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Comparing the Extent to Which Romosozumab (AMG 785) is Made Available in the Body When Administered as a Single SC Injection or as 2 SC Injections

2026年10月12日 更新者:Amgen

A Phase 1, Open-label, Randomized, Parallel Group Study to Evaluate the Relative Bioavailability of Romosozumab (AMG 785) 210 mg Administered as a Single SC Injection or 2 SC Injections in Healthy Participants

The primary objective of this trial is to evaluate the relative bioavailability of romosozumab administered as a single 2.34 mL subcutaneous (SC) injection from a prefilled syringe (PFS) or 2 x 1.17 mL SC injections from PFS in healthy participants.

調査の概要

状態

募集

介入・治療

研究の種類

介入

入学 (推定)

308

段階

  • フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:Amgen Call Center
  • 電話番号:866-572-6436
  • メール:medinfo@amgen.com

研究場所

    • Florida
      • Miami、Florida、アメリカ、33143
        • 募集
        • QPS Miami
    • LDS
      • Leeds、LDS、イギリス、LS11 9EH
        • 募集
        • Fortrea Clinical Research Unit Limited - Leeds

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~60年 (大人)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Healthy adults, male or female, 18 to 60 years of age.
  • Able and willing to provide written informed consent before any study procedures.
  • Body weight between 45.0 kg and 95.0 kg (inclusive).
  • Women must not be able to become pregnant (for example, postmenopausal or permanently sterile, as defined by the protocol).
  • Men who can father a child must agree to use the required contraception during the study and for 3 months after the study drug dose.
  • Willing and able to take daily calcium (500 to 2,000 mg elemental calcium) and vitamin D (at least 400 IU) supplements from Day 1 through the end of the study.

Exclusion Criteria:

  • Any clinically significant medical condition or abnormal finding that, in the opinion of the study doctor, could make participation unsafe or interfere with the study or its results.
  • Clinically significant abnormalities on medical history, physical examination, vital signs, electrocardiogram (ECG), or laboratory tests, including suspected Gilbert syndrome.
  • History or current signs or symptoms of significant cardiovascular disease, including heart attack, heart failure, congenital heart disease, cardiomyopathy, valve disease, angina, coronary revascularization, stroke, transient ischemic attack, or peripheral revascularization.
  • Clinically significant abnormal heart rhythm or conduction disorder, including clinically significant ECG abnormalities.
  • QT interval corrected for heart rate (QTcF) greater than 450 milliseconds for men or greater than 470 milliseconds for women, or a history of long QT syndrome.
  • Second- or third-degree atrioventricular (AV) block.
  • Systolic blood pressure greater than 140 millimeters of mercury (mmHg) or less than 90 mmHg, diastolic blood pressure greater than 90 mmHg or less than 50 mmHg, or pulse rate greater than 100 beats per minute or less than 40 beats per minute at screening or check-in.
  • Deep vein thrombosis or pulmonary embolism within 3 months before screening.
  • History of osteoporosis, vertebral fracture, or a fragility fracture of the wrist, upper arm, hip, or pelvis after 50 years of age.
  • History of metabolic bone disease, including conditions such as Paget disease, osteomalacia, osteogenesis imperfecta, osteopetrosis, sclerosteosis, ankylosing spondylitis, rheumatoid arthritis, Cushing disease, hyperprolactinemia, or malabsorption syndrome.
  • History of osteonecrosis of the jaw.
  • Bone fracture within 6 months before screening.
  • Vitamin D level below 20 nanograms per milliliter (ng/mL) at screening (participants may be treated and retested before enrollment).
  • Current hyperparathyroidism or hypoparathyroidism.
  • Kidney function below study requirements (estimated glomerular filtration rate less than 60 mL/min/1.73 m^2).
  • Low or high blood calcium levels that do not meet study requirements.
  • Liver blood test results (alanine aminotransferase [ALT] or aspartate aminotransferase [AST]) above the normal range.
  • History of hyperthyroidism or hypothyroidism unless on stable treatment for at least 6 months with normal thyroid function tests.
  • History of hearing loss caused by excessive bone growth compressing the eighth cranial nerve.
  • Positive test for human immunodeficiency virus (HIV).
  • Active hepatitis B or hepatitis C infection.
  • Cancer within the past 5 years, except non-melanoma skin cancer or cervical or breast ductal carcinoma in situ.
  • History of solid organ or bone marrow transplantation.
  • History of allergy or hypersensitivity to romosozumab, its ingredients, other biologic medicines, or medicines derived from mammalian cells.
  • Previous use of medications affecting bone metabolism that are not allowed by the protocol, including:
  • Any intravenous or oral bisphosphonate.
  • Fluoride for osteoporosis within 24 months before screening.
  • Denosumab or cathepsin K inhibitors within 18 months before screening.
  • Parathyroid hormone or strontium within 12 months before screening.
  • Calcitonin, selective estrogen receptor modulators, or tibolone within 3 months before screening.
  • Systemic corticosteroids (5 mg or more prednisone equivalent daily for more than 10 days) within 3 months before screening.
  • Use of prescription or over-the-counter medications within 30 days or 5 half-lives (whichever is longer) before check-in, unless approved by the study doctor. Acetaminophen up to 2 g/day is permitted. Stable hormone replacement therapy is allowed if unchanged for at least 3 months before dosing and throughout the study.
  • Use of herbal medicines, vitamins (other than study-required calcium and vitamin D), or dietary supplements within 30 days before enrollment unless approved by the study doctor.
  • Currently participating in another clinical study, receiving another investigational treatment, or participation in another investigational drug or device study within the previous 90 days or 5 half-lives (whichever is longer).
  • Previous participation in this study or previous exposure to a sclerostin antibody.
  • History of alcohol abuse or regular alcohol intake greater than 14 units per week within the year before check-in.
  • Alcohol use within 48 hours before check-in or unwillingness to comply with study alcohol restrictions.
  • Positive alcohol test at check-in.
  • Positive drug screen for illicit drugs, including cannabis, at screening or check-in.
  • History of illicit drug use within 6 months before screening.
  • Unwilling to avoid illicit drug use, including cannabis, throughout the study.
  • Smoking more than 10 cigarettes per day or equivalent nicotine use within 1 month before check-in, or unwillingness to comply with study tobacco restrictions.
  • Consumption of foods or drinks containing poppy seeds within 7 days before check-in.
  • Positive pregnancy test at screening or check-in.
  • Pregnant, breastfeeding, or planning to breastfeed during the study or within 3 months after receiving the study drug.
  • Receipt of blood products within 2 months before check-in.
  • Blood donation within 3 months before screening, plasma donation within 2 weeks before screening, or platelet donation within 6 weeks before screening.
  • Poor veins that would make repeated blood sampling difficult.
  • Any other reason that, in the opinion of the study doctor, would make participation unsafe or inappropriate.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:Romosozumab Test Arm

Participants will receive a single SC injection of romosozumab (test) administered using a PFS.

Romosozumab will be administered via SC injection using a PFS.

他の名前:
  • AMG785
  • Evenity®
アクティブコンパレータ:Romosozumab Reference Arm

Participants will receive two SC injections of romosozumab (reference) administered using a PFS.

Romosozumab will be administered via SC injection using a PFS.

他の名前:
  • AMG785
  • Evenity®

この研究は何を測定していますか?

主要な結果の測定

結果測定
時間枠
Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of romosozumab
時間枠:Up to Day 85
Up to Day 85
Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) of romosozumab
時間枠:Up to Day 85
Up to Day 85
Maximum Observed Serum Concentration (Cmax) of romosozumab
時間枠:Up to Day 85
Up to Day 85

二次結果の測定

結果測定
時間枠
Number of Participants Who Experienced Treatment-Emergent Adverse Events and Serious Adverse Events
時間枠:Up to Day 85
Up to Day 85
Number of Participants Who Developed Anti-romosozumab Antibodies
時間枠:Up to Day 85
Up to Day 85

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • スタディディレクター:MD、Amgen

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年9月22日

一次修了 (推定)

2027年1月14日

研究の完了 (推定)

2027年1月14日

試験登録日

最初に提出

2026年9月4日

QC基準を満たした最初の提出物

2026年9月4日

最初の投稿 (実際)

2026年9月10日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月13日

QC基準を満たした最後の更新が送信されました

2026年10月12日

最終確認日

2026年10月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 20250008

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?

はい

IPD プランの説明

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD 共有時間枠

Data sharing requests relating to this trial will be considered beginning 18 months after the trial has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this trial.

IPD 共有アクセス基準

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen trial/trials in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

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

はい

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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