Healthy SubjectsPhase 1NCT05452304
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 study testing AZD7798 in people with Healthy Subjects and Crohns Disease, run by AstraZeneca at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, Crohns Disease
- What is being tested?
- AZD7798
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Jul 2022to 27 Nov 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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:
- CRP > 5mg/L at screening.
- Faecal calprotectin > 250μg/g at screening.
- Evidence of active inflammation on cross-sectional imaging within past 3 months prior to screening.
- Evidence of active inflammation on endoscopy within past 3 months prior to screening.
- Part 3a (Japanese Subjects) • Subject is a native of Japan; defined as having both parents and 4 grandparents who are Japanese. This includes second and third generation subjects of Japanese descent whose parents or grandparents are living in a country other than Japan.
- Part 3b (Chinese Subjects)
- Healthy Chinese subjects. Subjects of Chinese ancestry are eligible based on meeting all of the following:
- Born in mainland China, Hong Kong, or Taiwan.
- Descendants of 4 ethnic Chinese grandparents and 2 ethnic Chinese parents.
- Have lived outside China for less than 10 years at the time of screening.
Who cannot join
- 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.
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- 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):
- Any laboratory values with deviations.
- Any clinically important abnormalities in clinical chemistry, haematology or urinalysis results other than those described under exclusion criterion number 20, as judged by the Investigator.
- Abnormal vital signs, after 5 minutes supine rest at screening and admission.
- Known or suspected history of drug abuse in the last 1 year as judged by the Investigator.
- History of alcohol abuse or excessive intake of alcohol within the last 1 year. as judged by the Investigator.
- Positive screen for drugs of abuse at screening or admission to the Clinical Unit or positive screen for alcohol on admission to the Clinical Unit prior to the first administration of the IMP.
- Excessive intake of caffeine containing drinks or food (eg, coffee, tea, chocolate,) as judged by the Investigator.
- Part 1a (in case of dose escalation in patients) and Part 2 (Patients with Crohn's Disease):
- Patients with any uncontrolled medical conditions, other than active Crohn's disease, that in the opinion of the Investigator put the patient at unacceptable risk or interfere with study assessments or integrity of the data.
- Current diagnosis of ulcerative colitis, indeterminate colitis, inflammatory bowel disease-unclassified, infectious colitis, or ischaemic colitis.
- History of CMV colitis 12 months prior to screening.
- Patients with fulminant Crohn's disease or toxic megacolon.
- Planned surgery for Crohn's disease prior to the end of study follow up visit.
- Patients with symptomatic intestinal stenosis, known pre-stenotic dilatation, undrained fistula(e), or abscesses.
- Initiation or change in dose of azathioprine or mercaptopurine (including initiation or discontinuation of allopurinol) within 4 weeks of the first administration of IMP.
- Treatment with methotrexate, ciclosporin, tacrolimus or thalidomide within 4 weeks of the first administration of IMP.
- Treatment with an anti-TNF biologic within 8 weeks of the first administration of IMP, unless therapeutic drug monitoring is performed and drug concentrations are undetectable.
- Treatment with any biologic, other than an anti-TNF, within 12 weeks or with undetectable serum concentrations prior to the first administration of IMP, unless therapeutic drug monitoring is performed and drug concentrations are undetectable.
- Treatment with rituximab within 12 months prior to the first administration of IMP.
- Any laboratory values with deviations.
- Any clinically important abnormalities in clinical chemistry, haematology or urinalysis results other than those described under exclusion criterion number 49, as judged by the Investigator.
- Abnormal vital signs, after 5 minutes supine rest, defined as any of the following at screening and admission.
- Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG and any clinically important abnormalities in the 12 lead ECG.
- Unstable lifestyle factors, such as alcohol use to excess or recreational drug use, to the extent that in the opinion of the Investigator they would interfere with the ability of a patient to complete the study.
- Current malignancy or history of malignancy.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Healthy Subjects, Crohns Disease
- Being tested
- AZD7798, Placebo
- Keywords
- AZD7798, Single ascending dose, Repeat dose, Sentinel dosing
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD7798Biological
Subjects will receive AZD7798 as a single ascending dose or as a repeat dose.
PlaceboBiological
Subjects will receive placebo matching the AZD7798 dose as a single ascending dose or as a repeat dose.
| Study group | Role | What they receive |
|---|---|---|
| Part 1a - Cohort 1: AZD7798 dose 1 | Experimental | A total of 6 subjects will receive single ascending doses of AZD7798. Receives: Biological: AZD7798 |
| Part 1a - Cohort 2: AZD7798 dose 2 | Experimental | A total of 6 subjects will receive single ascending doses of AZD7798. Receives: Biological: AZD7798 |
| Part 1a - Cohort 3: AZD7798 dose 3 | Experimental | A total of 6 subjects will receive single ascending doses of AZD7798. Receives: Biological: AZD7798 |
| Part 1a - Cohort 4: AZD7798 dose 4 | Experimental | A total of 6 subjects will receive single ascending doses of AZD7798. Receives: Biological: AZD7798 |
| Part 1a - Cohort 5: AZD7798 dose 5 | Experimental | A total of 6 subjects will receive single ascending doses of AZD7798. Receives: Biological: AZD7798 |
| Part 1a - Cohort 6: AZD7798 dose 6 | Experimental | A total of 6 subjects will receive single ascending doses of AZD7798. Receives: Biological: AZD7798 |
| Part 1a - Cohort 7: AZD7798 dose 7 | Experimental | A total of 6 subjects will receive single ascending doses of AZD7798. Receives: Biological: AZD7798 |
| Part 1b - Cohort 8: AZD7798 dose 8 | Experimental | A total of 6 subjects will receive repeat doses of AZD7798. Receives: Biological: AZD7798 |
| Part 1a - Spare Cohort 9: AZD7798 dose 9 | Experimental | A total of 6 subjects will receive a single ascending dose of AZD7798. Receives: 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. Receives: 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. Receives: 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. Receives: Biological: AZD7798 |
| Placebo: Part 1a and Part 1b | Experimental | A total of 2 subjects per cohort will receive placebo. Receives: Biological: Placebo |
| Part 3a - Cohort 12: AZD7798 | Experimental | A total of 6 subjects will receive single ascending doses of AZD7798. Receives: Biological: AZD7798 |
| Part 3b - Cohort 13: AZD7798 | Experimental | A total of 6 subjects will receive single ascending doses of AZD7798. Receives: Biological: AZD7798 |
| Placebo: Part 3a and Part 3b | Experimental | A total of 2 subjects per cohort will receive placebo. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events (AEs)
The safety and tolerability of AZD7798 following administration of single ascending doses will be assessed.
Measured: Until follow-up (Day 85) or Early termination (ET)
Secondary outcomes (16)
Area under plasma concentration time curve from zero to infinity (AUCinf)
The AUCinf of AZD7798 following administration of single ascending doses will be assessed.
Measured: Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
AUClast
The AUClast of AZD7798 following administration of single ascending doses will be assessed.
Measured: Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Maximum serum concentration (Cmax)
The Cmax of AZD7798 following administration of single ascending doses will be assessed.
Measured: Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Time to reach maximum serum concentration (tmax)
The tmax of AZD7798 following administration of single ascending doses will be assessed.
Measured: Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Time to last measurable concentration (tlast)
The tlast of AZD7798 following administration of single ascending doses will be assessed.
Measured: Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Terminal elimination half-life (t½λz)
The t½λz of AZD7798 following administration of single ascending doses will be assessed.
Measured: Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Systemic clearance (CL)
The CL of AZD7798 following administration of single ascending doses will be assessed.
Measured: Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Apparent total clearance (CL/F)
The CL/F of AZD7798 following administration of single ascending doses will be assessed.
Measured: Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Volume of distribution based on the terminal phase (Vz)
The Vz of AZD7798 following administration of single ascending doses will be assessed.
Measured: Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Apparent volume of distribution based on terminal phase (Vz/F)
The Vz/F of AZD7798 following administration of single ascending doses will be assessed.
Measured: Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Bioavailability (F)
The F of AZD7798 following administration of single ascending doses will be assessed.
Measured: Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Volume of distribution at steady state (Vss)
The Vss of AZD7798 following administration of single ascending doses will be assessed.
Measured: Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
AUClast/D
The AUClast/D of AZD7798 following administration of single ascending doses will be assessed.
Measured: Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
AUCinf/D
The AUCinf/D of AZD7798 following administration of single ascending doses will be assessed.
Measured: Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Cmax/D
The Cmax/D of AZD7798 following administration of single ascending doses will be assessed.
Measured: Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Percentage of patients with antidrug antibodies (ADAs)
The immunogenicity of AZD7798 following administration of single ascending doses will be assessed.
Measured: Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start12 Jul 2022
- Primary completion14 Nov 2024
- Study completion27 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452304
- Sponsor's protocol ID
- D9690C00001
- Other IDs
- 2022-001438-12
- Status last verified
- Nov 2025
- First submitted
- 6 Jul 2022
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05452304
- Acronym / sponsor ID
- D9690C00001
- Conditions
- Healthy Subjects, Crohns Disease
- Keywords
- AZD7798, Single ascending dose, Repeat dose, Sentinel dosing
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 14 Nov 2024 (actual)
- Study completion
- 27 Nov 2024 (actual)
- First posted
- 11 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Part 1a - Cohort 1: AZD7798 dose 1 | Experimental | Biological: AZD7798A total of 6 subjects will receive single ascending doses of AZD7798. |
| Part 1a - Cohort 2: AZD7798 dose 2 | Experimental | Biological: AZD7798A total of 6 subjects will receive single ascending doses of AZD7798. |
| Part 1a - Cohort 3: AZD7798 dose 3 | Experimental | Biological: AZD7798A total of 6 subjects will receive single ascending doses of AZD7798. |
| Part 1a - Cohort 4: AZD7798 dose 4 | Experimental | Biological: AZD7798A total of 6 subjects will receive single ascending doses of AZD7798. |
| Part 1a - Cohort 5: AZD7798 dose 5 | Experimental | Biological: AZD7798A total of 6 subjects will receive single ascending doses of AZD7798. |
| Part 1a - Cohort 6: AZD7798 dose 6 | Experimental | Biological: AZD7798A total of 6 subjects will receive single ascending doses of AZD7798. |
| Part 1a - Cohort 7: AZD7798 dose 7 | Experimental | Biological: AZD7798A total of 6 subjects will receive single ascending doses of AZD7798. |
| Part 1b - Cohort 8: AZD7798 dose 8 | Experimental | Biological: AZD7798A total of 6 subjects will receive repeat doses of AZD7798. |
| Part 1a - Spare Cohort 9: AZD7798 dose 9 | Experimental | Biological: AZD7798A total of 6 subjects will receive a single ascending dose of AZD7798. |
| Part 2 - Cohort 10: AZD7798 + AZD7798 | Experimental | Biological: AZD7798A 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 | Biological: AZD7798A total of 2 subjects will receive placebo on day 1 followed by AZD7798 on day 15. |
| Part 2 - Cohort 12: AZD7798 + Placebo | Experimental | Biological: AZD7798A total of 2 subjects will receive AZD7798 on day 1 followed by placebo on day 15. |
| Placebo: Part 1a and Part 1b | Experimental | Biological: PlaceboA total of 2 subjects per cohort will receive placebo. |
| Part 3a - Cohort 12: AZD7798 | Experimental | Biological: AZD7798A total of 6 subjects will receive single ascending doses of AZD7798. |
| Part 3b - Cohort 13: AZD7798 | Experimental | Biological: AZD7798A total of 6 subjects will receive single ascending doses of AZD7798. |
| Placebo: Part 3a and Part 3b | Experimental | Biological: PlaceboA total of 2 subjects per cohort will receive placebo. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (25 listed)
- 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.
Key exclusion criteria (40 listed)
- Part 1a (in case of dose escalation in patients) and Part 2 (Patients with Crohn's Disease):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD7798Subjects will receive AZD7798 as a single ascending dose or as a repeat dose. | Biological | Part 1a - Cohort 1: AZD7798 dose 1, Part 1a - Cohort 2: AZD7798 dose 2, Part 1a - Cohort 3: AZD7798 dose 3, Part 1a - Cohort 4: AZD7798 dose 4, Part 1a - Cohort 5: AZD7798 dose 5, Part 1a - Cohort 6: AZD7798 dose 6, Part 1a - Cohort 7: AZD7798 dose 7, Part 1a - Spare Cohort 9: AZD7798 dose 9, Part 1b - Cohort 8: AZD7798 dose 8, Part 2 - Cohort 10: AZD7798 + AZD7798, Part 2 - Cohort 11: Placebo + AZD7798, Part 2 - Cohort 12: AZD7798 + Placebo, Part 3a - Cohort 12: AZD7798, Part 3b - Cohort 13: AZD7798 |
| PlaceboSubjects will receive placebo matching the AZD7798 dose as a single ascending dose or as a repeat dose. | Biological | Placebo: Part 1a and Part 1b, Placebo: Part 3a and Part 3b |
Primary outcome
Number of participants with Adverse Events (AEs)
Time frame: Until follow-up (Day 85) or Early termination (ET)
The safety and tolerability of AZD7798 following administration of single ascending doses will be assessed.
16 secondary outcomes
Area under plasma concentration time curve from zero to infinity (AUCinf)
Time frame: Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
AUClast
Time frame: Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Maximum serum concentration (Cmax)
Time frame: Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Time to reach maximum serum concentration (tmax)
Time frame: Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Time to last measurable concentration (tlast)
Time frame: Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Terminal elimination half-life (t½λz)
Time frame: Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Systemic clearance (CL)
Time frame: Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Apparent total clearance (CL/F)
Time frame: Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Volume of distribution based on the terminal phase (Vz)
Time frame: Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Apparent volume of distribution based on terminal phase (Vz/F)
Time frame: Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Bioavailability (F)
Time frame: Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Volume of distribution at steady state (Vss)
Time frame: Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
AUClast/D
Time frame: Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
AUCinf/D
Time frame: Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Cmax/D
Time frame: Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Percentage of patients with antidrug antibodies (ADAs)
Time frame: Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- D9690C00001\_CSR synopsis\_RedactedLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD7798 in people with Healthy Subjects and Crohns Disease, run by AstraZeneca at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse Events (AEs) (time frame: Until follow-up (Day 85) or Early termination (ET)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.