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This is a dose exploration study to evaluate the safety and pharmacokinetics (PK) of AZD3152 in healthy adult male and female participants, across different dose levels and routes of administration (ie, Intramuscular [IM] injection and Intravenous [IV] infusion).
The study will be conducted in the United States of America.
Eligible healthy participants will be randomized to receive either AZD3152 or placebo administered IM or IV, across 5 fixed-dose cohorts. Participants will receive a single dose of AZD3152/placebo.
Cohort 1: Dose X of AZD3152 or placebo, as an IM injection Cohort 2: Dose X of AZD3152 or placebo, administered IV Cohort 3: Dose Y of AZD3152 or placebo, as an IM injection Cohort 4: Dose Y of AZD3152 or placebo, administered IV Cohort 5: Dose Z of AZD3152 or placebo, administered IV
The study will comprise of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD3152 Dose X (IM) | Experimental | Participants will receive dose X of AZD3152 on Day 1 as a single IM injection. |
|
| AZD3152 Dose X (IV) | Experimental | Participants will receive dose X of AZD3152 on Day 1 as an IV infusion. |
|
| AZD3152 Dose Y (IM) | Experimental | Participants will receive dose Y of AZD3152 on Day 1 as 2 sequential IM injections. |
|
| AZD3152 Dose Y (IV) | Experimental | Participants will receive dose Y of AZD3152 on Day 1 as an IV infusion. |
|
| AZD3152 Dose Z (IV) | Experimental | Participants will receive dose Z of AZD3152 on Day 1 as an IV infusion. |
|
| Pooled placebo | Placebo Comparator | Participant will receive placebo on Day 1 either via IM injection or IV infusion. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD3152 | Drug | AZD3152 will be administered via IM injection or IV infusion, as per the assigned arms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse event | Evaluation of the safety of IM or IV administration of AZD3152 will be done. | Until Day 91 |
| Number of participants with serious adverse event | Evaluation of the safety of IM or IV administration of AZD3152 will be done. | Until Day 365 or early discontinuation visit (EDV [approximately 19 months]) |
| Number of participants with adverse event of special interest | Evaluation of the safety of IM or IV administration of AZD3152 will be done. | Until Day 365 or EDV (approximately 19 months) |
| Serum concentration of AZD3152 | Pharmacokinetics (PK) characterization of AZD3152 in serum after a single IM or IV dose. | Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months) |
| Maximum observed concentration (Cmax) of AZD3152 | PK (Cmax) characterization of AZD3152 in serum after a single IM or IV dose. | Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months) |
| Time to reach maximum observed concentration (tmax) of AZD3152 | PK (tmax) characterization of AZD3152 in serum after a single IM or IV dose. | Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months) |
| Terminal elimination half-life (t1/2) of AZD3152 | PK (t1/2) characterization of AZD3152 in serum after a single IM or IV dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with anti-drug antibody (ADA) to AZD3152 | Evaluation of ADA responses to AZD3152. | Pre-dose, Days 15, 31, 91, 181, and Day 365 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Anniston | Alabama | 36207 | United States | ||
| Research Site |
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| Label | URL |
|---|---|
| Redated CSR Synopsis | View source |
| Results of this clinical trial are available on www.astrazenecaclinicaltrials.com | View source |
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Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. 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.
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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma 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 deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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|
| Placebo | Other | Placebo is a matching volume of 0.9% sodium chloride, will be administered via IM injection or IV infusion, as per the assigned arms. |
|
| Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months) |
| Area under the serum concentration-curve from 0 to the last quantifiable concentration (AUClast) of AZD3152 | PK (AUClast) characterization of AZD3152 in serum after a single IM or IV dose. | Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months) |
| Area under concentration-time curve from 0 to infinity (AUCinf) of AZD3152 | PK (AUCinf) characterization of AZD3152 in serum after a single IM or IV dose. | Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months) |
| Apparent total body clearance (CL/F) of AZD3152 (IM administration only) | PK (CL/F) characterization of AZD3152 in serum after a single IM. | Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months) |
| Apparent volume of distribution based on terminal phase (Vz/F) of AZD3152 (IM administration only) | PK (Vz/F) characterization of AZD3152 in serum after a single IM. | Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months) |
| Total body clearance (CL) of AZD3152 (IV administration only) | PK (CL) characterization of AZD3152 in serum after a single IV. | Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months) |
| Volume of distribution based on terminal phase (Vz) of AZD3152 (IV administration only) | PK (Vz) characterization of AZD3152 in serum after a single IV. | Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months) |
| Volume of distribution at steady state (Vss) of AZD3152 (IV administration only) | PK (Vss) characterization of AZD3152 in serum after a single IV. | Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months) |
| Cullman |
| Alabama |
| 35055 |
| United States |
| Research Site | Scottsdale | Arizona | 85260 | United States |
| Research Site | Orlando | Florida | 32819 | United States |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |