ISRCTN59409907已完成1 期
A phase 1 double-blind, randomized, two-arm, two-way crossover, sequential two-stage study to assess the pharmacokinetic comparability of first and second generation RO7490677 (recombinant human pentraxin-2; rhPTX-2) drug products in healthy subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
研究概览
简要总结
2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38651245/ (added 24/04/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age between 18 and 70 years, both inclusive
- •2. Within body mass index (BMI) range 18.0 to 36.0 kilogram per square metre (kg/m²), both inclusive
- •3. Negative hepatitis panel (hepatitis B surface antigen, hepatitis B virus core antibody total, and hepatitis C virus antibody) and negative human immunodeficiency virus (HIV) p24 antigen/antibody screens
- •4. Negative screening test for active or latent Mycobacterium tuberculosis (TB) infection by QuantiFERON® TB Gold Plus
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, immunological, neurological, or psychiatric disorder; acute infection; or other unstable medical disease, as determined by the investigator
- •2. History of moderate or severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins
- •3. History or presence of any malignancy, except for completely excised basal cell or squamous cell carcinoma of the skin
- •4. History or presence of a clinically significant ECG abnormality, as determined by the investigator, or known history of family history of a prolonged QT interval syndrome
- •5. History or presence of atrial fibrillation
- •6. History of uncontrolled hypertension, hyperlipidemia, thyroid disorder, or diabetes, as determined by the investigator
- •7. History of active or latent TB, regardless of treatment history
- •8. Use of oral antibiotics within 4 weeks or IV antibiotics within 8 weeks prior to Screening
- •9. Administration of a vaccine (including seasonal flu, H1N1, and Coronavirus Disease 2019 [COVID-19] vaccine) in the past 30 days prior to dosing
- •10. Evidence of current/positive test result for severe acute respiratory syndrome coronavirus 2 (i.e., the virus that causes COVID-19) infection at Screening or Check-in
- •11. Donation of blood within 30 days prior to Screening through study completion, inclusive, or of plasma within 2 weeks prior to Screening through study completion, both inclusive
- •12. Receipt of blood products within 2 months prior to Check-in
- •13. Female participants who are pregnant, lactating, or breastfeeding.
- •Other protocol-specified exclusion criteria may apply.
研究者
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