NL-OMON55203已完成不适用
A double-blind, placebo-controlled, dose escalation study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of KCP506 in healthy subjects - SAD/MAD study investigating safety, tolerability, PK and PD of KCP506
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
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
- •Gender: male (all parts) or female (Parts A and B only)
- •Age: 18 to 55 years, inclusive, at screening
- •Weight: 50 to 105 kg, inclusive
- •Body mass index: 18.0 to 30.0 kg/m2, inclusive
- •Status: healthy subjects
排除标准
- •1. Previous participation in the current study.
- •2. Employee of PRA, CHDR or the Sponsor.
- •3. History of relevant drug and/or food allergies, per the Investigator*s
- •assessment.
- •4. Using tobacco products within 60 days prior to first drug administration
- •5. History of alcohol abuse or drug addiction (including cannabis products),
- •per the Investigator*s assessment.
- •6. Positive drug and/or alcohol screen (opiates, methadone, cocaine,
- •amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines,
- •tricyclic antidepressants, nicotine [cotinine - Parts A and B only]. and
- •alcohol) at screening or first admission to the clinical research center. Tests
- •may be repeated once at screening and once at admission in case of a suspected
- •false positive result.
- •7. 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).
- •8. Positive screen for hepatitis B surface antigen (HBsAg), antihepatitis C
- •virus (HCV) antibodies, or antihuman immunodeficiency virus (HIV) 1 and 2
- •antibodies.
- •9. Participation in a drug study within 60 days (Parts A and B) or 90 days
- •(Part C) or 5 drug elimination half-lives, whichever is longer) prior to the
- •first drug administration in the current study. Participation in more than 3
- •other drug studies in the 10 months prior to the first drug administration in
- •the current study.
- •10. Donation or loss of more than 100 mL of blood within 60 days prior to the
- •first drug administration. Donation or loss of more than 1.5 liters of blood
- •(for male subjects)/more than 1.0 liters of blood (for female subjects) in the
- •10 months prior to the first drug administration in the current study.
- •11. Significant and/or acute illness within 5 days prior to the first drug
- •administration that may impact safety assessments or be consistent with
- •COVID-19 infection, in the opinion of the Investigator.
- •12. Unsuitable veins for infusion or blood sampling.
- •13. Close contact with persons diagnosed with COVID-19 within 14 days prior to
- •14. Positive nasopharyngeal PCR test for SARS-CoV-2 on Day -1.
- •15. Receipt of a vaccine within 14 days prior to the first study drug
- •administration (Parts A and B) or either study drug administration (Part C).
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