A Study to Evaluate the Safety and Pharmacokinetics of AZD7760 in Healthy Japanese Adults
A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of AZD7760 in Healthy Japanese Adult Participants
The purpose of this study is to evaluate the safety and PK of AZD7760 when given as an intravenous (IV) infusion to healthy Japanese adult participants.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This is a Phase I, randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety and PK of AZD7760, a mAb combination of suvratoxumab (labeled as MEDI4893) and AZD7745, in healthy Japanese adults. Two dosages of AZD7760 each administered as a single IV dose, will be assessed.
Study details include:
- A Screening Period of up to 28 days.
- A Dosing Period of 3 days, in which a single IV infusion will be given on Day 1.
- A Follow-up Period of 12 months from the time of administration of the study intervention.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Sumida-ku, Japon, 130-0004
- Research Site
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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:
- Body weight ≥ 45 kg and ≤ 110 kg and BMI within the range of ≥ 18.0 to ≤ 30.0 kg/m2 (inclusive) at screening.
- Healthy Japanese participants with no clinically significant concomitant diseases or medications.
Exclusion Criteria:
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Known hypersensitivity to any component of the study intervention.
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Previous hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of mAbs.
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Clinically significant bleeding disorder or prior history of significant bleeding or bruising following intramuscular injections or venipuncture.
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AST or ALT above 1.5 × ULN at screening.
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Estimated glomerular filtration rate < 90 mL/min/1.73 m2.
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Hemoglobin or platelet count below the lower limit of normal at screening.
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White blood cell counts outside normal reference ranges.
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History of malignancy other than treated non-melanoma skin cancers or locally treated cervical cancer in the previous 5 years.
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Any clinically significant abnormalities on 12-lead ECG at screening,
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Acute (time-limited) illness, including fever ≥ 38 °C (100.4 °F), one day prior to or on the day of planned dosing.
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Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy.
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Any condition that has the potential to increase clearance of the study intervention.
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Blood donation or collection as follows:
- 400 mL whole blood donation within 12 weeks (males) or 16 weeks (females) prior to study drug administration.
- 200 mL whole blood donation within 4 weeks prior to study drug administration.
- Apheresis donation within 2 weeks prior to study drug administration.
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Absence of suitable veins for blood sampling and administration of study intervention.
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Any other condition that would compromise the safety of the participants.
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Any condition that might interfere with evaluation of the study intervention or interpretation of participant safety or study results.
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Any laboratory value in the screening panel that, in the opinion of the investigator, is clinically significant or might confound analysis of study results. Testing may be repeated once at the investigator's discretion.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Cohort 1 (AZD7760 Dose A)
Participants receive an IV infusion of AZD7760 Dose A on Day 1. |
Participants will receive AZD7760 via IV infusion. |
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Expérimental: Cohort 2 (AZD7760 Dose B)
Participants receive an IV infusion of AZD7760 Dose B on Day 1. |
Participants will receive AZD7760 via IV infusion. |
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Comparateur placebo: Pooled Placebo
Participants receive an IV infusion of matching placebo on Day 1. |
Participants will receive matching placebo via IV infusion. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Occurrence of Adverse Events (AEs)
Délai: Day 1 to Day 181
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To evaluate the safety of AZD7760 administered as a single IV Dose A or Dose B in healthy Japanese adult participants. |
Day 1 to Day 181
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Occurrence of Medically-attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
Délai: Day 1 to Day 361
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To evaluate the safety of AZD7760 administered as a single IV Dose A or Dose B in healthy Japanese adult participants. |
Day 1 to Day 361
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Maximum observed serum (peak) drug concentration (Cmax)
Délai: Day 1 to Day 361
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To characterize the PK of AZD7760 in serum of healthy Japanese adult participants. |
Day 1 to Day 361
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Time to reach peak or maximum observed concentration following drug administration (tmax)
Délai: Day 1 to Day 361
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To characterize the PK of AZD7760 in serum of healthy Japanese adult participants. |
Day 1 to Day 361
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Terminal elimination half-life (t½λz)
Délai: Day 1 to Day 361
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To characterize the PK of AZD7760 in serum of healthy Japanese adult participants. |
Day 1 to Day 361
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Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast)
Délai: Day 1 to Day 361
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To characterize the PK of AZD7760 in serum of healthy Japanese adult participants. |
Day 1 to Day 361
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Area under the concentration-time curve from time 0 to infinity (AUCinf)
Délai: Day 1 to Day 361
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To characterize the PK of AZD7760 in serum of healthy Japanese adult participants. |
Day 1 to Day 361
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Volume of distribution at steady state (Vss)
Délai: Day 1 to Day 361
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To characterize the PK of AZD7760 in serum of healthy Japanese adult participants. |
Day 1 to Day 361
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Volume of distribution based on the terminal phase (Vz)
Délai: Day 1 to Day 361
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To characterize the PK of AZD7760 in serum of healthy Japanese adult participants. |
Day 1 to Day 361
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Incidence of Anti-drug antibody (ADA)
Délai: Day 1 to Day 361
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To evaluate ADA responses to AZD7760 in serum of healthy Japanese adult participants |
Day 1 to Day 361
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
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
- D7480C00003
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. ''Yes", indicates that AZ is accepting requests for IPD, but this does not mean all requests will be approved.
Délai de partage IPD
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Critères d'accès au partage IPD
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Informations sur les médicaments et les dispositifs, documents d'étude
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