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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

Primary Purpose

Healthy Subjects, Crohns Disease

Status
Recruiting
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
AZD7798
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy Subjects focused on measuring AZD7798, Single ascending dose, Repeat dose, Sentinel dosing

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Provision of signed and dated, written informed consent prior to any study specific procedures.
  • Healthy male and female (of childbearing and non childbearing potential) subjects aged 18 to 50 years inclusive.
  • 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.
  • 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.

Exclusion Criteria:

  • History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study, ie, history of any clinically significant disease suggesting immunodeficiency or abnormal immune function or history or presence of clinically significant gastrointestinal (GI), hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of monoclonal antibodies.
  • Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of Investigational Medicinal Product (IMP).
  • Selected laboratory values with deviations.
  • Any clinically important abnormalities in clinical chemistry, haematology, or urinalysis results.
  • Any positive result on Screening for Hepatitis B surface antigen (HBsAg), anti-Hepatitis B core (HBc) antibody, anti-Hepatitis C virus (HCV) antibody, and human immunodeficiency virus (HIV).
  • Abnormal vital signs after 5 minutes supine rest at screening and admission.
  • Any clinically important abnormalities in rhythm, conduction or morphology of the electrocardiogram (ECG) after 10 minutes resting and any clinically important abnormalities in the 12 lead ECG that may interfere with the interpretation of Corrected QT interval (QTc) interval changes, including abnormal ST T wave morphology, particularly primary lead or left ventricular hypertrophy.
  • Known or suspected history of drug abuse in the last 2 years.
  • History of alcohol abuse or excessive intake of alcohol within the last 2 years.
  • 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.
  • 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.
  • Excessive intake of caffeine containing drinks or food.
  • Plasma donation within 1 month of the Screening Visit or any blood donation/blood loss > 500 mL during the 3 months prior to the Screening Visit.
  • Has received another new chemical entity within 30 days/5 half-lives of the first administration of IMP in this study.
  • Has received another new chemical entity within 3 months of the first administration of IMP in this study.
  • Any ongoing or recent minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions and, requirements.
  • Subjects who cannot communicate reliably with the Investigator.
  • Vulnerable subjects.

Sites / Locations

  • Research SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

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 1b - Cohort 8: AZD7798 dose 8

Part 1a - Spare Cohort 9: AZD7798 dose 9

Part 2 - Cohort 10: AZD7798 + AZD7798

Part 2 - Cohort 11: Placebo + AZD7798

Part 2 - Cohort 12: AZD7798 + Placebo

Placebo: Part 1a and Part 1b

Arm Description

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

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

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

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

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

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

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

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

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

A total of 4 subjects will receive a single dose on Day 1 followed by a single dose on Day 15.

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

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

A total of 2 subjects per cohort will receive placebo.

Outcomes

Primary Outcome Measures

Number of participants with Adverse Events (AEs)
The safety and tolerability of AZD7798 following administration of single ascending doses will be assessed.

Secondary Outcome Measures

Area under plasma concentration time curve from zero to infinity (AUCinf)
The AUCinf of AZD7798 following administration of single ascending doses will be assessed.
AUClast
The AUClast of AZD7798 following administration of single ascending doses will be assessed.
Maximum serum concentration (Cmax)
The Cmax of AZD7798 following administration of single ascending doses will be assessed.
Time to reach maximum serum concentration (tmax)
The tmax of AZD7798 following administration of single ascending doses will be assessed.
Time to last measurable concentration (tlast)
The tlast of AZD7798 following administration of single ascending doses will be assessed.
Terminal elimination half-life (t½λz)
The t½λz of AZD7798 following administration of single ascending doses will be assessed.
Systemic clearance (CL)
The CL of AZD7798 following administration of single ascending doses will be assessed.
Apparent total clearance (CL/F)
The CL/F of AZD7798 following administration of single ascending doses will be assessed.
Volume of distribution based on the terminal phase (Vz)
The Vz of AZD7798 following administration of single ascending doses will be assessed.
Apparent volume of distribution based on terminal phase (Vz/F)
The Vz/F of AZD7798 following administration of single ascending doses will be assessed.
Bioavailability (F)
The F of AZD7798 following administration of single ascending doses will be assessed.
Volume of distribution at steady state (Vss)
The Vss of AZD7798 following administration of single ascending doses will be assessed.
AUClast/D
The AUClast/D of AZD7798 following administration of single ascending doses will be assessed.
AUCinf/D
The AUCinf/D of AZD7798 following administration of single ascending doses will be assessed.
Cmax/D
The Cmax/D of AZD7798 following administration of single ascending doses will be assessed.
Percentage of patients with antidrug antibodies (ADAs)
The immunogenicity of AZD7798 following administration of single ascending doses will be assessed.

Full Information

First Posted
July 6, 2022
Last Updated
September 29, 2023
Sponsor
AstraZeneca
Collaborators
Parexel
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1. Study Identification

Unique Protocol Identification Number
NCT05452304
Brief Title
AZD7798 Safety, Tolerability, and Pharmacokinetics After a Single Ascending and Repeat Dose Administrations to Healthy Subjects, and Patients With Crohn's Disease
Official Title
A Phase 1 Randomised, Double-Blind, Placebo-Controlled 2 Part Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7798 Following Single Ascending Dose Administration and Repeat Dose Administration in Healthy Subjects and Patients With Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2022 (Actual)
Primary Completion Date
May 10, 2024 (Anticipated)
Study Completion Date
May 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Parexel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 2 parts: Part 1 (sub-parts 1a and 1b) and Part 2. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Subjects, Crohns Disease
Keywords
AZD7798, Single ascending dose, Repeat dose, Sentinel dosing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 1a - Cohort 1: AZD7798 dose 1
Arm Type
Experimental
Arm Description
A total of 6 subjects will receive single ascending doses of AZD7798.
Arm Title
Part 1a - Cohort 2: AZD7798 dose 2
Arm Type
Experimental
Arm Description
A total of 6 subjects will receive single ascending doses of AZD7798.
Arm Title
Part 1a - Cohort 3: AZD7798 dose 3
Arm Type
Experimental
Arm Description
A total of 6 subjects will receive single ascending doses of AZD7798.
Arm Title
Part 1a - Cohort 4: AZD7798 dose 4
Arm Type
Experimental
Arm Description
A total of 6 subjects will receive single ascending doses of AZD7798.
Arm Title
Part 1a - Cohort 5: AZD7798 dose 5
Arm Type
Experimental
Arm Description
A total of 6 subjects will receive single ascending doses of AZD7798.
Arm Title
Part 1a - Cohort 6: AZD7798 dose 6
Arm Type
Experimental
Arm Description
A total of 6 subjects will receive single ascending doses of AZD7798.
Arm Title
Part 1a - Cohort 7: AZD7798 dose 7
Arm Type
Experimental
Arm Description
A total of 6 subjects will receive single ascending doses of AZD7798.
Arm Title
Part 1b - Cohort 8: AZD7798 dose 8
Arm Type
Experimental
Arm Description
A total of 6 subjects will receive repeat doses of AZD7798.
Arm Title
Part 1a - Spare Cohort 9: AZD7798 dose 9
Arm Type
Experimental
Arm Description
A total of 6 subjects will receive a single ascending dose of AZD7798.
Arm Title
Part 2 - Cohort 10: AZD7798 + AZD7798
Arm Type
Experimental
Arm Description
A total of 4 subjects will receive a single dose on Day 1 followed by a single dose on Day 15.
Arm Title
Part 2 - Cohort 11: Placebo + AZD7798
Arm Type
Experimental
Arm Description
A total of 2 subjects will receive placebo on day 1 followed by AZD7798 on day 15.
Arm Title
Part 2 - Cohort 12: AZD7798 + Placebo
Arm Type
Experimental
Arm Description
A total of 2 subjects will receive AZD7798 on day 1 followed by placebo on day 15.
Arm Title
Placebo: Part 1a and Part 1b
Arm Type
Experimental
Arm Description
A total of 2 subjects per cohort will receive placebo.
Intervention Type
Biological
Intervention Name(s)
AZD7798
Intervention Description
Subjects will receive AZD7798 as a single ascending dose or as a repeat dose.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Subjects will receive placebo matching the AZD7798 dose as a single ascending dose or as a repeat dose.
Primary Outcome Measure Information:
Title
Number of participants with Adverse Events (AEs)
Description
The safety and tolerability of AZD7798 following administration of single ascending doses will be assessed.
Time Frame
Until follow-up (Day 85) or Early termination (ET)
Secondary Outcome Measure Information:
Title
Area under plasma concentration time curve from zero to infinity (AUCinf)
Description
The AUCinf of AZD7798 following administration of single ascending doses will be assessed.
Time Frame
Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Title
AUClast
Description
The AUClast of AZD7798 following administration of single ascending doses will be assessed.
Time Frame
Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Title
Maximum serum concentration (Cmax)
Description
The Cmax of AZD7798 following administration of single ascending doses will be assessed.
Time Frame
Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Title
Time to reach maximum serum concentration (tmax)
Description
The tmax of AZD7798 following administration of single ascending doses will be assessed.
Time Frame
Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Title
Time to last measurable concentration (tlast)
Description
The tlast of AZD7798 following administration of single ascending doses will be assessed.
Time Frame
Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Title
Terminal elimination half-life (t½λz)
Description
The t½λz of AZD7798 following administration of single ascending doses will be assessed.
Time Frame
Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Title
Systemic clearance (CL)
Description
The CL of AZD7798 following administration of single ascending doses will be assessed.
Time Frame
Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Title
Apparent total clearance (CL/F)
Description
The CL/F of AZD7798 following administration of single ascending doses will be assessed.
Time Frame
Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Title
Volume of distribution based on the terminal phase (Vz)
Description
The Vz of AZD7798 following administration of single ascending doses will be assessed.
Time Frame
Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Title
Apparent volume of distribution based on terminal phase (Vz/F)
Description
The Vz/F of AZD7798 following administration of single ascending doses will be assessed.
Time Frame
Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Title
Bioavailability (F)
Description
The F of AZD7798 following administration of single ascending doses will be assessed.
Time Frame
Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Title
Volume of distribution at steady state (Vss)
Description
The Vss of AZD7798 following administration of single ascending doses will be assessed.
Time Frame
Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Title
AUClast/D
Description
The AUClast/D of AZD7798 following administration of single ascending doses will be assessed.
Time Frame
Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Title
AUCinf/D
Description
The AUCinf/D of AZD7798 following administration of single ascending doses will be assessed.
Time Frame
Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Title
Cmax/D
Description
The Cmax/D of AZD7798 following administration of single ascending doses will be assessed.
Time Frame
Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85
Title
Percentage of patients with antidrug antibodies (ADAs)
Description
The immunogenicity of AZD7798 following administration of single ascending doses will be assessed.
Time Frame
Day 1 to Day 8, and Days 15, 22, 29, 43, 57, and 85

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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): • 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. 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. 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): 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AstraZeneca Clinical Study Information Center
Phone
1-877-240-9479
Email
information.center@astrazeneca.com
Facility Information:
Facility Name
Research Site
City
Harrow
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home

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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

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