A Phase 1 Study of Single-Dose BW-50218 in Healthy Chinese Participants
2026年6月23日 更新者：Shanghai Argo Biopharmaceutical Co., Ltd.
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of A Single Dose of BW-50218 in Healthy Chinese Participants
A Phase 1 Study of Single-Dose BW-50218 in Healthy Chinese Participants
調査の概要
詳細な説明
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of A Single Dose of BW-50218 in Healthy Chinese Participants
研究の種類
介入
入学 (推定)
24
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。
研究場所
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Shanghai、中国
- Argo Investigative Site
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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
- 大人
健康ボランティアの受け入れ
はい
説明
Inclusion Criteria:
- Capable of providing written informed consent and complying with all study procedures for the duration of the study.
- Body weight > 50 kg for males and > 45 kg for females; body mass index (BMI) within a range considered appropriate for study participation by the investigator.
- Female participants must be non-pregnant, non-lactating, and either of non-childbearing potential or using highly effective contraception.
- Male participants with partners of childbearing potential must agree to use effective contraception.
Exclusion Criteria:
- Any clinically significant chronic medical condition or clinically significant abnormality in physical examination that, in the opinion of the Investigator, makes the participant unsuitable for participation in the study.
- Recent hospitalization or a significant acute medical event.
- History of cancer or any long-term medical condition that the study doctor considers clinically relevant.
- Clinical laboratory findings outside of range which are deemed clinically significant by the investigator at screening or Day -1.
- Positive test for hepatitis B, hepatitis C, or HIV.
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：処理
- 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
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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プラセボコンパレーター：生理食塩水プラセボ
生理食塩水プラセボの単回投与
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注射用溶液
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実験的：BW-50218 Dose1
Single dose of BW-50218 injection (Dose 1)
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注射用溶液
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実験的：BW-50218 Dose 2
Single dose of BW-50218 injection (Dose 2)
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注射用溶液
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実験的：BW-50218 Dose 3
Single dose of BW-50218 injection (Dose 3)
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注射用溶液
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAES)
時間枠：From baseline up to Day 360 (End of Study)
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Evaluation of the number of participants with treatment-emergent adverse events and serious adverse events.
The severity of AEs will be assessed and categorized according to the "Guidance for industry: Toxicity Grading Scale for Healthy Adultand Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" (FDA, 2007).
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From baseline up to Day 360 (End of Study)
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Hematology results (Platelets, 10^9/L) at each time point, including changes from baseline to Day 360 post dose will be summarized by treatment group.
時間枠：From baseline up to Day 360 (End of Study)
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The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline.
The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety.
Those values or changes in values that are identified as being clinically significant will be flagged.
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From baseline up to Day 360 (End of Study)
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Hematology results (concentration of Hemoglobin, g/L) at each time point, including changes from baseline to Day 360 post dose will be summarized by treatment group.
時間枠：From baseline up to Day 360 (End of Study)
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The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline.
The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety.
Those values or changes in values that are identified as being clinically significant will be flagged.
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From baseline up to Day 360 (End of Study)
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Chemistry results (Albumin, g/L) at each time point from baseline to Day 360 will be summarized bytreatment group.
時間枠：From baseline up to Day 360 (End of Study)
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The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline.
The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety.
Those values or changes in values that are identified as being clinically significant will be flagged.
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From baseline up to Day 360 (End of Study)
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Chemistry results (Alkaline Phosphatase, U/L; Alanine Aminotransferase, U/L; Aspartate Aminotransferase, U/L) at each time point from baseline to Day 360 will be summarized bytreatment group.
時間枠：From baseline up to Day 360 (End of Study)
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The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline.
The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety.
Those values or changes in values that are identified as being clinically significant will be flagged.
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From baseline up to Day 360 (End of Study)
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Chemistry results (Direct Bilirubin, umol/L) at each time point from baseline to Day 360 will be summarized bytreatment group.
時間枠：From baseline up to Day 360 (End of Study)
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The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline.
The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety.
Those values or changes in values that are identified as being clinically significant will be flagged.
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From baseline up to Day 360 (End of Study)
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Urinalysis results (Epithelial cells, crystals, casts, bilirubin) at each time point,including change from baseline to Day 360 post dose will be summarized in thetable by treatment group.
時間枠：From baseline up to Day 360 (End of Study)
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The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline.
The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety.
Those values or changes in values that are identified as being clinically significant will be fagged.
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From baseline up to Day 360 (End of Study)
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Vital signs (Blood pressures, millimeters of mercury) changes from Baselinevalues to Day 360 post dose will be summarized in the table by treatment group
時間枠：From baseline up to Day 360 (End of Study)
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Abnormal physical examination findings will be listed.
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From baseline up to Day 360 (End of Study)
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Vital signs (Heart rate, beats per minute) changes from Baseline values to Day 360 post dose will be summarized in the table by treatment group.
時間枠：From baseline up to Day 360 (End of Study)
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Abnormal physical examination findings will be listed.
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From baseline up to Day 360 (End of Study)
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Vital signs (Respiratory rate, times per minute) changes from Baseline values to Day 360 post dose will be summarized in the table by treatment group.
時間枠：From baseline up to Day 360 (End of Study)
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Abnormal physical examination findings will be listed.
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From baseline up to Day 360 (End of Study)
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Vital signs (Temperature,degrees Celsius) changes from Baseline values to Day 360 post dose will be summarized in the table by treatment group.
時間枠：From baseline up to Day 360 (End of Study)
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Abnormal physical examination findings will be listed.
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From baseline up to Day 360 (End of Study)
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Changes in ECG (PR Interval, msec; QRs Duration, msec;QT interval, msec; RR interval, msec; QTcF Interval, msec; ) from Baseline to Day 360 post-dose will be summarized.
時間枠：From baseline up to Day 360 (End of Study)
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12-lead ECGs will be summarized by visit and by treatment group, along with the changes from baseline.The summary of overall interpretation findings table presented counts and percentages for the reported results at Baseline and Day 360/time point.
Result categories were ordered as "Normal", "Abnormal Not Clinically Significant (NCS)" and "Abnormal Clinically Significant (CS)"(categorical descriptive analysis).
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From baseline up to Day 360 (End of Study)
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Changes in ECG (Mean heart rate, bpm ) from Baseline to Day 360 post-dose will be summarized.
時間枠：From baseline up to Day 360 (End of Study)
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12-lead ECGs will be summarized by visit and by treatment group, along with the changes from baseline.The summary of overall interpretation findings table presented counts and percentages for the reported results at Baseline and Day 360/time point.
Result categories were ordered as "Normal", "Abnormal Not Clinically Significant (NCS)" and "Abnormal Clinically Significant (CS)"(categorical descriptive analysis).
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From baseline up to Day 360 (End of Study)
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Change from Baseline in Physical Examination Findings
時間枠：From baseline up to Day 360 (End of Study)
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Assessment of clinically significant changes in physical examination findings
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From baseline up to Day 360 (End of Study)
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Hematology results (Red blood cell count, 10^12/L) at each time point, including changes from baseline to Day 360 post dose will be summarized by treatment group.
時間枠：From baseline up to Day 360 (End of Study)
|
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline.
The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety.
Those values or changes in values that are identified as being clinically significant will be flagged.
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From baseline up to Day 360 (End of Study)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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最高血漿中濃度（Cmax）
時間枠：投与前から8日目まで
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BW-50218の最高血漿濃度の評価。
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投与前から8日目まで
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最高血漿濃度到達時間（Tmax）
時間枠：投与前からDay 8まで
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最大血漿濃度到達時間の評価
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投与前からDay 8まで
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Area Under the Plasma Concentration-Time Curve (AUC)
時間枠：From pre-dose up to Day 8
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Evaluation of AUc from time zero to 24 hours (AUC0-24), to 48 hours (AUC0-48), and to infinity (AUC0-inf)
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From pre-dose up to Day 8
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Terminal Elimination Half-Life (t1/2)
時間枠：From pre-dose up to Day 8
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Evaluation of the elimination half-life of BW-50218
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From pre-dose up to Day 8
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Urine Pharmacokinetic Parameters (Renal Clearance, CLr)
時間枠：From pre-dose up to 24 hours post-dose
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Renal clearance calculated as CLr = CAe/Plasma AUC 0-24.
Ae=cumulative amount excreted in urine (mg).
AUC 0-24 = Area under the plasma concentration - time curve from 0 to 24 hours(e.g.mg*h/mL)
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From pre-dose up to 24 hours post-dose
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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。
捜査官
- スタディディレクター：Yuqiong Li、Shanghai Argo Biopharmaceutical Co., Ltd.
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5月18日
一次修了 (推定)
2027年6月30日
研究の完了 (推定)
2028年4月30日
試験登録日
最初に提出
2026年4月13日
QC基準を満たした最初の提出物
2026年5月5日
最初の投稿 (実際)
2026年5月11日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月24日
QC基準を満たした最後の更新が送信されました
2026年6月23日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
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?
いいえ
IPD プランの説明
A decision regarding sharing of de-identified IPD will be made by the Sponsor after study completion and will consider scientific merit, participant privacy, and regulatory requirements.
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
いいえ
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。