A Phase 1 Study of Single-Dose BW-50218 in Healthy Chinese Participants
23 juin 2026 mis à jour par: 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
Aperçu de l'étude
Statut
Actif, ne recrute pas
Les conditions
Intervention / Traitement
Description détaillée
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of A Single Dose of BW-50218 in Healthy Chinese Participants
Type d'étude
Interventionnel
Inscription (Estimé)
24
Phase
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
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Shanghai, Chine
- Argo Investigative Site
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Oui
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur placebo: Placebo salin
Dose unique de solution saline placebo
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Solution injectable
|
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Expérimental: BW-50218 Dose1
Single dose of BW-50218 injection (Dose 1)
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Solution injectable
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Expérimental: BW-50218 Dose 2
Single dose of BW-50218 injection (Dose 2)
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Solution injectable
|
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Expérimental: BW-50218 Dose 3
Single dose of BW-50218 injection (Dose 3)
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Solution injectable
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAES)
Délai: 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).
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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.
Délai: 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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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.
Délai: 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.
Délai: 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)
|
|
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.
Délai: 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.
Délai: 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.
Délai: 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.
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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
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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).
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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.
Délai: 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)
|
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Change from Baseline in Physical Examination Findings
Délai: 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)
|
|
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.
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Concentration plasmatique maximale observée (Cmax)
Délai: De la pré-dose jusqu'au jour 8
|
Évaluation de la concentration plasmatique maximale du BW-50218.
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De la pré-dose jusqu'au jour 8
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Temps jusqu'à la concentration plasmatique maximale (Tmax)
Délai: De la pré-dose jusqu'au jour 8
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Évaluation du temps pour atteindre la concentration plasmatique maximale.
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De la pré-dose jusqu'au jour 8
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Area Under the Plasma Concentration-Time Curve (AUC)
Délai: 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)
Délai: From pre-dose up to Day 8
|
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)
Délai: 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)
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From pre-dose up to 24 hours post-dose
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Directeur d'études: Yuqiong Li, Shanghai Argo Biopharmaceutical Co., Ltd.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
18 mai 2026
Achèvement primaire (Estimé)
30 juin 2027
Achèvement de l'étude (Estimé)
30 avril 2028
Dates d'inscription aux études
Première soumission
13 avril 2026
Première soumission répondant aux critères de contrôle qualité
5 mai 2026
Première publication (Réel)
11 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
24 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
23 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- BW-50218-1002
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .