NL-OMON54131已完成不适用
A randomized, double-blind, placebo-controlled study of the tolerability, pharmacokinetics and pharmacodynamics of ascending single and repeated subcutaneous doses of SAR444336 in healthy adult participants - Safety, PK and PD of SAD and MAD of SAR444336 in HV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
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
- •- Male and female participants between 18 and 55 years of age inclusive.
- •- Participants who are overtly healthy as determined by medical evaluation
- •including medical history, physical examination, laboratory tests, and ECG.
- •- Laboratory values within normal range unless the abnormality is considered
- •not clinical relevant by the investigator.
- •- Eosinophils <500 cells/µL
- •- Normal vital signs after 10 minutes resting in supine position
- •- Standard 12-lead ECG parameters after 10 minutes resting in supine position
- •in the normal ranges and normal ECG tracing unless the Investigator considers
- •an ECG tracing abnormality to be not clinically relevant.
- •- Body weight between 50 - 110 kg (inclusive) and body mass index (BMI) between
- •18 - 30*kg/m2 (inclusive) at screening.
- •- Male participants between 18 and 55 years of age inclusive.
- •- Participants who are overtly healthy as determined by medical evaluation
- •including medical history, physical examination, laboratory tests, and ECG.
- •- Laboratory values within normal range unless the abnormality is considered
- •not clinical relevant by the investigator.
- •- Eosinophils <500 cells/µL
- •- Normal vital signs after 10 minutes resting in supine position
- •- Standard 12-lead ECG parameters after 10 minutes resting in supine position
- •in the normal ranges and normal ECG tracing unless the Investigator considers
- •an ECG tracing abnormality to be not clinically relevant.
- •- Body weight between 50 - 110 kg (inclusive) and body mass index (BMI) between
- •18 - 30*kg/m2 (inclusive) at screening.
- •- Fitzpatrick skin type I - III
排除标准
- •- Any disease associated with immune system dysfunction.
- •- Known polyethylene glycol allergy
- •- Any current active viral, bacterial or fungal infection or any medically
- •relevant infection having occurred within 3 weeks before inclusion.
- •- Any history or presence of clinically relevant cardiovascular, pulmonary,
- •gastrointestinal, hepatic, renal, metabolic, hematological, neurological,
- •osteomuscular, articular, psychiatric, autoimmune, systemic, ocular, or
- •infectious disease, or signs of acute illness that would pose an unacceptable
- •risk to the subject in the opinion of the investigator.
- •- Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for
- •vomiting only, more than twice a month).
- •- Blood donation >500 mL within 2 months before inclusion.
- •- Symptomatic postural hypotension, irrespective of the decrease in blood
- •pressure, or asymptomatic postural hypotension defined as a decrease in
- •systolic blood pressure >=30*mmHg within 3 minutes when changing from supine to
- •standing position.
- •- Presence or history of drug hypersensitivity, or allergic disease diagnosed
- •and treated by a physician, except for history of mild allergic diseases which
- •are not active at the time of inclusion and considered not clinically relevant
- •in the opinion of the investigator.
- •- History or presence of drug or alcohol abuse.
- •- Smoking regularly more than 10 cigarettes or equivalent per week, unable to
- •stop smoking during the study (occasional smoker can be enrolled).
- •- Excessive consumption of beverages containing xanthine bases.
- •- Presence or history of any atopic disease.
- •- Non-live vaccines including: last administration of a vaccine within 4 weeks
- •before randomization; non-live COVID-19 (booster) vaccination within 14 days
- •before randomization. First (and second, if applicable) COVID-19 vaccinations
- •are not allowed within 4 weeks before randomization.
- •- Live vaccines: Last administration of a vaccine within 3 months before
- •randomization.
- •- Immunomodulatory medication within 60 days before screening.
- •- Any medication (including St John*s Wort) within 14 days before inclusion or
- •within 5*times the elimination half-life or pharmacodynamic half-life of the
- •medication; any vaccination within the last 28 days (except COVID-19 booster
- •vaccination) and any biologics (antibody or its derivatives) given within 4
- •months before inclusion.
- •- Positive result on any of the following tests: hepatitis B surface (HBs Ag)
- •antigen, antihepatitis B core antibodies (anti-HBc Ab), anti-hepatitis C virus
- •(anti-HCV) antibodies, anti-HIV1 and anti HIV2 Ab.
- •- Positive result on urine drug screen.
- •- Positive alcohol breath or urine test.
- •- Participants are excluded from the study if any of the following criteria
- •- Any disease associated with immune system dysfunction.
- •- Known seafood allergy
- •- Known polyethylene glycol allergy
- •- Any current active viral, bacterial or fungal infection or any medically
- •relevant infection having occurred within 3 weeks before inclusion.
- •- Any history or presence of clinically relevant cardiovascular, pulmonary,
- •gastrointestinal, hepatic, renal, metabolic, hematological, neurological,
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