NL-OMON53550已完成不适用
A phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of OMS1029 with single-dose intravenous and subcutaneous administration in healthy subjects - OMS1029 IV SC First-in-human SAD study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
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
- •1. Sex: male or female.
- •2. Age: 18 to 60 years, inclusive, at screening.
- •3. Body mass index (BMI): 18.0 to 30.0 kg/m2, inclusive, at screening.
- •4. Weight: 50 to 110 kg, inclusive, at screening.
- •5. Status: healthy subjects.
- •6. At screening, females must not be pregnant or lactating; nonpregnancy will
- •be confirmed for all females by a serum pregnancy test (minimum sensitivity 25
- •IU/L or equivalent units of β-human chorionic gonadotropin [β-hCG]) at
- •screening and at admission.
- •7. Females are a) not of childbearing potential (ie, surgically sterilized or
- •postmenopausal for >1 year); OR b) women of childbearing potential (WOCBP),
- •and, if sexually active with a fertile male partner, must agree to use adequate
- •contraception (see Section 3.4.8.1) from 4 weeks prior to Day 1 until 90 days
- •following the final follow-up visit.
- •8. Males, if not documented surgically sterilized (eg, vasectomy and
- •azoospermia) and sexually active with WOCBP partners, must agree to use
- •adequate contraception (see Section 3.4.8.1) from admission (Day 1) until 90
- •days after the final follow-up visit. In addition, males must be willing to
- •refrain from sperm donation during this time.
- •9. All prescribed medication must have been stopped at least 14 days prior to
- •admission to the clinical research center. An exception is made for hormonal
- •contraceptives, which may be used throughout the study.
- •10. All over-the-counter medication, vitamin preparations and other food
- •supplements, or herbal medications (eg, St. John*s Wort) must have been stopped
- •at least 7 days prior to admission to the clinical research center. An
- •exception is made for paracetamol, which is allowed up to admission to the
- •clinical research center. Furthermore, from admission onwards, the Investigator
- •may permit a limited amount of paracetamol for the treatment of headache or any
- •other pain.
- •11. Ability and willingness to abstain from alcohol during confinement and from
- •48 hours prior to admission and each ambulant visit to the clinical research
- •center; and to limit alcohol use to no more than 2 units per day on average on
- •all other study days (1 unit of alcohol equals approximately 250 mL of beer,
- •100 mL of wine, or 35 mL of spirits).
- •12. Good physical and mental health on the basis of medical history, physical
- •examination, clinical laboratory, ECG, telemetric monitoring (as applicable),
- •and vital signs, as judged by the Investigator.
- •13. Competent, willing, and able to sign and understand the informed consent
- •and any required privacy authorization prior to the initiation of any study
- •procedures including a request that a subject fast for any laboratory
- •evaluations and comply with protocol requirements.
排除标准
- •1. Previous randomization in the current study.
- •2. Employee of ICON or the Sponsor, or their immediate family member. Immediate
- •family is defined as current spouse, parent, natural or legally adopted child
- •(including a stepchild living in the household), grandparent, or grandchild of
- •Omeros or ICON employee.
- •3. Received a complement inhibitor within 6 months of screening.
- •4. History of relevant drug and/or food allergies. This includes any confirmed
- •significant allergic reactions (anaphylaxis or angioedema) to any drug, OMS1029
- •excipients, or multiple drug allergies (non-active hay fever is allowed per the
- •Investigator*s discretion).
- •5. Using tobacco and nicotine containing products within 30 days prior to the
- •6. History of alcohol abuse or drug addiction (including soft drugs like
- •cannabis products) within 1 years of screening or the unwillingness to agree to
- •abstain from alcohol and drugs throughout the study.
- •7. Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines
- •[including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic
- •antidepressants, and alcohol) at screening and admission to the clinical
- •research center.
- •8. Average intake of more than 24 units of alcohol per week (1 unit of alcohol
- •equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits).
- •9. Positive screen for SARS-CoV-2 (if required by local regulation and
- •guidelines), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV)
- •antibodies, or human immunodeficiency virus (HIV) 1 and 2 antibodies.
- •10. Participation in a drug study within 30 days prior to study drug
- •administration in the current study. Participation in 4 or more other drug
- •studies in the 12 months prior to study drug administration in the current
- •11. Donation or loss of more than 450 mL of blood within 60 days prior to study
- •drug administration. Donation or loss of more than 1500 mL of blood (for male
- •subjects)/more than 1000 mL of blood (for female subjects) in the 10 months
- •prior to study drug administration in the current study.
- •12. Plasma or platelet donation within 14 days prior to Day 1.
- •13. History of asplenia, hyposplenism, or splenectomy.
- •14. History of any significant medical, hematologic, liver, autoimmune,
- •neurologic, or psychiatric disorder that in the opinion of the Investigator
- •would make the patient unsuitable for participation in the study.
- •15. Any known skin condition that would affect SC dosing or interpretation of
- •injection or infusion site reactions.
- •16. Any major surgery, in the opinion of the Investigator, that is planned
- •during the study.
- •17. Inability to be venipunctured and/or tolerate venous access. This includes
- •unsuitable veins for infusion or blood sampling.
- •18. Pregnancy or intent to conceive during the course of the study.
- •19. Inability to comply with all protocol assessments including follow-up
- •20. Any other sound medical, psychiatric and/or social reason as determined by
- •the Investigator.
- •21. Significant active bacterial or viral infection within the 2 weeks prior to
- •22. Significant and/or acute illness within 5 days prior to study drug
- •administration that may impact safety assessments, in the opinion of the
- •Investigator.
研究者
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