screening:
- •1. Healthy men or women, 18 to 55 years of age (inclusive) at screening. For
- •part B cohort 2 only healthy men will
- •be included. The health status is verified by absence of evidence of any
- •clinically significant activa or uncontrolled
- •chronic disease following a detailed medical history, a complete physical
- •examination including vital signs,
- •laboratory measurements, and 12-lead ECG;
- •2. Signed infonmed consent, able and willing to comply wilh the requirements of
- •the study protocol.
- •3. Body mass index (BMI) between 18 and 32 kg/m2, inclusive, and a body weight
- •between 50 and 150 kg,
- •inclusive at screening.
- •4. All male and Women of Child Bearing Potenlial volunteers must practica
- •effeclive contraception during the
- •study and be willing and able to continue contraception for at least 90 days
- •after !heir last dose of study treatment.
- •5. Has the ability to communicate well with the lnvestigator in the Dutch
- •language and willing to comply with the
- •study restriclions.
- •lnclusion criteria part D (patients)
- •Eligible subjects must meet all the following criteria at screening:
- •1. Men or women 18 to 75 years of age (inclusive) at screening diagnosed with
- •RA (and fulfilling the ACR 2010 classification criteria for RA) for at least 6
- •2. Signed informed consent, able and willing to comply with the requirements of
- •the study protocol.
- •3. Body mass index (BMI) between 18 and 35 kg/m2, inclusive, and a body weight
- •between 50 and 150 kg,
- •inclusive at screening.
- •4. All male and Women of Child Bearing Potential volunteers must practica
- •effective contraception during the
- •study and be willing and able to continue contraception for at least 90 days
- •after !heir last dose of study treatment.
- •5. Has the ability to communicate well with the lnvestigator in the Dutch
- •language and willing to comply with the
- •study restrictions.
- •6. If on conventional DMARD, should be stable on a conventional DMARD (i.e.
- •methotrexate, sulfasalazine, leflunomide and (hydroxy)chloroquine) (and
- •steroids) for at least 8 weeks and willing to continue current stable treatment
- •for 6 Weeks. Current treatment with
- •non-conventional DMARDs, including monoclonal antibodies, is not allowed.
- •Prednisolone <= 10 mg / day is permitted.
排除标准
- •Exclusion criteria part A- C, and HVs in part D
- •Eligible subjects must not meet any of the following criteria at screening or
- •1. Evidence (following a detailed medical history, physical examination, vital
- •signs, 12-lead ECG and clinical
- •laboratory parameters) of any active or chronic disease or condition that could
- •interfere with, or for which the
- •treatment might interfere with, the conduct of the study, or that would pose an
- •unacceptable risk to the subject in
- •the opinion of the investigator.
- •2. Clinically significant abnormalities, as judged by the investigator, in
- •laboratory test results (including hepatic and
- •renal panels, complete blood count, chemistry panel and urinalysis). Minor
- •deviations of laboratory values from the
- •normal range may be accepted, if judged by the lnvestigator or medically
- •qualified designee as not clinically
- •significant. In the case of uncertain or questionable results, tests performed
- •during screening may be repeated
- •before randomization to confirm eligibility or judged to be clinically
- •irrelevant for healthy subjects.
- •3. Any confirmed or suspected disease or condition associated with immune
- •system impairment, including autoimmune
- •diseases, HIV, asplenia or recurrent severe infections.
- •4. Use of chronic (more than 14 days) immunosuppressant or immunomodulatory
- •drugs within the 3 months prior
- •to IMP administration, or isolated (non-chronic) use within 30 days prior to
- •IMP administration.
- •5. Any history of severe allergie reaction(s).
- •6. Any confirmed significant drug hypersensitivity reactions (including skin
- •reactions or anaphylaxis), or known
- •allergies (non-active hay lever is acceptable).
- •7. Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab),
- •or human immunodeficiency virus
- •antibody (HIV Ab) at screening, or other known infection requiring systemic
- •antibiotic therapy within three months
- •prior to the study.
- •8. Subject has an active, uncontrolled acute or chronic systemic fungal,
- •bacterial, and/or viral, infection within the
- •past 30 days.
- •9. Subjects with evidence or history of clinically significant haematological,
- •renal, endocrine, pulmonary,
- •gastrointestinal, cardiovascular, hepatic, psychiatrie, neurologie diseases.
- •10. Subjects with a positive urine drug screen at screening or pre-dose.
- •11. Subject has a positive SARS-CoV-2 PCR based testwithin 72 hours prior to
- •receiving CIT-013.
- •12. History of abuse of addictive substances (alcohol, illegal substances) or
- •current use of more than 14 units
- •alcohol per week (in partAand B) and 14 units for females and 21 units lor
- •males (in part C), drug abuse, or
- •regular user of sedatives, hypnotics, tranquillisers, or any other addictive
- •13. Treatment with an investigational drug within 30 days or 5 half-lives
- 另有 11 项未显示
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