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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1: Low Dose AZD0543 		Participants will receive a single AZD0543 dose.
  • Biological: AZD0543
    Sterile solution for injection or infusion administered as a single IM or IV dose on Day 1.
Placebo Comparator
Cohort 1: Placebo 		Participants will receive a single dose of placebo.
  • Other: 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.
  • Biological: AZD0543
    Sterile solution for injection or infusion administered as a single IM or IV dose on Day 1.
Placebo Comparator
Cohort 2: Placebo 		Participants will receive a single dose of placebo.
  • Other: 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.
  • Biological: AZD0543
    Sterile solution for injection or infusion administered as a single IM or IV dose on Day 1.
Placebo Comparator
Cohort 3: Placebo 		Participants will receive a single dose of placebo.
  • Other: 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.

Recruiting Locations

Research Site
South Miami, Florida 33143

More Details

Status
Recruiting
Sponsor
AstraZeneca

Study Contact

AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.