NL-OMON50834已完成不适用
A Phase I, Randomized, Placebo-controlled, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Activity of Repeated Intranasal Administration of Ampligen® (Poly I:Poly C12U) in Healthy Subjects - Intranasal Ampligen in healthy volunteers.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
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. Signed informed consent prior to any study-mandated procedure;
- •2. Male or female subjects, 18 to 70 years of age, inclusive at screening;
- •3. Body mass index (BMI) between 18 and 32 kg/m2, inclusive at screening, and
- •with a minimum weight of 50 kg.
- •4. Participant must be healthy, in the investigator*s clinical judgment, as
- •confirmed by medical history, physical examination, vital signs, ECG and
- •laboratory assessments performed at screening. Repeated laboratory testing may
- •be performed at the discretion of the clinical investigators for spurious
- •results on a case by case basis;
- •5. Willing to comply with effective contraception during the study if subject
- •is male or women of child bearing potential, up to 90 days after the last dose
- •of study treatment.
- •6. Has the ability to communicate well with the investigator in the Dutch
- •language and willing to comply with the study restrictions
排除标准
- •1. Evidence of any active or chronic disease or condition that could interfere
- •with, or for which the treatment of might interfere with, the conduct of the
- •study, or that would pose an unacceptable risk to the subject in the opinion of
- •the investigator (following a detailed medical history, physical examination,
- •vital signs (systolic and diastolic blood pressure, pulse rate, body
- •temperature) and 12-lead electrocardiogram (ECG). Minor deviations from the
- •normal range may be accepted, if judged by the Investigator to have no clinical
- •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. 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
- •3. Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV ab),
- •or human immunodeficiency virus antibody (HIV ab) at screening;
- •4. Respiratory tract infection (including flu and common cold symptoms) or any
- •febrile illness (>38°celsius) in the period of 3 days before first treatment
- •administration;
- •5. Presence of respiratory viral infection as determined by respiratory panel
- •on nasal swab at baseline (including positive SARS-CoV-2 PCR test);
- •6. History of chronic respiratory diseases (e.g. chronic obstructive pulmonary
- •disease, emphysema, chronic rhinitis or sinusitis, asthma or other reactive
- •airway diseases) in adulthood. Childhood asthma and non-active allergic
- •rhinitis (including hay fever) will be permitted at the discretion of the
- •investigator;
- •7. History of frequent nose bleeds;
- •8. Significant anatomical nasal abnormalities or other nasal abnormalities that
- •might impact the study executions (including, but not limited to, nasal septal
- •defects, cleft palate, nasal polyps, previous nasal cautery or surgery that
- •impacts study assessments);
- •9. Immunocompromised (known or expected immune deficiency, disease, or use of
- •medication that may affect the immune system) or evidence of autoimmune
- •disorder (deemed clinically relevant by the investigator);
- •10. Participation in an investigational drug or device study (last dosing of
- •previous study was within 90 days or 5 half-lives prior to first dosing of this
- •11. History of abuse of addictive substances (alcohol, illegal substances) or
- •current use of more than 21 units of alcohol per week, drug abuse, or regular
- •user of sedatives, hypnotics, tranquillisers, or any other addictive agent;
- •12. Positive test for drugs of abuse at screening or pre-dose. Drugs test may
- •be repeated;
- •13. A routine smoker of tobacco products, currently or in the past year. No
- •(incidental) smoking will be allowed in the two weeks prior to first dosing;
- •14. Use of immunomodulatory drug; including systemic corticosteroids as well as
- •nasal preparations within 30 days before first dosing. Low dose topical use of
- •corticosteroids will be permitted. Other exceptions will only be made if the
- •rationale is clearly documented by the investigator;
- •15. Receipt of any vaccine within 1 week prior to IMP administration, or
- •planning to get vaccinated during the study;
- •16. Therapy with interferons, inte
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