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The study will evaluate the safety, tolerability, and the pharmacokinetics (PK) of AZD7503 following multiple subcutaneous doses in healthy Japanese participants.
This is a Phase I, randomised, single-blind, placebo-controlled study. The healthy Japanese participants will receive randomly (3:1) either AZD7503 or placebo subcutaneously.
The study will comprise of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD7503 | Experimental | Participants will subcutaneously receive AZD7503. |
|
| Placebo | Placebo Comparator | Participants will subcutaneously receive placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD7053 | Drug | Randomised participants will receive AZD7503 subcutaneously. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | The safety and tolerability after multiple doses of AZD7503 in healthy Japanese participants will be evaluated. | From Screening (Day -28) until Follow-up Day 127 (10 weeks post last dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma drug concentration (Cmax) | The Cmax after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated. | Day 1, Day 2, Day 3, Day 5, Day 15, Day 29, Day 57, Day 58, and Day 59 |
| Are under plasma concentration-time curve from time 0 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 | Sumida-ku | 130-0004 | Japan |
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| Label | URL |
|---|---|
| Redacted\_CSR Synopsis\_D9230C00005 | View source |
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The study is single blind where the study site staff including the investigator will remain blinded during the clinical conduct of a given cohort.
| Placebo |
| Drug |
Randomised participants will receive placebo subcutaneously. |
|
The AUClast after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated. |
| Day 1, Day 2, Day 3, Day 5, Day 15, Day 29, Day 57, Day 58, and Day 59 |
| Area under plasma concentration-time curve from time 0 to infinity (AUCinf) | The AUCinf after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated. | Day 1, Day 2, Day 3, Day 5, Day 15, Day 29, Day 57, Day 58, and Day 59 |
| Area under plasma concentration-time curve during a dosing interval (AUCtau) | The AUCtau after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated. | Day 1, Day 2, Day 3, Day 5, Day 15, Day 29, Day 57, Day 58, and Day 59 |
| Amount of analyte excreted into the urine (Ae) | The Ae after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated. | Day 1, Day 2, Day 3, Day 58, and Day 59 |
| Fraction of the dose excreted unchanged in urine (Fe) | The Fe after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated. | Day 1, Day 2, Day 3, Day 58, and Day 59 |
| Plasma concentration of AZD7503 | The plasma concentration after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated. | Day 1, Day 2, Day 3, Day 58, and Day 59 |
| Plasma concentration of unconjugated antisense oligonucleotide (ASO) | The plasma concentration of unconjugated ASO at specified timepoints after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated. | Day 1, Day 2, Day 3, Day 58, and Day 59 |