- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07612813
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
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 1
Contatti e Sedi
Contatto studio
- Nome: AstraZeneca Clinical Study Information Center
- Numero di telefono: 1-877-240-9479
- Email: information.center@astrazeneca.com
Luoghi di studio
-
-
-
Sumida-ku, Giappone, 130-0004
- Research Site
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
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:
- Known hypersensitivity to any component of the study intervention.
- Previous hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of mAbs.
- Clinically significant bleeding disorder or prior history of significant bleeding or bruising following intramuscular injections or venipuncture.
- AST or ALT above 1.5 × ULN at screening.
- Estimated glomerular filtration rate < 90 mL/min/1.73 m2.
- Hemoglobin or platelet count below the lower limit of normal at screening.
- White blood cell counts outside normal reference ranges.
- History of malignancy other than treated non-melanoma skin cancers or locally treated cervical cancer in the previous 5 years.
- Any clinically significant abnormalities on 12-lead ECG at screening,
- Acute (time-limited) illness, including fever ≥ 38 °C (100.4 °F), one day prior to or on the day of planned dosing.
- Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy.
- Any condition that has the potential to increase clearance of the study intervention.
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.
- Absence of suitable veins for blood sampling and administration of study intervention.
- Any other condition that would compromise the safety of the participants.
- Any condition that might interfere with evaluation of the study intervention or interpretation of participant safety or study results.
- 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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Cohort 1 (AZD7760 Dose A)
Participants receive an IV infusion of AZD7760 Dose A on Day 1.
|
Participants will receive AZD7760 via IV infusion.
|
|
Sperimentale: Cohort 2 (AZD7760 Dose B)
Participants receive an IV infusion of AZD7760 Dose B on Day 1.
|
Participants will receive AZD7760 via IV infusion.
|
|
Comparatore placebo: Pooled Placebo
Participants receive an IV infusion of matching placebo on Day 1.
|
Participants will receive matching placebo via IV infusion.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Occurrence of Adverse Events (AEs)
Lasso di tempo: Day 1 to Day 181
|
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
|
|
Occurrence of Medically-attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
Lasso di tempo: Day 1 to Day 361
|
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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Maximum observed serum (peak) drug concentration (Cmax)
Lasso di tempo: Day 1 to Day 361
|
To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.
|
Day 1 to Day 361
|
|
Time to reach peak or maximum observed concentration following drug administration (tmax)
Lasso di tempo: Day 1 to Day 361
|
To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.
|
Day 1 to Day 361
|
|
Terminal elimination half-life (t½λz)
Lasso di tempo: Day 1 to Day 361
|
To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.
|
Day 1 to Day 361
|
|
Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast)
Lasso di tempo: Day 1 to Day 361
|
To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.
|
Day 1 to Day 361
|
|
Area under the concentration-time curve from time 0 to infinity (AUCinf)
Lasso di tempo: Day 1 to Day 361
|
To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.
|
Day 1 to Day 361
|
|
Volume of distribution at steady state (Vss)
Lasso di tempo: Day 1 to Day 361
|
To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.
|
Day 1 to Day 361
|
|
Volume of distribution based on the terminal phase (Vz)
Lasso di tempo: Day 1 to Day 361
|
To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.
|
Day 1 to Day 361
|
|
Incidence of Anti-drug antibody (ADA)
Lasso di tempo: Day 1 to Day 361
|
To evaluate ADA responses to AZD7760 in serum of healthy Japanese adult participants
|
Day 1 to Day 361
|
Collaboratori e investigatori
Sponsor
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- D7480C00003
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Periodo di condivisione IPD
Criteri di accesso alla condivisione IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Infezione del flusso sanguigno da Staphylococcus Aureus
-
University Hospital TuebingenReclutamento
-
Centre Hospitalier Universitaire de Saint EtienneCompletato
-
University of SheffieldRajarata University, Sri LankaSconosciuto
-
NovaDigm Therapeutics, Inc.Uniformed Services University of the Health Sciences; Infectious Diseases Clinical...CompletatoStaphylococcus aureusStati Uniti
-
West Virginia UniversityIscrizione su invitoBatteriemia da Staphylococcus AureusStati Uniti
-
Intermountain Health Care, Inc.Non ancora reclutamentoBatteriemia da Staphylococcus AureusStati Uniti
-
Region SkaneReclutamentoBatteriemia stafilococcica | Infezione da Staphylococcus (S.) Aureus | Infezioni del flusso sanguigno da Staphylococcus Aureus (BSI; batteriemia) | Batteriemia da Staphylococcus AureusSvezia
-
University of MelbourneKing's College London; Radboud University Medical Center; Rambam Health Care Campus e altri collaboratoriReclutamentoBatteriemia da Staphylococcus AureusAustralia, Stati Uniti, Nuova Zelanda, Canada, Regno Unito, Singapore, Svezia, Olanda, Francia, Germania, Israele, Sud Africa, Giappone
-
Hospices Civils de LyonCompletato
-
Northwestern UniversityCompletatoPortatori nasali di Staphylococcus AureusStati Uniti
Prove cliniche su AZD7760
-
AstraZenecaParexelReclutamento