健康な中国人参加者におけるレムターネタグ(LY3372993)の研究
健康な中国人参加者におけるレムターネタグ単回投与の安全性、忍容性、および薬物動態を検討する研究
The study will evaluate the safety and tolerability of remternetug when given subcutaneously (SC) (under the skin) to healthy Chinese participants. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. The study will last up to 25 weeks, including screening period.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (実際)
入学
段階
段階
- フェーズ 1
連絡先と場所
研究場所
-
-
-
Beijing、中国、100053
- Xuanwu Hospital Capital Medical University
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Xuhui District、中国、20031
- Shanghai Xuhui Central Hospital
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-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, electrocardiogram (ECG), and Magnetic resonance imaging (MRI).
- Participants must be native Chinese. To qualify as Chinese for this study, the participant, the participant's biological parents, and all 4 of the participant's biological grandparents must be of exclusive Chinese descent and born in China.
- Have clinical laboratory test results within normal reference ranges for the population or study site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.
- Have a body mass index within the range 18.0 to 28.0 kilograms per square meter (kg/m²), inclusive.
- Are individuals Assigned Male at Birth (AMAB) or individuals Assigned Female at Birth (AFAB) who are individuals not of childbearing potential (INOCBP). Individual of childbearing potential (IOCBP) are excluded from the trial.
Exclusion Criteria:
- Are women who are lactating.
- Have known allergies to remternetug, related compounds, including donanemab, or any components of the formulation.
- Have history of allergies to medications for the emergency treatment of systemic hypersensitivity reactions, including anaphylaxis or infusion reactions (for example, epinephrine, diphenhydramine).
- Have a 12-lead ECG abnormality at screening that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG data analysis.
- Have an abnormal blood pressure or pulse rate as determined by the investigator, or a preexisting history of hypertension.
- Have a history or presence of significant psychiatric disorders.
- Have a brain MRI that demonstrates any clinically significant findings that in the opinion of the investigator may impact the participant's ability to safely participate in the study.
- Have a family history of early onset Alzheimer's disease (AD) (AD diagnosed prior to 65 years of age).
- Have a history or presence of clinically significant multiple or severe drug allergies or severe posttreatment hypersensitivity reactions, including, but not limited to, erythema multiforme major, linear immunoglobulin A (IgA) dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis.
- Have history or presence of uncontrolled asthma, significant autoimmune disease, hereditary angioedema, or known history of common variable immune deficiency.
- Have a history or presence of serious or unstable illnesses including cardiovascular, hepatic, renal, gastrointestinal, respiratory, endocrine, psychiatric, immunologic, hematologic disease, or neurological disorders and other conditions that, in the investigator's opinion, could significantly alter the absorption, metabolism, or elimination of drugs; interfere with the analyses in this study; increase risk for study intervention administration; or result in a participant's life expectancy of less than 24 months.
- Have significant neurological disease affecting the central nervous system that may affect the participant's ability to complete the study, including but not limited to dementias, serious infection of the brain, Parkinson's disease, multiple concussions, intracranial hemorrhage, cerebrovascular aneurysm or arteriovenous malformation, or carotid artery occlusion, stroke, unprovoked seizure, epilepsy, or recurrent seizures (except febrile childhood seizures).
- Have donated blood of more than 400 milliliter (mL) within the previous 4 weeks of study screening, or plan for blood donation during the study period.
- Have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- Have had significant medical history of dizziness, syncope, or vasovagal attacks within the past 3 years.
- Have used or intend to use over-the-counter, prescription, or Chinese traditional medicines and herbal supplements within 14 days or 5 half-lives (whichever is longer) prior to dosing. Vitamins and mineral supplements not providing more than 100% of the recommended daily amount and thyroid hormone replacement are allowed.
- Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.
- Show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies.
- Have a positive Hepatitis C virus (HCV) antibody test. Participants with a positive HCV antibody test at screening can be included only if a confirmatory HCV ribonucleic acid (RNA) test is negative.
- Show evidence of hepatitis B or positive hepatitis B surface antigen. Other Exclusion Criteria
- Have an average weekly alcohol intake that exceeds 21 units per week for males and 14 units per week for females; 1 unit = 12 ounce (oz) or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits.
- Are unwilling to stop alcohol consumption for 48 hours prior to admission to the study site or outpatient visits.
- Smoke more than 10 cigarettes per day or the equivalent including electronic cigarettes, are unwilling to refrain from smoking for approximately 1 hour prior to each ECG and vital sign measurement during the study, or are unable to abide by CRU smoking restrictions.
- Have Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), or Alkaline Phosphatase (ALP) greater than or equal to 1.5× Upper Limit of Normal (ULN) at screening.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:基礎科学
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
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実験的:Remternetug
Remternetug will be administered subcutaneously (SC) |
Administered SC
他の名前:
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プラセボコンパレーター:Placebo
Placebo will be administered Subcutaneously (SC) |
Administered SC |
この研究は何を測定していますか?
主要な結果の測定
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
治験責任医師が試験薬投与に関連すると判断した、1つ以上の重篤な有害事象(SAE)を有する参加者数
時間枠:ベースラインから研究完了までの最大25週間
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ベースラインから研究完了までの最大25週間
|
二次結果の測定
二次結果の測定
結果測定 |
時間枠 |
|---|---|
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薬物動態学(PK):レムターネトゥグの最大血中濃度(Cmax)
時間枠:1日目から5日目まで
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1日目から5日目まで
|
|
PK:レムターネタグの濃度-時間曲線下面積(AUC)
時間枠:1日目から5日目
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1日目から5日目
|
協力者と研究者
捜査官
捜査官
- スタディディレクター:Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)、Eli Lilly and Company
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (実際)
一次修了
研究の完了 (実際)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- 18470
- J1G-GH-LAKE (その他の識別子:Eli Lilly and Company)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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