JPRN-jRCT2071210021已完成1 期
Investigation of safety, tolerability and pharmacokinetics of subcutaneously co-administered single doses of NNC0480-0389 and semaglutide in healthy Japanese male subjects
Hashida Masahiro0 个研究点目标入组 24 人开始时间: 2021年5月11日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
Single doses of co-administered NNC0480-0389 s.c. (up to 30 mg) and semaglutide s.c. (0.5 mg) were well-tolerated and no safety concerns were identified in healthy Japanese male subjects. -NNC0480-0389 exposure (AUC0-oo and Cmax) increased in a dose proportional manner. -The observed half-life of NNC0480-0389 was approximately 5 days. -Semaglutide exposure (AUC0-oo and Cmax) was not significantly affected across the three NNC0480-0389 levels.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 55age old（—）
- 性别
- Male
入选标准
- •Male aged 20-55 years (both inclusive) at the time of signing the informed consent.
- •- Both parents of Japanese descent.
- •- Body mass index between 20.0 kg/m2 and 24.9 kg/m2 (both inclusive).
- •- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
排除标准
- •-Any disorder which in the investigators opinion might jeopardise subjects safety or compliance with the protocol.
- •- HbA1c >= 6.5% (48 mmol/mol) at screening.
- •- Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of acetaminophen, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation within 14 days prior to the day of screening.
- •- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
研究者
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