Étude comparative de phase 1 évaluant la pharmacocinétique, l'immunogénicité, la sécurité et la tolérabilité de Bmab3000 et de Herceptin Hylecta<sup>®</sup> après une injection sous-cutanée unique de 600 mg chez des volontaires masculins en bonne santé
Une étude comparative de phase 1, randomisée, en double aveugle, à deux bras, en parallèle, évaluant la pharmacocinétique, l'immunogénicité, la sécurité et la tolérabilité de Bmab3000 et de Herceptin Hylecta® après une dose unique de 600 mg en injection sous-cutanée chez des volontaires masculins sains
This phase I study is to compare the pharmacokinetics (PK), immunogenicity, safety, and tolerability of Bmab3000 (test) and Herceptin Hylecta (reference) after a single subcutaneous (s.c.) dose in healthy male volunteers.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This is a Phase 1, randomized, double-blind, two-arm, parallel-group trial comparing the pharmacokinetics (PK), immunogenicity, safety, and tolerability of Bmab3000 (test) and Herceptin Hylecta (reference) after a single subcutaneous (s.c.) dose.
A total of 150 healthy male participants (75 per arm) will be enrolled to ensure 138 evaluable subjects. Participants will be randomized in 1:1 using stratified block randomization based on baseline body weight (≥50-≤75 kg and >75-≤100 kg).
Each participant will be involved in the study for approximately four months, which includes one screening visit, a 3-night inpatient stay, and 16 scheduled outpatient follow-up visits. Participants will attend a screening visit (Day -28 to Day -1) to confirm eligibility. This will include obtaining informed consent, medical history, physical examination, vital signs, biometric measurements, ECG, echocardiogram, and blood and urine tests, as well as drug and alcohol screening. Eligible participants will be admitted to the study site on Day -1 for pre-dose assessments to confirm continued eligibility. On Day 1, participants will receive a single subcutaneous injection of either Bmab3000 or Herceptin Hylecta. During the inpatient stay (Days -1 to 3), participants will undergo continuous safety monitoring, including regular vital signs, ECGs, injection site checks, and blood sampling for pharmacokinetic, safety, and immunogenicity assessments. After discharge, participants will return for outpatient visits till Day 85 for continued safety monitoring, blood sampling for pharmacokinetic and immunogenicity analyses, and ECGs and vital sign assessments. The final visit on Day 91 will include a full physical examination, echocardiogram, ECG and blood sampling for pharmacokinetic & immunogenicity analyses and final laboratory evaluations.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Main Building: 264 Antigua Street,
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Christchurch, Main Building: 264 Antigua Street,, Nouvelle-Zélande
- New Zealand Clinical Research (NZCR)
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Healthy male volunteers aged between 18 to 65 years; both inclusive.
- Body weight ≥50 kg and ≤100 kg with body mass index (BMI) between 18.5 and 30 kg/m2, both inclusive.
- Participants should have Left ventricular ejection fraction (LVEF) ≥55%.
- Male participants must be using an acceptable method of contraception for the entire duration of the trial, and for at least three months after the trial drug administration. Participants must refrain from fathering a child or donating sperm in the next three months following the last trial drug administration or undergoing vasectomy.
- All non-prescription medications must have been discontinued at least 14 days prior to dosing.
- All non-topical prescription medications must have been stopped at least 30 days prior to admission to the clinical research center.
- Absence of significant findings in the vital signs, 12 lead ECG, and clinical laboratory tests of blood and urine.
- Willing and able to sign the informed consent form (ICF).
Exclusion Criteria:
- History of previous exposure to trastuzumab.
- Presence of clinically significant medical history and clinically significant findings in the physical examination.
- Allergy or hypersensitivity to trastuzumab, other recombinant human or humanized antibodies, other related products, or any excipients/ ingredients (e.g. hyaluronidase).
- Sick sinus syndrome or known long QT syndrome (QTcF >450 msec).
- Pronounced sinus bradycardia (<40 bpm), even if elicited by sport.
- History of relevant drug and/or food allergies.
- Positive urine drug and breath alcohol screen.
- Consumption of any foods containing poppy seeds within 48 hours (2 days) prior to screening/admission to the clinical research center.
- Positive screen for hepatitis B surface antigen (HBsAg), anti-hepatitis virus (HCV) antibodies, anti-human immunodeficiency virus (HIV) 1 and 2 antibodies.
- Donation or loss of blood prior to drug administration.
Plan d'étude
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 |
|---|---|
|
Expérimental: Bmab3000
Single s.c. dose of Bmab3000 containing 600 mg of trastuzumab and 10,000 units of hyaluronidase in 5 mL |
Single s.c. dose of Herceptin Hylecta containing 600 mg of trastuzumab and 10,000 units of hyaluronidase in 5 mL |
|
Comparateur actif: Herceptin Hylecta®
Single s.c. dose of Herceptin Hylecta containing 600 mg of trastuzumab and 10,000 units of hyaluronidase in 5 mL |
Single s.c. dose of Bmab3000 containing 600 mg of trastuzumab and 10,000 units of hyaluronidase in 5 mL |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Cmax
Délai: Day 1 to Day 91
|
Maximum observed concentration (Cmax) of drug Bmab 3000 |
Day 1 to Day 91
|
|
AUCo-∞
Délai: Day 1 to Day 91
|
Comparison of area under the concentration-time curve from time 0 to infinity (AUC0-inf) |
Day 1 to Day 91
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
AUCo-t
Délai: Day 1 to Day 91
|
Area Under the serum Concentration versus time curve from time 0 to the last sampling time at which concentrations were at or above the limit of quantification |
Day 1 to Day 91
|
|
Tmax
Délai: Day 1 to Day 91
|
Time to maximum observed concentration |
Day 1 to Day 91
|
|
Vd/F
Délai: Day 1 to Day 91
|
Volume of distribution |
Day 1 to Day 91
|
|
Cl/F
Délai: Day 1 to Day 91
|
drug clearance |
Day 1 to Day 91
|
|
t1/2
Délai: Day 1 to Day 91
|
Apparent terminal elimination half-life |
Day 1 to Day 91
|
|
AUC% extrapolation
Délai: Day 1 to Day 91
|
% of the AUC that has been derived after extrapolation |
Day 1 to Day 91
|
|
λz
Délai: Day 1 to Day 91
|
Elimination rate constant |
Day 1 to Day 91
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Safety_ Adverse Reactions
Délai: Baseline to Day 91
|
Adverse Events and Adverse Reactions during the Treatment Period |
Baseline to Day 91
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Safety_ Injection-site Reactions
Délai: Day 1 to Day 91
|
Injection-site Reactions |
Day 1 to Day 91
|
|
Immunogenicity
Délai: Day 1 to Day 91
|
Developing Antidrug Antibodies |
Day 1 to Day 91
|
|
Immunogenicity
Délai: Day 1 to Day 91
|
Developing Neutralizing Antibodies |
Day 1 to Day 91
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Dr Cory Sellwood, MBBS, New Zealand Clinical Research (NZCR) Main Building: 264 Antigua Street, Christchurch, New Zealand
- Chercheur principal: Dr Leanne Barnett, MBBS, New Zealand Clinical Research (NZCR) Main Building: 3 Ferncroft Street, Grafton, Auckland, New Zealand
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- BIO-TRASTU-103
- U1111-1329-7865 (Autre identifiant: World Health Organization (WHO))
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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