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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 1
Kontakte und Standorte
Studienkontakt
- Name: AstraZeneca Clinical Study Information Center
- Telefonnummer: 1-877-240-9479
- E-Mail: information.center@astrazeneca.com
Studienorte
-
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California
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Los Alamitos, California, Vereinigte Staaten, 90720
- Rekrutierung
- Research Site
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Florida
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South Miami, Florida, Vereinigte Staaten, 33143
- Rekrutierung
- Research Site
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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. |
|
Placebo-Komparator: 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. |
|
Experimental: 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. |
|
Placebo-Komparator: 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. |
|
Experimental: 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. |
|
Placebo-Komparator: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Immediate AEs within 1 hour of IMP administration
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
AZD0543 serum concentrations over time
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- D9190C00002
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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.
IPD-Sharing-Zeitrahmen
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.
IPD-Sharing-Zugriffskriterien
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.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
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