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This study will assess the safety, tolerability and pharmacokinetics (PK) of AZD0292 following intravenous (IV) administration of single ascending doses to healthy adult participants.
This is a First-time-in-human (FTiH) trial.
Eligible participants will be randomized to receive AZD0292 or Placebo. Participants will receive pre-medication with an antihistamine prior to dosing with the study intervention.
The study will comprise:
Participants will be involved in this study for a maximum duration of 13 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD0292 Dose 1 | Experimental | Participants will receive single dose of AZD0292 dose 1 as IV infusion on Day 1. |
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| AZD0292 Dose 2 | Experimental | Participants will receive single dose of AZD0292 dose 2 as IV infusion on Day 1. |
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| AZD0292 Dose 3 | Experimental | Participants will receive single dose of AZD0292 dose 3 as IV infusion on Day 1. |
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| Placebo | Placebo Comparator | Participants will receive matching placebo to AZD0292 as IV infusion on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD0292 | Drug | AZD0292 will be administered as single dose via IV infusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events | The safety and tolerability of AZD0292 following IV administration of single ascending doses to healthy adult participants will be assessed. | Up to 13 weeks |
| Number of Participants with Adverse Events of Special Interest (AESI) | The safety and tolerability of AZD0292 following IV administration of single ascending doses to healthy adult participants will be assessed. | Up to 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Drug Concentration (Cmax) | The PK (Cmax) of AZD0292 following IV administration of single ascending doses of AZD0292 to healthy adult participants will be assessed. | From Dosing (Day 1) to end of the study (up to 13 weeks) |
| Area Under Concentration-Curve from Time Zero to the Last Quantifiable Concentration (AUClast) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Baltimore | Maryland | 21225 | United States |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via there quest 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 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 athttps://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 | Drug | Placebo will be administered as IV infusion. |
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The PK (AUClast) of AZD0292 following IV administration of single ascending doses of AZD0292 to healthy adult participants will be assessed. |
| From Dosing (Day 1) to end of the study (up to 13 weeks) |
| Area Under Concentration-Time Curve from Time Zero to Infinity (AUCinfinity) | The PK (AUCinfinity) of AZD0292 following IV administration of single ascending doses of AZD0292 to healthy adult participants will be assessed. | From Dosing (Day 1) to end of the study (up to 13 weeks) |
| Number of Participants with Positive Anti-drug Antibodies (ADAs) | The ADA responses following IV administration of single ascending doses of AZD0292 to healthy adult participants will be evaluated. | From Dosing (Day 1) to end of the study (up to 13 weeks) |