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Also known as AZD2373-Arm 1, AZD2373-Arm 2
AZD2373 · 2 trials · 1 indication
To assess the safety and tolerability of subcutaneous (SC) multiple ascending dose (MAD) administrations of AZD2373.
To assess adverse events as a variable of safety and tolerability of subcutaneous (SC) single ascending dose (SAD) administrations of AZD2373
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Once weekly dosing for 4 weeks (Dosing Days 1, 8, 15 and 22) OR Once weekly dosing for 6 weeks (Dosing Days 1, 8, 15, 22, 29 and 36) randomized subjects will receive a subcutaneous (SC) injection of AZD2373 dose 1 (6 subjects) or matching placebo (2 subjects). |
| Cohort 2 | EXPERIMENTAL | Once weekly for 6 weeks dosing on Days 1, 8, 15, 22, 29 and 36 randomized subjects will receive a subcutaneous (SC) injection of AZD2373 dose 2 (6 subjects) or matching placebo (2 subjects). |
| Cohort 3 | EXPERIMENTAL | Three times weekly for 6 weeks dosing each week on Days 1, 3, and 5 randomized subjects will receive a subcutaneous (SC) injection of AZD2373 dose 3 (6 subjects) or matching placebo (2 subjects). |
| Cohort 4 (optional) | EXPERIMENTAL | Between one to seven doses each week for 6 weeks randomized subjects will receive a subcutaneous (SC) injection of AZD2373 dose 4 (6 subjects) or matching placebo (2 subjects). |
| Cohort 5 (optional) | EXPERIMENTAL | Between one to seven doses each week for 6 weeks randomized subjects will receive a subcutaneous (SC) injection of AZD2373 dose 5 (6 subjects) or matching placebo (2 subjects). |
| Cohort 4 | EXPERIMENTAL | On Day 1, randomized subjects will receive a SC injection of AZD2373 dose 4 (6 subjects) or matching placebo (2 subjects). |
| Cohort 5 | EXPERIMENTAL | On Day 1, randomized subjects will receive a SC injection of AZD2373 dose 5 (6 subjects) or matching placebo (2 subjects). |
| Cohort 6 | EXPERIMENTAL | On Day 1, randomized subjects will receive a SC injection of AZD2373 dose 6 (6 subjects) or matching placebo (2 subjects). |
| Name | Type | Description |
|---|---|---|
| AZD2373 subcutaneous injection | DRUG | Randomized subjects will receive multiple ascending dose of AZD2373 by SC injection (dose 1, dose 2, dose 3, dose 4, dose 5). |
| Placebo | DRUG | Randomized subjects will receive a multiple ascending dose of placebo (saline solution) by SC injection. |
Inclusion Criteria: 1. Provision of signed and dated, written informed consent prior to any study specific procedures. 2. Healthy male participants of sub-Saharan West African ancestry aged 18 to 55 years (inclusive, at time of informed consent) 3. Have a BMI between 18.5 and 35 kg/m2 (inclusive) a...
AZD2373 is an investigational small molecule being studied in healthy volunteers. It is not approved for any disease and is in Phase 1 clinical development. The studies focus on safety, tolerability, pharmacokinetics, and pharmacodynamics after single dose administration in healthy male subjects.
AZD2373 is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting Phase 1 clinical trials to evaluate the drug's safety and pharmacological profile in healthy volunteers.
AZD2373 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 studies have been completed, both involving healthy male volunteers.
AZD2373 has two completed Phase 1 trials: NCT04269031, which enrolled 30 healthy male subjects of African ancestry, and NCT05351047, which enrolled 24 healthy male participants of Sub-Saharan West African ancestry. Both were conducted in the United States.
Yes, AZD2373 is also known as AZD2373-Arm 1 and AZD2373-Arm 2. These alternative names refer to the same drug, which is being investigated in Phase 1 clinical trials by AstraZeneca.