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AZD7798 Safety, Tolerability, and Pharmacokinetics After a Single Ascending and Repeat Dose Administrations to Healthy Subjects, and Patients With Crohn's Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE1

AZD7798 Safety, Tolerability, and Pharmacokinetics After a Single Ascending and Repeat Dose Administrations to Healthy Subjects, and Patients With Crohn's Disease

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

NCT05452304•AstraZeneca

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Yes

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 who have not had a vasectomy must agree to comply with highly effective methods of contraception from the time of IMP administration until 4 months after the last dose of IMP.
•Non-smoker, or mild smoker (no more than 10 cigarettes per day).
•Have a BMI between 18 and 30 kg/m2 inclusive and weigh at least 45 kg and no more than 100 kg inclusive.
•Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating.
•Provision of signed, written and dated informed consent for optional genetic/biomarker research.
•Evidence of completion of an appropriate vaccination regimen to SARS-CoV-2 at least 14 days prior to screening as appropriate and recommended in contemporaneous local, regional, or national guidelines.
•Part 1 (Healthy Subjects), Part 3a (Healthy Japanese Subjects) and Part 3b (Healthy Chinese Subjects):
+15 more criteria

Exclusion Criteria

•All Study Parts:
•• Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of Investigational Medicinal Product (IMP).
•• Any positive result on Screening for HBsAg, anti-HBc antibody, anti-HCV antibody, and HIV.
•• History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, or, history of hypersensitivity to drugs with a similar chemical structure or class to AZD7798.
•• For females of childbearing potential using hormonal contraception: Use of drugs with enzyme inducing properties such as St John's Wort within 3 weeks prior to the first administration of IMP.
•• Subjects with a positive diagnostic nucleic acid test (using PCR) for SARS-CoV-2 prior to dosing.
•• Live or attenuated vaccine within 4 weeks of Visit 1 and until the end of the follow up period.
•* An active infection, or history of serious infection within the preceding 28 days.
•* Use of antibiotics within 28 days prior to the first administration of IMP.
•* History of symptomatic herpes simplex (excluding cold sores) or herpes zoster infection within 3 months prior to screening.
+30 more criteria

Locations (1)

Research Site

Harrow, United Kingdom

Key Dates

Start Date

July 12, 2022

Primary Completion Date

November 14, 2024

Completion Date

November 27, 2024

Last Updated

December 3, 2025

Enrollment

112

ACTUAL participants

Conditions

Healthy SubjectsCrohns Disease

Interventions

AZD7798

BIOLOGICAL

Placebo

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

AZD7798 Safety, Tolerability, and Pharmacokinetics After a Single Ascending and Repeat Dose Administrations to Healthy Subjects, and Patients With Crohn's Disease

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases

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