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

2. juni 2026 opdateret af: 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

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

24

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
      • Shanghai, Kina
        • Rekruttering
        • Argo Investigative Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Salinoplacebo
Enkelt dosis af Saline Placebo
Medicin: Saline (0,9% NaCl)
Injektionsopløsning
Eksperimentel: BW-50218 Dose1
Single dose of BW-50218 injection (Dose 1)
Medicin: BW-50218 Injektion
Injektionsvæske, opløsning
Eksperimentel: BW-50218 Dose 2
Single dose of BW-50218 injection (Dose 2)
Medicin: BW-50218 Injektion
Injektionsvæske, opløsning
Eksperimentel: BW-50218 Dose 3
Single dose of BW-50218 injection (Dose 3)
Medicin: BW-50218 Injektion
Injektionsvæske, opløsning

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAES)
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maksimal observeret plasmakoncentration (Cmax)
Tidsramme: Fra før dosering op til dag 8
Evaluering af den maksimale plasmakoncentration af BW-50218.
Fra før dosering op til dag 8
Tid til Maksimal Plasmakoncentration (Tmax)
Tidsramme: Fra før dosering til dag 8
Evaluering af tiden til at nå den maksimale plasmakoncentration.
Fra før dosering til dag 8
Area Under the Plasma Concentration-Time Curve (AUC)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Shanghai Argo Biopharmaceutical Co., Ltd.

Efterforskere

  • Studieleder: Yuqiong Li, Shanghai Argo Biopharmaceutical Co., Ltd.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

18. maj 2026

Primær færdiggørelse (Anslået)

30. juni 2027

Studieafslutning (Anslået)

30. april 2028

Datoer for studieregistrering

Først indsendt

13. april 2026

Først indsendt, der opfyldte QC-kriterier

5. maj 2026

Først opslået (Faktiske)

11. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BW-50218-1002

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Undersøgelse af sunde deltagere

Kliniske forsøg med BW-50218 Injektion

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Sponsorer og samarbejdspartnere

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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