Study of Safety and PK of AZD0543 in Healthy Adults
A Phase I, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Pharmacokinetics of AZD0543 in Healthy Adults
The purpose of this study is to assess the safety and PK of AZD0543 compared to placebo in healthy adults 18 to 55 years of age. AZD0543 or placebo will be administered as single IM or IV dose. The study duration will be approximately 12 months for each participant following administration of IMP.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
A phase 1, randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of AZD0543 in healthy adults 18-55 years of age. 144 participants will be randomized to receive either one of 3 dose levels of AZD0543 or a placebo comparator of the same volume. AZD0543 or placebo will be administered as a single dose on Day 1 via intramuscular (IM) injection or intravenous (IV) infusion. Participants will be followed for approximately 1 year.
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
-
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California
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Los Alamitos, California, Stati Uniti, 90720
- Reclutamento
- Research Site
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Florida
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South Miami, Florida, Stati Uniti, 33143
- Reclutamento
- Research Site
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Key Inclusion Criteria:
- Age 18 to 55 years
- Body weight ≥ 45 kg and ≤ 110 kg and BMI within the range ≥ 18.0 kg/m2 to ≤ 30 kg/m2
Key Exclusion Criteria:
- Hypersensitivity to IMP/components
- Severe adverse reaction/hypersensitivity to other mAbs
- Acute fever/illness/infection within 3 days of planned dosing
- Clinically important illness/procedure/trauma within 4 weeks of IMP administration
- Active infection with Hepatitis B/C
- Clinically significant bleeding disorders
- Known/suspected immune deficiency/suppression
- Receipt of blood products/immunoglobulins or immunosuppressive therapies within 6 months prior to screening (immunosuppressive medications/therapies include glucocorticoids exceeding 2 weeks of prednisone (or equivalent) 20mg daily or every other day)
- Malignancy within previous 5 years; except treated non-melanoma skin cancers and locally treated cervical cancer
- Receipt of any licensed/investigational hMPV vaccine, other therapies and procedures as applicable; participation in other clinical studies
- Screening Abnormalities: clinically significant ECG, positive drug panel, Hgb/platelets/WBC outside of reference; all SCr/AST/ALT > 1.5X ULN
- Women who are pregnant, lactating, or of childbearing potential and not using a highly effective birth control method
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Cohort 1: Low Dose AZD0543
Participants will receive a single AZD0543 dose. |
Sterile solution for injection or infusion administered as a single IM or IV dose on Day 1. |
|
Comparatore placebo: Cohort 1: Placebo
Participants will receive a single dose of placebo. |
Volume-matched 0.9% (w/v) sterile saline solution for injection or infusion administered as a single IM or IV dose on Day 1. |
|
Sperimentale: Cohort 2: Medium Dose AZD0543
Participants will receive a single AZD0543 dose. |
Sterile solution for injection or infusion administered as a single IM or IV dose on Day 1. |
|
Comparatore placebo: Cohort 2: Placebo
Participants will receive a single dose of placebo. |
Volume-matched 0.9% (w/v) sterile saline solution for injection or infusion administered as a single IM or IV dose on Day 1. |
|
Sperimentale: Cohort 3: High Dose AZD0543
Participants will receive a single AZD0543 dose. |
Sterile solution for injection or infusion administered as a single IM or IV dose on Day 1. |
|
Comparatore placebo: Cohort 3: Placebo
Participants will receive a single dose of placebo. |
Volume-matched 0.9% (w/v) sterile saline solution for injection or infusion administered as a single IM or IV dose on Day 1. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Immediate AEs within 1 hour of IMP administration
Lasso di tempo: Within 1 hour of IMP administration
|
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo |
Within 1 hour of IMP administration
|
|
Injection/infusion-related reactions
Lasso di tempo: Within 24 hours of IMP administration
|
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo |
Within 24 hours of IMP administration
|
|
Injection/infusion site reactions
Lasso di tempo: Through Day 8 post-IMP administration
|
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo |
Through Day 8 post-IMP administration
|
|
AEs
Lasso di tempo: Through Day 91 post-IMP administration
|
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo |
Through Day 91 post-IMP administration
|
|
SAEs, MAAEs, and AESIs
Lasso di tempo: Throughout the study post-IMP administration
|
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo |
Throughout the study post-IMP administration
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
AZD0543 serum concentrations over time
Lasso di tempo: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
|
To assess the pharmacokinetics (PK) of AZD0543, in serum |
Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
|
|
AZD0543 Cmax
Lasso di tempo: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
|
To assess the pharmacokinetics (PK) of AZD0543, in serum |
Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
|
|
AZD0543 Tmax
Lasso di tempo: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
|
To assess the pharmacokinetics (PK) of AZD0543, in serum |
Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
|
|
AZD0543 t½λz
Lasso di tempo: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
|
To assess the pharmacokinetics (PK) of AZD0543, in serum |
Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
|
|
AZD0543 AUClast
Lasso di tempo: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
|
To assess the pharmacokinetics (PK) of AZD0543, in serum |
Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
|
|
AZD0543 AUCinf
Lasso di tempo: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
|
To assess the pharmacokinetics (PK) of AZD0543, in serum |
Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
|
|
AZD0543 CL
Lasso di tempo: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
|
To assess the pharmacokinetics (PK) of AZD0543, in serum |
Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
|
|
AZD0543 Vss
Lasso di tempo: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
|
To assess the pharmacokinetics (PK) of AZD0543, in serum |
Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
|
|
AZD0543 Vz
Lasso di tempo: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
|
To assess the pharmacokinetics (PK) of AZD0543, in serum |
Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
|
|
Incidence of ADA; magnitude of ADA response
Lasso di tempo: Study Day 1 baseline; Study Day 8, 31, 91, 151, 361
|
To assess anti-drug antibody (ADA) responses to AZD0543 in serum |
Study Day 1 baseline; Study Day 8, 31, 91, 151, 361
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
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
- D9190C00002
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano 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 are accepting requests for IPD, but this does not mean all requests will be shared.
Periodo di condivisione 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 rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Criteri di accesso alla condivisione IPD
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
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