Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-26 @ 9:45 PM
Study NCT ID:
NCT05452304
Status:
COMPLETED
Last Update Posted:
2025-12-03
First Post:
2022-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AZD7798 Safety, Tolerability, and Pharmacokinetics After a Single Ascending and Repeat Dose Administrations to Healthy Subjects, and Patients With Crohn's Disease
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
A Phase 1 Randomised, Double-Blind, Placebo-Controlled 3 Part Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7798 Following Single Ascending Dose Administration and Repeat Dose Administration in Healthy Subjects (Including Japanese and Chinese Subjects), and Patients With Crohn's Disease
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will assess the safety, tolerability, immunogenicity, and pharmacokinetics (PK), and explore the pharmacodynamics (PD) following single ascending dose administration and repeat dose administration in healthy subjects and patients with Crohn's disease.
Detailed Description:
This is a Phase I, randomised, double-blind, placebo controlled study in healthy male and female subjects as well as patients with Crohn's disease performed at a single study centre.
This study is comprised of 3 parts: Part 1 (sub-parts 1a and 1b), Part 2, and Part 3 (sub-Parts 3a and 3b).
* Part 1a: This is a First-In-Human (FIH), single ascending dose (SAD) sequential group study. Up to 7 dose levels of AZD7798 are planned to be investigated. Depending on the findings, an additional dose may be added. Up to 80 healthy subjects are planned to be included. Eight subjects will participate in each single dose cohort. Within each cohort, 6 subjects will be randomised to receive AZD7798, and 2 subjects will be randomised to receive placebo. Each subject will be enrolled up to 113 days (approximately 16 weeks).
* Part 1b: Up to 8 subjects will be randomised to receive a planned dose of AZD7798 (up to 6 subjects) or placebo (up to 2 subjects) on Day 1 and Day 15. This cohort is planned to start after completion of the single dose level cohort in Part 1a. Each subject will be enrolled up to 149 days (approximately 21 weeks).
* Part 2: Up to 8 patients will be randomised (2:1:1) into 1 of 3 strata and receive:
* Stratum 1: AZD7798 on Day 1 and Day 15 (up to 4 patients).
* Stratum 2: Placebo on Day 1 and AZD7798 on Day 15 (up to 2 patients).
* Stratum 3: AZD7798 on Day 1 and placebo on Day 15 (up to 2 patients). Each subject will be enrolled up to 149 days (approximately 21 weeks).
* Part 3: Subjects will be randomised to AZD7798 or placebo in a ratio of 3:1 (up to 6 subjects will receive AZD7798 and up to 2 subjects will receive placebo).
This study is comprised of 3 parts: Part 1 (sub-parts 1a and 1b), Part 2, and Part 3 (sub-Parts 3a and 3b).
* Part 1a: This is a First-In-Human (FIH), single ascending dose (SAD) sequential group study. Up to 7 dose levels of AZD7798 are planned to be investigated. Depending on the findings, an additional dose may be added. Up to 80 healthy subjects are planned to be included. Eight subjects will participate in each single dose cohort. Within each cohort, 6 subjects will be randomised to receive AZD7798, and 2 subjects will be randomised to receive placebo. Each subject will be enrolled up to 113 days (approximately 16 weeks).
* Part 1b: Up to 8 subjects will be randomised to receive a planned dose of AZD7798 (up to 6 subjects) or placebo (up to 2 subjects) on Day 1 and Day 15. This cohort is planned to start after completion of the single dose level cohort in Part 1a. Each subject will be enrolled up to 149 days (approximately 21 weeks).
* Part 2: Up to 8 patients will be randomised (2:1:1) into 1 of 3 strata and receive:
* Stratum 1: AZD7798 on Day 1 and Day 15 (up to 4 patients).
* Stratum 2: Placebo on Day 1 and AZD7798 on Day 15 (up to 2 patients).
* Stratum 3: AZD7798 on Day 1 and placebo on Day 15 (up to 2 patients). Each subject will be enrolled up to 149 days (approximately 21 weeks).
* Part 3: Subjects will be randomised to AZD7798 or placebo in a ratio of 3:1 (up to 6 subjects will receive AZD7798 and up to 2 subjects will receive placebo).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2022-001438-12 | EUDRACT_NUMBER | None | View |