NCT05452304

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2022

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 11, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

July 12, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2024

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2024

Completed
Last Updated

December 3, 2025

Status Verified

November 1, 2025

Enrollment Period

2.3 years

First QC Date

July 6, 2022

Last Update Submit

November 26, 2025

Conditions

Healthy SubjectsCrohns Disease

Keywords

AZD7798Single ascending doseRepeat doseSentinel dosing

Outcome Measures

Primary Outcomes (1)

  • Number of participants with Adverse Events (AEs)

    The safety and tolerability of AZD7798 following administration of single ascending doses will be assessed.

    Until follow-up (Day 85) or Early termination (ET)

Secondary Outcomes (16)

  • Area under plasma concentration time curve from zero to infinity (AUCinf)

    Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85

  • AUClast

    Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85

  • Maximum serum concentration (Cmax)

    Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85

  • Time to reach maximum serum concentration (tmax)

    Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85

  • Time to last measurable concentration (tlast)

    Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85

  • +11 more secondary outcomes

Study Arms (16)

Part 1a - Cohort 1: AZD7798 dose 1

EXPERIMENTAL

A total of 6 subjects will receive single ascending doses of AZD7798.

Biological: AZD7798

Part 1a - Cohort 2: AZD7798 dose 2

EXPERIMENTAL

A total of 6 subjects will receive single ascending doses of AZD7798.

Biological: AZD7798

Part 1a - Cohort 3: AZD7798 dose 3

EXPERIMENTAL

A total of 6 subjects will receive single ascending doses of AZD7798.

Biological: AZD7798

Part 1a - Cohort 4: AZD7798 dose 4

EXPERIMENTAL

A total of 6 subjects will receive single ascending doses of AZD7798.

Biological: AZD7798

Part 1a - Cohort 5: AZD7798 dose 5

EXPERIMENTAL

A total of 6 subjects will receive single ascending doses of AZD7798.

Biological: AZD7798

Part 1a - Cohort 6: AZD7798 dose 6

EXPERIMENTAL

A total of 6 subjects will receive single ascending doses of AZD7798.

Biological: AZD7798

Part 1a - Cohort 7: AZD7798 dose 7

EXPERIMENTAL

A total of 6 subjects will receive single ascending doses of AZD7798.

Biological: AZD7798

Part 1b - Cohort 8: AZD7798 dose 8

EXPERIMENTAL

A total of 6 subjects will receive repeat doses of AZD7798.

Biological: AZD7798

Part 1a - Spare Cohort 9: AZD7798 dose 9

EXPERIMENTAL

A total of 6 subjects will receive a single ascending dose of AZD7798.

Biological: 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.

Biological: AZD7798

Part 2 - Cohort 11: Placebo + AZD7798

EXPERIMENTAL

A total of 2 subjects will receive placebo on day 1 followed by AZD7798 on day 15.

Biological: AZD7798

Part 2 - Cohort 12: AZD7798 + Placebo

EXPERIMENTAL

A total of 2 subjects will receive AZD7798 on day 1 followed by placebo on day 15.

Biological: AZD7798

Placebo: Part 1a and Part 1b

EXPERIMENTAL

A total of 2 subjects per cohort will receive placebo.

Biological: Placebo

Part 3a - Cohort 12: AZD7798

EXPERIMENTAL

A total of 6 subjects will receive single ascending doses of AZD7798.

Biological: AZD7798

Part 3b - Cohort 13: AZD7798

EXPERIMENTAL

A total of 6 subjects will receive single ascending doses of AZD7798.

Biological: AZD7798

Placebo: Part 3a and Part 3b

EXPERIMENTAL

A total of 2 subjects per cohort will receive placebo.

Biological: Placebo

Interventions

AZD7798BIOLOGICAL

Subjects will receive AZD7798 as a single ascending dose or as a repeat dose.

Part 1a - Cohort 1: AZD7798 dose 1Part 1a - Cohort 2: AZD7798 dose 2Part 1a - Cohort 3: AZD7798 dose 3Part 1a - Cohort 4: AZD7798 dose 4Part 1a - Cohort 5: AZD7798 dose 5Part 1a - Cohort 6: AZD7798 dose 6Part 1a - Cohort 7: AZD7798 dose 7Part 1a - Spare Cohort 9: AZD7798 dose 9Part 1b - Cohort 8: AZD7798 dose 8Part 2 - Cohort 10: AZD7798 + AZD7798Part 2 - Cohort 11: Placebo + AZD7798Part 2 - Cohort 12: AZD7798 + PlaceboPart 3a - Cohort 12: AZD7798Part 3b - Cohort 13: AZD7798
PlaceboBIOLOGICAL

Subjects will receive placebo matching the AZD7798 dose as a single ascending dose or as a repeat dose.

Placebo: Part 1a and Part 1bPlacebo: Part 3a and Part 3b

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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):
  • Healthy male and female (of childbearing and non childbearing potential) subjects aged 18 to 50 years inclusive.
  • Part 1a (in case of dose escalation in patients) and Part 2 (Patients with Crohn's Disease):
  • Male and female (of childbearing and non childbearing potential) patients with Crohn's disease aged 18 to 60 years inclusive.
  • Patients with confirmed Crohn's disease (diagnosed via endoscopy, histology and/or imaging) with onset of symptoms at least 3 months prior to screening.
  • Active disease, defined by at least one symptom and sign consistent with Crohn's disease AND at least one of the following:
  • +10 more criteria

You may not qualify if:

  • 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.
  • Positive or indeterminate TB QuantiFERON test.
  • Has received another new chemical entity within 30 days/5 half-lives of the first administration of IMP in this study.
  • Subjects who cannot communicate reliably with the Investigator.
  • Vulnerable subjects.
  • Part 1 (Healthy Subjects), Part 3a (Japanese Subjects, and Part 3b (Chinese Subjects):
  • +23 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Harrow, HA1 3UJ, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2022

First Posted

July 11, 2022

Study Start

July 12, 2022

Primary Completion

November 14, 2024

Study Completion

November 27, 2024

Last Updated

December 3, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
More information

Locations

GB(1)