A Phase 1 Study of Single-Dose BW-50218 in Healthy Chinese Participants
23. juni 2026 oppdatert av: 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
Studieoversikt
Status
Aktiv, ikke rekrutterende
Forhold
Intervensjon / Behandling
Detaljert 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
Studietype
Intervensjonell
Registrering (Antatt)
24
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Shanghai, Kina
- Argo Investigative Site
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske 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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: Salin Placebo
Enkeltdose av Salin Placebo
|
Løsning for injeksjon
|
|
Eksperimentell: BW-50218 Dose1
Single dose of BW-50218 injection (Dose 1)
|
Løsning til injeksjon
|
|
Eksperimentell: BW-50218 Dose 2
Single dose of BW-50218 injection (Dose 2)
|
Løsning til injeksjon
|
|
Eksperimentell: BW-50218 Dose 3
Single dose of BW-50218 injection (Dose 3)
|
Løsning til injeksjon
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Maksimal observert plasmakonsentrasjon (Cmax)
Tidsramme: Fra før dosering opp til dag 8
|
Evaluering av den maksimale plasmakonsentrasjonen av BW-50218.
|
Fra før dosering opp til dag 8
|
|
Tid til maksimal plasmakonsentrasjon (Tmax)
Tidsramme: Fra før dose opp til dag 8
|
Evaluering av tiden for å oppnå maksimal plasmakonsentrasjon.
|
Fra før dose opp 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studieleder: Yuqiong Li, Shanghai Argo Biopharmaceutical Co., Ltd.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
18. mai 2026
Primær fullføring (Antatt)
30. juni 2027
Studiet fullført (Antatt)
30. april 2028
Datoer for studieregistrering
Først innsendt
13. april 2026
Først innsendt som oppfylte QC-kriteriene
5. mai 2026
Først lagt ut (Faktiske)
11. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BW-50218-1002
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .