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AZD1613 · 1 trial · 1 indication
To assess the safety and tolerability of AZD1613 following SC and/or IV administration of single and multiple ascending doses.
| Arm | Type | Description |
|---|---|---|
| Part A1 (SAD): AZD1613 (Dose 1) SC | EXPERIMENTAL | Participants will receive a single dose of AZD1613 (Dose 1) or matching placebo to AZD1613 as SC injection on Day 1. |
| Part A1 (SAD): AZD1613 (Dose 2) SC | EXPERIMENTAL | Participants will receive a single dose of AZD1613 (Dose 2) or matching placebo to AZD1613 as SC injection on Day 1. |
| Part A1 (SAD): AZD1613 (Dose 3) SC | EXPERIMENTAL | Participants will receive a single dose of AZD1613 (Dose 3) or matching placebo to AZD1613 as SC injection on Day 1. |
| Part A1 (SAD): AZD1613 (Dose 4) SC | EXPERIMENTAL | Participants will receive a single dose of AZD1613 (Dose 4) or matching placebo to AZD1613 as SC injection on Day 1. |
| Part A1 (SAD): AZD1613 (Dose 5) IV | EXPERIMENTAL | Participants will receive a single dose of AZD1613 (Dose 5) or matching placebo to AZD1613 as an IV infusion on Day 1. |
| Part A1 (SAD): AZD1613 (Dose 6) IV | EXPERIMENTAL | Participants will receive a single dose of AZD1613 (Dose 6) or matching placebo to AZD1613 as an IV infusion on Day 1. |
| Part A1 (SAD): AZD1613 (Dose 7) IV | EXPERIMENTAL | Participants will receive a single dose of AZD1613 (Dose 7) or matching placebo to AZD1613 as an IV infusion on Day 1. |
| Part A2 (SAD): AZD1613 (Dose 8) IV (Chinese) | EXPERIMENTAL | Chinese participants will receive a single dose of AZD1613 (Dose 8) or matching placebo to AZD1613 as an IV infusion on Day 1. |
| Part A3 (SAD): AZD1613 (Dose 9) SC or IV (Japanese) | EXPERIMENTAL | Japanese participants will receive a single dose of AZD1613 (Dose 9) or matching placebo to AZD1613 as SC injection or IV infusion on Day 1. |
| Part A3 (SAD): AZD1613 (Dose 10) SC or IV (Japanese) | EXPERIMENTAL | Japanese participants will receive a single dose of AZD1613 (Dose 10) or matching placebo to AZD1613 as SC injection or IV infusion on Day 1. |
| Part B (MAD): AZD1613 (Dose 11) SC or IV | EXPERIMENTAL | Participants will receive multiple doses of AZD1613 (Dose 11) or matching placebo to AZD1613 as SC injection or IV infusion on Days 1, 29 and 57. |
| Part B (MAD): AZD1613 (Dose 12) IV | EXPERIMENTAL | Participants will receive multiple doses of AZD1613 (Dose 12) or matching placebo to AZD1613 as an IV infusion on Days 1, 29 and 57. |
| Part B (MAD): AZD1613 (Dose 13) IV | EXPERIMENTAL | Participants will receive multiple doses of AZD1613 (Dose 13) or matching placebo to AZD1613 as an IV infusion on Days 1, 29 and 57. |
| Name | Type | Description |
|---|---|---|
| AZD1613 | DRUG | AZD1613 will be administered as either SC injection or IV infusion on Day 1 in Part A and on Days 1, 29 and 57 in Part B of the study. |
| Placebo | DRUG | Placebo will be administered as either SC injection or IV infusion on Day 1 in Part A and Days 1, 29 and 57 in Part B of the study. |
Inclusion Criteria: 1. Healthy males and females of non-childbearing potential with suitable veins for cannulation or repeated venipuncture. 2. Negative pregnancy test at screening and admission (females only). 3. Females of non-childbearing potential confirmed by postmenopausal status or irreversi...
AZD1613 is an investigational small molecule being studied in healthy participants. It is currently in Phase 1 clinical development to evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity. The drug is not approved for any indication and is still in early-stage clinical trials.
AZD1613 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting a Phase 1 clinical trial to investigate the drug's properties in healthy volunteers.
AZD1613 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is currently recruiting participants to study the drug's safety and other characteristics in healthy individuals.
AZD1613 is being studied in one active clinical trial with the identifier NCT06995820. This Phase 1 study is investigating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of AZD1613 in healthy participants. The trial is recruiting in the United States and aims to enroll 136 participants aged 18 years and older.
AZD1613 is the only name provided for this investigational drug. It is a small molecule being developed by AstraZeneca. No alternative names or aliases have been associated with this compound in the available information.