Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05351047 | A Study to Assess Safety, Tolerability, PK and PD of AZD2373 in Healthy Male Participants of Sub-Saharan West African Ancestry | PHASE1 | COMPLETED | 24 | — | — | Apr 4, 2022 | Jul 6, 2023 | Aug 7, 2023 | 1 | United States |
| NCT04269031 | A First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD2373 After Single Dose Administration in Healthy Male Subjects of African Ancestry. | PHASE1 | COMPLETED | 30 | — | — | Feb 13, 2020 | Aug 31, 2021 | Jul 10, 2023 | 1 | United States |
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...