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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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The purpose of this study is to evaluate the safety and PK of AZD7760 when given as an intravenous (IV) infusion to healthy Japanese adult participants.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (AZD7760 Dose A) | Experimental | Participants receive an IV infusion of AZD7760 Dose A on Day 1. |
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| Cohort 2 (AZD7760 Dose B) | Experimental | Participants receive an IV infusion of AZD7760 Dose B on Day 1. |
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| Pooled Placebo | Placebo Comparator | Participants receive an IV infusion of matching placebo on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD7760 | Drug | Participants will receive AZD7760 via IV infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Adverse Events (AEs) | 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) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed serum (peak) drug concentration (Cmax) | 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) |
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Inclusion Criteria:
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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Sumida-ku | 130-0004 | Japan |
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 is accepting requests for IPD, but this does not mean all requests will be approved.
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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 refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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| Placebo | Other | Participants will receive matching placebo via IV infusion. |
|
To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.
| Day 1 to Day 361 |
| Terminal elimination half-life (t½λz) | 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) | 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) | 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) | 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) | To characterize the PK of AZD7760 in serum of healthy Japanese adult participants. | Day 1 to Day 361 |
| Incidence of Anti-drug antibody (ADA) | To evaluate ADA responses to AZD7760 in serum of healthy Japanese adult participants | Day 1 to Day 361 |