NL-OMON21868招募中不适用
A Phase I, Randomized, Double-Blind, Placebo-controlled, Placebo-Controlled Study to Evaluate the Safety and Activity of Repeated Intranasal Administration of Ampligen® (Poly I:Poly C12U) in Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
研究概览
简要总结
.A.
研究设计
- 研究类型
- Interventional
入排标准
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;
- •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;
- •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);
- •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 study);
- •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;
- •15. Receipt of any vaccine within 1 week prior to IMP administration, or planning to get vaccinated during the study;
- •16. Therapy with interferons, interleukins, or other cytokines within 6 weeks of first dosing;
- •17. Known hypersensitivity to Ampligen or its excipients;
- •18. If a woman, pregnant, or breast feeding, or planning to become pregnant during the study;
- •19. Any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease.
- •20. History of Bell’s Palsy or other forms of facial paralysis.
- •21. Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening, or donation of plasma within 14 days of screening or intention to donate blood or blood products during
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