NCT07069725 The Phase 1, Open-label, PET Trial Designed to Investigate the Effect of AZD2389 on FAP Occupancy in the Liver in Participants With Advanced Liver Fibrosis.
| NCT ID | NCT07069725 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | AstraZeneca |
| Condition | Liver Fibrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2025-05-26 |
| Primary Completion | 2026-07-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2025-05-26 with a primary completion date of 2026-07-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a phase 1, open-label, PET trial. The study is designed to investigate the effect of AZD2389 on FAP occupancy in the liver in participants with advanced liver fibrosis.
Eligibility Criteria
Key Inclusion Criteria: 1. Male or female (of non-childbearing potential) participant aged ≥ 20 years and willing and able to give written informed consent for participation in the trial. 2. History confirming compensated liver cirrhosis. 3. Females must have a negative pregnancy test. 4. Barrier contraceptives use by males. Key Exclusion Criteria: 1. A condition that would interfere with evaluation of the trial intervention, put the participant at risk, influence the participant's ability to participate or affect the interpretation of the results of the trial. 2. Any clinically significant illness, medical or major surgical procedure or trauma prior randomization. 3. Hepatitis B , hepatitis C and/or HIV infection. 4. Significant elevations in liver blood test, MELD score \>12 and platelets \<100 x109/L g). 5. eGFR) \< 60 ml/min/1.73m2. 6. History of decompensated liver cirrhosis. 7. Any participants with an aetiology of liver cirrhosis where the Investigator considers that PET signal uptake may be impacted. 8. History of bleeding disorders and major bleeding risk. 9. History of severe dermatological disorders or wound healing. 10. Positive screening result for drugs of abuse or alcohol.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07069725 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Liver Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07069725 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07069725 currently recruiting?
Yes, NCT07069725 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT07069725 trial being conducted?
This trial is being conducted at Solna, Sweden, Stockholm, Sweden.
Who is sponsoring the NCT07069725 clinical trial?
NCT07069725 is sponsored by AstraZeneca. The trial plans to enroll 12 participants.