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A Phase 1 Study of Single-Dose BW-50218 in Healthy Chinese Participants

2026년 6월 23일 업데이트: 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

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

상세 설명

A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of A Single Dose of BW-50218 in Healthy Chinese Participants

연구 유형

중재적

등록 (추정된)

24

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 중국
      • Shanghai, 중국
        • Argo Investigative Site

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

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예

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: 생리식염수 위약
단일 용량의 식염수 플라시보
의약품: Saline (0.9% NaCl)
주사용 용액
실험적: BW-50218 Dose1
Single dose of BW-50218 injection (Dose 1)
의약품: BW-50218 인젝션
주사용 용액
실험적: BW-50218 Dose 2
Single dose of BW-50218 injection (Dose 2)
의약품: BW-50218 인젝션
주사용 용액
실험적: BW-50218 Dose 3
Single dose of BW-50218 injection (Dose 3)
의약품: BW-50218 인젝션
주사용 용액

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAES)
기간: From baseline up to Day 360 (End of Study)
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).
From baseline up to Day 360 (End of Study)
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.
기간: 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.
From baseline up to Day 360 (End of Study)
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.
기간: 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.
From baseline up to Day 360 (End of Study)
Chemistry results (Albumin, g/L) at each time point from baseline to Day 360 will be summarized bytreatment group.
기간: 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.
From baseline up to Day 360 (End of Study)
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.
기간: 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.
From baseline up to Day 360 (End of Study)
Chemistry results (Direct Bilirubin, umol/L) at each time point from baseline to Day 360 will be summarized bytreatment group.
기간: 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.
From baseline up to Day 360 (End of Study)
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.
기간: 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 fagged.
From baseline up to Day 360 (End of Study)
Vital signs (Blood pressures, millimeters of mercury) changes from Baselinevalues to Day 360 post dose will be summarized in the table by treatment group
기간: From baseline up to Day 360 (End of Study)
Abnormal physical examination findings will be listed.
From baseline up to Day 360 (End of Study)
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.
기간: From baseline up to Day 360 (End of Study)
Abnormal physical examination findings will be listed.
From baseline up to Day 360 (End of Study)
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.
기간: From baseline up to Day 360 (End of Study)
Abnormal physical examination findings will be listed.
From baseline up to Day 360 (End of Study)
Vital signs (Temperature,degrees Celsius) changes from Baseline values to Day 360 post dose will be summarized in the table by treatment group.
기간: From baseline up to Day 360 (End of Study)
Abnormal physical examination findings will be listed.
From baseline up to Day 360 (End of Study)
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.
기간: From baseline up to Day 360 (End of Study)
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).
From baseline up to Day 360 (End of Study)
Changes in ECG (Mean heart rate, bpm ) from Baseline to Day 360 post-dose will be summarized.
기간: From baseline up to Day 360 (End of Study)
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).
From baseline up to Day 360 (End of Study)
Change from Baseline in Physical Examination Findings
기간: From baseline up to Day 360 (End of Study)
Assessment of clinically significant changes in physical examination findings
From baseline up to Day 360 (End of Study)
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.
기간: 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.
From baseline up to Day 360 (End of Study)

2차 결과 측정

결과 측정
측정값 설명
기간
최대 관찰 혈장 농도 (Cmax)
기간: 투여 전부터 8일차까지
BW-50218의 최대 혈장 농도 평가.
투여 전부터 8일차까지
최대 혈장 농도 도달 시간 (Tmax)
기간: 투여 전부터 8일차까지
최대 혈장 농도 도달 시간 평가.
투여 전부터 8일차까지
Area Under the Plasma Concentration-Time Curve (AUC)
기간: From pre-dose up to Day 8
Evaluation of AUc from time zero to 24 hours (AUC0-24), to 48 hours (AUC0-48), and to infinity (AUC0-inf)
From pre-dose up to Day 8
Terminal Elimination Half-Life (t1/2)
기간: From pre-dose up to Day 8
Evaluation of the elimination half-life of BW-50218
From pre-dose up to Day 8
Urine Pharmacokinetic Parameters (Renal Clearance, CLr)
기간: From pre-dose up to 24 hours post-dose
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)
From pre-dose up to 24 hours post-dose

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Shanghai Argo Biopharmaceutical Co., Ltd.

수사관

  • 연구 책임자: Yuqiong Li, Shanghai Argo Biopharmaceutical Co., Ltd.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 5월 18일

기본 완료 (추정된)

2027년 6월 30일

연구 완료 (추정된)

2028년 4월 30일

연구 등록 날짜

최초 제출

2026년 4월 13일

QC 기준을 충족하는 최초 제출

2026년 5월 5일

처음 게시됨 (실제)

2026년 5월 11일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 24일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 23일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • BW-50218-1002

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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