NL-OMON56208招募中不适用
A randomized, double-blind, placebo-controlled, first-in-human phase 1 study evaluating safety, tolerability, and pharmacokinetics of single ascending doses of SOL-116 (a humanized monoclonal anti-BSSL antibody) in healthy subjects and patients with rheumatoid arthritis. - CS0382-210463
ipum AB0 个研究点目标入组 72 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
- 招募中
- 发起方
- 入组人数
- 72
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
- •1. Willing and able to give written informed consent for participation in the
- •study and is willing and able to abide by the study restrictions.
- •2. Males and females aged between 18 and 65 years (inclusive) at Screening. For
- •patients in the RA cohort, an age interval between 18 and 70 years (inclusive).
- •3. Normal clinically physical findings, apart from RA specific findings
- •(including deviating laboratory values e.g., mild anaemia or swollen joints)
- •for RA patients, including pulse rate, blood pressure, electrocardiogram (ECG),
- •physical examination, and laboratory values (haematological/clinical chemistry)
- •as judged by the Investigator. Healthy subjects must be negative for anti-CCP
- •and have Rheumatoid Factor <1.5 ULN at Screening.
- •4. For Parts 1 and 3, body mass index (BMI) between 19.0 and 30.0 kg/m2 and
- •body weight between 50 to 100 kg (inclusive) at Screening. For Part 2, body
- •weight between 50 to 120 kg (inclusive) at Screening.
- •5. Sexually active male patients participating in the study must use a barrier
- •method of contraception (condom) and refrain from sperm donation during the
- •study and for at least 150 days after last dosing if their female sexual
- •partner is of childbearing potential. Acceptable methods of birth control for
- •female partners of male subjects are: hormonal contraceptives (oral
- •contraceptives, implant or injection), intrauterine device (placed at least 1
- •month before the start of the study). Surgical sterilization of male patients
- •can be accepted as a form of birth control if the sterilization procedure took
- •place at least 6 months prior to the start of the study.
- •6. Females of childbearing potential must during the study and for at least 230
- •days after last dosing utilise a method of contraception that can achieve a
- •failure rate of less than 1% per year when used consistently and correctly.
- •Such highly effective birth control methods include:
- •combined (estrogen and progestogen containing) hormonal contraception
- •associated with inhibition of ovulation:
- •o intravaginal
- •o transdermal
- •progestogen-only hormonal contraception associated with inhibition of
- •o injectable
- •o implantable
- •intrauterine device (IUD)
- •intrauterine hormone-releasing system (IUS)
- •bilateral tubal occlusion
- •vasectomized partner
- •sexual abstinence
- •7. Females of non-childbearing potential must fulfil one of the following:
- •Irreversibly surgically sterile i.e., hysterectomy, bilateral salpingectomy,
- •the fallopian tubes have been blocked or sealed (sterilization), and bilateral
- •oophorectomy.
- •Spontaneous amenorrhoea during the last 12 months prior to enrolment, and
- •having follicle stimulating hormone (FSH) levels in the postmenopausal range
- •(i.e. >= 30 mIU/mL) at Screening.
- •The following inclusion criterion is only applicable for RA patients:
- •8.Fulfilling the 2010 American College of Rheumatology (ACR)/European Union
- •League Against Rheumatism (EULAR) classification criteria for RA [8].
- •Treatment with MTX for at least 12 weeks prior to treatment start and planned
- •to continue with MTX during the study; if the MTX dose was changed during the
- 另有 3 项未显示
排除标准
- •1. History of any clinically significant acute inflammatory joint disease (for
- •the RA cohort; other than RA).
- •2. Any chronic or long-lasting disease which may interfere with the study
- •objectives or jeopardise the safety of the subjects/patients as judged by the
- •Investigator or responsible physician (for the RA cohort; other than RA).
- •3. Ongoing infection on Day-1.
- •4. Serious infection treated with antibiotics and evaluated by physician in the
- •past 14 days prior to Day -1.
- •5. Current treatment with heparin products.
- •6. Use of any prescription or non-prescription drugs (excluding paracetamol,
- •hormonal contraceptives), antacids, herbal, and dietary supplements (including
- •St John*s Wort) within 14 days (or 28 days if the drug is a potential hepatic
- •enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose
- •of study drug for healthy subjects and within 4 weeks prior to the first dose
- •of study drug for RA patients, unless in the opinion of the Investigator the
- •medication will not interfere with the study procedures or compromise
- •subject/patient safety. In RA patients, MTX and folic acid use are exempted.
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