NCT07142642已完成1 期
A Phase 1, Randomized, Placebo-controlled, Double-blind, Single-dose Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Teprotumumab (AMG 632) Administered Intravenously in Healthy Chinese Participants
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Maximum Observed Serum Concentration (Cmax) of Teprotumumab
研究概览
简要总结
The primary objective of the study is to evaluate the pharmacokinetics (PK) of teprotumumab after a single intravenous (IV) infusion of teprotumumab in healthy Chinese participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant has provided informed consent.
- •Participants must be a resident in mainland China, and of Chinese ancestry (participants whose parents within 3 generations are of Chinese ancestry).
- •Male or female participants, between 18 and 60 years of age (inclusive). Female participants must be of nonchildbearing potential.
- •In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations.
- •Body mass index between 18 and 27 kg/m^2 (inclusive) and minimum weight of 55 kg .
排除标准
- •History or evidence of clinically significant disorder, condition, or disease.
- •History of diabetes. (regardless of type with the exception of history of gestational diabetes). Hemoglobin A1C greater than or equal to 6.5% (greater than or equal to 48 mmol/mol).
- •Fasting glucose level (after at least an 8-hour fast) > 126 mg/dL (> 7 mmol/L).
- •History of or ongoing hearing impairment.
- •History of any autoimmune disease, inflammatory bowel disease, or TED.
- •History or evidence of ECG-findings.
- •Systolic blood pressure ≥ 140 mmHg or < 90 mmHg, or diastolic blood pressure ≥ 90 mmHg or < 50 mmHg, or pulse > 100 bpm or < 50 bpm , at screening or check-in.
- •History of relevant drug and/or food allergies.
- •Poor peripheral venous access and/or unable to receive IV infusion therapy.
- •Estimated glomerular filtration rate less than 90 mL/min/1.73 m
- •Active liver disease or hepatic dysfunction.
- •History of a medical condition associated with an increased risk of bleeding.
- •History of any major surgery within 6 months.
- •History of alcoholism or drug/chemical abuse within 1 year prior to check-in.
- •Use of tobacco- or nicotine-containing products within 6 months prior to check-in.
- •Positive test for illicit drugs and/or tetrahydrocannabinol/cannabinoids at check-in.
- •Female participants with a positive serum pregnancy test.
- •Female participants who are lactating/breastfeeding.
- •Male participants with partners who are pregnant.
- •Unwilling to adhere to contraceptive requirements.
- •Participant has received a dose of an investigational drug within the past 90 days.
- •Have previously completed or withdrawn from this study or any other study investigating teprotumumab or have previously received the investigational product.
研究组 & 干预措施
Teprotumumab
Experimental
Participants will be randomized 3:1 to receive a single IV infusion of teprotumumab or placebo on Day 1.
干预措施: Teprotumumab (Drug)
Placebo
Placebo Comparator
Participants will be randomized 3:1 to receive a single IV infusion of teprotumumab or placebo on Day 1.
干预措施: Placebo (Drug)
结局指标
主要结局
Maximum Observed Serum Concentration (Cmax) of Teprotumumab
时间窗: Up to Day 85
Area Under the Serum Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of Teprotumumab
时间窗: Up to Day 85
Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUCinf) of Teprotumumab
时间窗: Up to Day 85
次要结局
- Number of Participants With Treatment-emergent Adverse Events(Up to Day 85)
- Number of Participants With Serious Adverse Events(Up to Day 85)
- Number of Participants With Anti-teprotumumab Antibodies(Up to Day 85)
研究者
研究点 (1)
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