Human Metapneumovirus Infection
Conditions
Brief summary
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.
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.
Interventions
BIOLOGICALAZD0543
Sterile solution for injection or infusion administered as a single IM or IV dose on Day 1.
OTHERPlacebo
Volume-matched 0.9% (w/v) sterile saline solution for injection or infusion administered as a single IM or IV dose on Day 1.
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immediate AEs within 1 hour of IMP administration | Within 1 hour of IMP administration | To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo |
| Injection/infusion-related reactions | Within 24 hours of IMP administration | To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo |
| Injection/infusion site reactions | Through Day 8 post-IMP administration | To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo |
| AEs | Through Day 91 post-IMP administration | To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo |
| SAEs, MAAEs, and AESIs | Throughout the study post-IMP administration | To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AZD0543 serum concentrations over time | 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 |
| AZD0543 Cmax | 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 |
| AZD0543 Tmax | 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 |
| AZD0543 t½λz | 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 |
| AZD0543 AUClast | 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 |
| AZD0543 AUCinf | 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 |
| AZD0543 CL | 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 |
| AZD0543 Vss | 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 |
| AZD0543 Vz | 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 |
| Incidence of ADA; magnitude of ADA response | Study Day 1 baseline; Study Day 8, 31, 91, 151, 361 | To assess anti-drug antibody (ADA) responses to AZD0543 in serum |
Countries
United States
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed