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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05452304 | AZD7798 Safety, Tolerability, and Pharmacokinetics After a Single Ascending and Repeat Dose Administrations to Healthy Subjects, and Patients With Crohn's Disease | PHASE1 | COMPLETED | 112 | — | — | Jul 12, 2022 | Nov 27, 2024 | Dec 3, 2025 | 1 | United Kingdom |
The safety and tolerability of AZD7798 following administration of single ascending doses will be assessed.
| Arm | Type | Description |
|---|---|---|
| Part 1a - Cohort 1: AZD7798 dose 1 | EXPERIMENTAL | A total of 6 subjects will receive single ascending doses of AZD7798. |
| Part 1a - Cohort 2: AZD7798 dose 2 | EXPERIMENTAL | A total of 6 subjects will receive single ascending doses of AZD7798. |
| Part 1a - Cohort 3: AZD7798 dose 3 | EXPERIMENTAL | A total of 6 subjects will receive single ascending doses of AZD7798. |
| Part 1a - Cohort 4: AZD7798 dose 4 | EXPERIMENTAL | A total of 6 subjects will receive single ascending doses of AZD7798. |
| Part 1a - Cohort 5: AZD7798 dose 5 | EXPERIMENTAL | A total of 6 subjects will receive single ascending doses of AZD7798. |
| Part 1a - Cohort 6: AZD7798 dose 6 | EXPERIMENTAL | A total of 6 subjects will receive single ascending doses of AZD7798. |
| Part 1a - Cohort 7: AZD7798 dose 7 | EXPERIMENTAL | A total of 6 subjects will receive single ascending doses of AZD7798. |
| Part 1b - Cohort 8: AZD7798 dose 8 | EXPERIMENTAL | A total of 6 subjects will receive repeat doses of AZD7798. |
| Part 1a - Spare Cohort 9: AZD7798 dose 9 | EXPERIMENTAL | A total of 6 subjects will receive a single ascending dose of AZD7798. |
| Part 2 - Cohort 10: AZD7798 + AZD7798 | EXPERIMENTAL | A total of 4 subjects will receive a single dose on Day 1 followed by a single dose on Day 15. |
| Part 2 - Cohort 11: Placebo + AZD7798 | EXPERIMENTAL | A total of 2 subjects will receive placebo on day 1 followed by AZD7798 on day 15. |
| Part 2 - Cohort 12: AZD7798 + Placebo | EXPERIMENTAL | A total of 2 subjects will receive AZD7798 on day 1 followed by placebo on day 15. |
| Placebo: Part 1a and Part 1b | EXPERIMENTAL | A total of 2 subjects per cohort will receive placebo. |
| Part 3a - Cohort 12: AZD7798 | EXPERIMENTAL | A total of 6 subjects will receive single ascending doses of AZD7798. |
| Part 3b - Cohort 13: AZD7798 | EXPERIMENTAL | A total of 6 subjects will receive single ascending doses of AZD7798. |
| Placebo: Part 3a and Part 3b | EXPERIMENTAL | A total of 2 subjects per cohort will receive placebo. |
| Name | Type | Description |
|---|---|---|
| AZD7798 | BIOLOGICAL | Subjects will receive AZD7798 as a single ascending dose or as a repeat dose. |
| Placebo | BIOLOGICAL | Subjects will receive placebo matching the AZD7798 dose as a single ascending dose or as a repeat dose. |
Inclusion Criteria: All Study Parts: * Provision of signed and dated, written informed consent prior to any study specific procedures. * Subjects must have suitable veins for cannulation or repeated venepuncture. * Males who are sexually active with a female partner of childbearing potential and w...