Healthy ParticipantsPhase 1NCT06491550
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4144 as Well as the Impact of AZD4144 on the Pharmacokinetics of Rosuvastatin and Furosemide in Healthy Participants
A Phase 1 study testing AZD4144- Part A, AZD4144- Part B and Rosuvastatin and Furosemide- Part C in people with Healthy Participants, run by AstraZeneca at 2 sites in United States.
Trial summary
This study consists of 3 parts: Part A, Part B and Part C. This study will compare the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD4144 with placebo in healthy participants, in Part A and Part B. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- AZD4144- Part A, AZD4144- Part B and Rosuvastatin and Furosemide- Part C
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jul 2024to 11 Jun 2025
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
- Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception.
- Females of non-childbearing potential must be confirmed at the Screening Visit.
- Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.
- Have a BMI between 18 and 32 kg/m2 inclusive at both Screening and Admission and weigh at least 45 kg at Screening.
- For healthy Japanese cohorts (Part A2 and Part B2): healthy male and female participants are to be Japanese, defined as having both parents and 4 grandparents who are Japanese. This includes second and third generation participants of Japanese descent whose parents or grandparents are living in a country other than Japan.
- For healthy Chinese cohort (Part A3): healthy male and female Chinese participants for whom both parents and all grandparents are Chinese and not lived outside of China for more than 10 years.
Who cannot join
- History of any clinically important disease or disorder or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically important illness, medical/surgical procedure, or trauma.
- Clinically significant serious active and chronic infections.
- Any history or evidence of TB (active or latent).
- Known history of primary immunodeficiency (congenital or acquired) or an underlying condition that predisposes to infection.
- Bacillus Calmette Guérin vaccine within one year prior to signing the ICF.
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- Any abnormal laboratory values at the Screening Visit or on Admission to the Clinical Unit.
- Any positive result on Screening for serum Hepatitis B surface antigen (HBsAg), anti-Hepatitis B core (HBc), hepatitis C antibody, or Human immunodeficiency virus (HIV).
- Any clinically important abnormalities in ECG.
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
- Known hypersensitivity to furosemide and rosuvastatin (for Part C only)
- History of alcohol abuse or excessive intake of alcohol or current smokers or those who have smoked or used nicotine products.
- Use of drugs with enzyme inducing properties or of any prescribed or nonprescribed medication or of systemic hormonal contraceptives.
- Clinical signs and symptoms consistent with COVID-19.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Research Site
Brooklyn, Maryland, 21225
Research Site
Glendale, California, 91206
About this study
Official title: A Phase I Randomized, Single-blind, Placebo-controlled, and Sequential Group Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4144 Following Single and Multiple Ascending Doses Via Intravenous Administration, and an Open-label, 2-Period, 2-Sequence, Cross-over Study to Assess the Effects of Intravenous AZD4144 on Rosuvastatin and Furosemide Pharmacokinetics in Healthy Participants
This study consists of 3 parts: Part A, Part B and Part C. This study will compare the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD4144 with placebo in healthy participants, in Part A and Part B. Part C of this study will investigate the possibility of drug-drug interaction (DDI) between IV AZD4144 and oral rosuvastatin and furosemide by evaluating the PK of rosuvastatin and furosemide when administered alone and in combination with single IV dose of AZD4144
Read the detailed description
This is a Phase I, randomized study in healthy participants and consists of 3 parts; Part A, Part B and Part C. Part A and B are single-blind, placebo-controlled with single ascending dose (SAD) and multiple ascending dose (MAD) sequential group design, respectively. Part C is an open-label, 2-period, 2-sequence, cross-over design study. Part A and B of the study will assess the safety, tolerability, PK, and PD of AZD4144 solution for infusion compared with placebo while Part C will investigate the possibility of DDI between IV AZD4144 and oral rosuvastatin and furosemide by evaluating the PK of rosuvastatin and furosemide when administered alone and in combination with single IV dose of AZD4144
The study will comprise of:
- A screening period of maximum 28 days.
- A residential period which lasts from,
- Day -1 to Day 4 (single dose on Day 1) for Part A
- Day -1 to Day 15 (dosed on days 1, 4-12) for Part B
- Day -1 to Day 3 (dose on Day 1) and Day 9 to Day 12 (dose on Day 10) for Part C
- A final follow-up visit,
- On Day 10+3 for Part A
- On Day 20+3 for Part B and C
- Conditions
- Healthy Participants
- Being tested
- AZD4144- Part A, Placebo- Part A, AZD4144- Part B, Placebo- Part B, Rosuvastatin and Furosemide- Part C
- Keywords
- Pharmacokinetic (PK), Pharmacodynamic (PD), Drug-drug interaction (DDI), Single ascending dose (SAD), Multiple ascending dose (MAD)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD4144- Part ADrug
Part A: Participants will be administered a single dose of AZD4144 on Day 1 via Intravenous (IV) infusion.
Placebo- Part ADrug
Part A: Participants will be administered a single dose of placebo on Day 1 via IV infusion.
AZD4144- Part BDrug
Part B: Participants will be administered a single dose of AZD4144 on Day 1 and Day 12 via IV infusion.
Participants will be administered multiple doses of AZD4144 from Day 4 to Day 11 via IV infusion.
Placebo- Part BDrug
Part B: Participants will be administered a single dose of placebo on Day 1 and Day 12via IV infusion. Participants will be administered multiple doses of placebo from Day 4 to Day 11 via IV infusion.
Rosuvastatin and Furosemide- Part CDrug
Participants will be administered a single oral dose of 10 mg Rosuvastatin and 1 mg Furosemide.
Rosuvastatin, Furosemide, and AZD4144 Part CDrug
Participants will be administered a single oral dose of 10 mg Rosuvastatin, 1 mg Furosemide and a single dose of AZD4144 via IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Part A1-Cohort 1 | Experimental | Participants will receive one single ascending dose of AZD4144. Receives: Drug: AZD4144- Part A |
| Part A1- Cohort 2 | Experimental | Participants will receive one single ascending dose of AZD4144. Receives: Drug: AZD4144- Part A |
| Part A1-Cohort 3 | Experimental | Participants will receive one single ascending dose of AZD4144. Receives: Drug: AZD4144- Part A |
| Part A2-Japanese cohort 1 | Experimental | Participants will receive one single ascending dose of AZD4144. Receives: Drug: AZD4144- Part A |
| Part A2: Japanese Cohort 2 | Experimental | Participants will receive one single ascending dose of AZD4144. Receives: Drug: AZD4144- Part A |
| Part A3-Chinese Cohort | Experimental | Participants will receive one single ascending dose of AZD4144. Receives: Drug: AZD4144- Part A |
| Part B1- Cohort 1 | Experimental | Participants will receive multiple ascending doses of AZD4144. Receives: Drug: AZD4144- Part B |
| Part B1- Cohort 2 | Experimental | Participants will receive multiple ascending doses of AZD4144. Receives: Drug: AZD4144- Part B |
| Part B1- Cohort 3 | Experimental | Participants will receive multiple ascending doses of AZD4144. Receives: Drug: AZD4144- Part B |
| Part B2- Japanese Cohort | Experimental | Participants will receive multiple ascending doses of AZD4144. Receives: Drug: AZD4144- Part B |
| Part C Cohort- Treatment C1 | Experimental | Participants will receive rosuvastatin and furosemide. Receives: Drug: Rosuvastatin and Furosemide- Part C |
| Part C cohort- Treatment C2 | Experimental | Participants will receive rosuvastatin, furosemide, and AZD4144. Receives: Drug: Rosuvastatin, Furosemide, and AZD4144 Part C |
| Part A1- Placebo | Placebo comparator | Participants will receive matching placebo. Receives: Drug: Placebo- Part A |
| Part A2- Placebo | Placebo comparator | Participants will receive matching placebo. Receives: Drug: Placebo- Part A |
| Part A3- Placebo | Placebo comparator | Participants will receive matching Placebo. Receives: Drug: Placebo- Part A |
| Part B1- Placebo | Placebo comparator | Participants will receive matching Placebo. Receives: Drug: Placebo- Part B |
| Part B2- Placebo | Placebo comparator | Participants will receive matching Placebo. Receives: Drug: Placebo- Part B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs) (Part A and Part B)
To assess the safety and tolerability of AZD4144 following IV administration of single (Part A) and multiple (Part B) ascending doses in healthy participants.
Measured: Part A: Day 1 to Day 10+3; Part B: Day 1 to Day 20+3.
Area under plasma concentration-time curve from time 0 to infinity (AUCinf) (Part C)
To evaluate the effect of AZD4144 on the PK of rosuvastatin and furosemide in healthy participants.
Measured: Treatment period 1: Day 1 to 3; Treatment period 2: Day 10 to 12.
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) (Part C)
To evaluate the effect of AZD4144 on the PK of rosuvastatin and furosemide in healthy participants.
Measured: Treatment period 1: Day 1 to 3; Treatment period 2: Day 10 to 12.
Maximum observed drug concentration (Cmax) (Part C)
To evaluate the effect of AZD4144 on the PK of rosuvastatin and furosemide in healthy participants.
Measured: Treatment period 1: Day 1 to 3; Treatment period 2: Day 10 to 12.
Secondary outcomes (7)
Cmax (Part A and Part B)
To characterize the PK of AZD4144 following IV administration of single (Part A) and multiple (Part B) ascending doses.
Measured: Part A: Day 1 to Day 10+3; Part B: Day 1 to Day 20+3
AUClast (Part A and Part B)
To characterize the PK of AZD4144 following IV administration of single (Part A) and multiple (Part B) ascending doses
Measured: Part A: Day 1 to Day 10+3; Part B: Day 1 to Day 20+3
AUCinf (Part A)
To characterize the PK of AZD4144 following IV administration of single (Part A) ascending doses.
Measured: Part A: Day 1 to Day 10+3
Area under concentration-time curve in the dosing interval (AUCτ) (Part B only)
To characterize the PK of AZD4144 following IV administration of multiple (Part B) ascending doses
Measured: Part B: Day 1 to Day 20+3
Renal clearance of drug from plasma (CLR) (Part A and Part B)
To characterize the PK of AZD4144 following IV administration of single (Part A) and multiple (Part B) ascending doses.
Measured: Part A: Day 1 to 3; Part B: Day 1, 12 and 20+3
PD analysis: Levels of disease-specific biomarkers (Part A and Part B)
To assess the effect of AZD4144 on levels of disease-specific biomarkers. (Part A and Part B)
Measured: Part A: Day -1 to 4; Part B: Day -1 to Day 1, Day 12 to Day 15
Number of participants with adverse events (AEs) (Part C)
To assess the safety and tolerability of AZD4144 in combination with rosuvastatin and furosemide in healthy participants.
Measured: Part C: Day 1 to Day 20+3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start15 Jul 2024
- Primary completion11 Jun 2025
- Study completion11 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491550
- Sponsor's protocol ID
- D9440C00002
- Status last verified
- Jun 2025
- First submitted
- 1 Jul 2024
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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 Vivli.org. All requests 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 approved.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Randomized, Single-blind, Placebo-controlled, and Sequential Group Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4144 Following Single and Multiple Ascending Doses Via Intravenous Administration, and an Open-label, 2-Period, 2-Sequence, Cross-over Study to Assess the Effects of Intravenous AZD4144 on Rosuvastatin and Furosemide Pharmacokinetics in Healthy Participants
- ClinicalTrials.gov ID
- NCT06491550
- Acronym / sponsor ID
- D9440C00002
- Conditions
- Healthy Participants
- Keywords
- Pharmacokinetic (PK), Pharmacodynamic (PD), Drug-drug interaction (DDI), Single ascending dose (SAD), Multiple ascending dose (MAD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 11 Jun 2025 (actual)
- Study completion
- 11 Jun 2025 (actual)
- First posted
- 9 Jul 2024 (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 consists of 3 parts: Part A, Part B and Part C. This study will compare the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD4144 with placebo in healthy participants, in Part A and Part B. Part C of this study will investigate the possibility of drug-drug interaction (DDI) between IV AZD4144 and oral rosuvastatin and furosemide by evaluating the PK of rosuvastatin and furosemide when administered alone and in combination with single IV dose of AZD4144
Detailed description
This is a Phase I, randomized study in healthy participants and consists of 3 parts; Part A, Part B and Part C. Part A and B are single-blind, placebo-controlled with single ascending dose (SAD) and multiple ascending dose (MAD) sequential group design, respectively. Part C is an open-label, 2-period, 2-sequence, cross-over design study. Part A and B of the study will assess the safety, tolerability, PK, and PD of AZD4144 solution for infusion compared with placebo while Part C will investigate the possibility of DDI between IV AZD4144 and oral rosuvastatin and furosemide by evaluating the PK of rosuvastatin and furosemide when administered alone and in combination with single IV dose of AZD4144
The study will comprise of:
- A screening period of maximum 28 days.
- A residential period which lasts from,
- Day -1 to Day 4 (single dose on Day 1) for Part A
- Day -1 to Day 15 (dosed on days 1, 4-12) for Part B
- Day -1 to Day 3 (dose on Day 1) and Day 9 to Day 12 (dose on Day 10) for Part C
- A final follow-up visit,
- On Day 10+3 for Part A
- On Day 20+3 for Part B and C
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 17
| Arm | Type | Receives |
|---|---|---|
| Part A1-Cohort 1 | Experimental | Drug: AZD4144- Part AParticipants will receive one single ascending dose of AZD4144. |
| Part A1- Cohort 2 | Experimental | Drug: AZD4144- Part AParticipants will receive one single ascending dose of AZD4144. |
| Part A1-Cohort 3 | Experimental | Drug: AZD4144- Part AParticipants will receive one single ascending dose of AZD4144. |
| Part A2-Japanese cohort 1 | Experimental | Drug: AZD4144- Part AParticipants will receive one single ascending dose of AZD4144. |
| Part A2: Japanese Cohort 2 | Experimental | Drug: AZD4144- Part AParticipants will receive one single ascending dose of AZD4144. |
| Part A3-Chinese Cohort | Experimental | Drug: AZD4144- Part AParticipants will receive one single ascending dose of AZD4144. |
| Part B1- Cohort 1 | Experimental | Drug: AZD4144- Part BParticipants will receive multiple ascending doses of AZD4144. |
| Part B1- Cohort 2 | Experimental | Drug: AZD4144- Part BParticipants will receive multiple ascending doses of AZD4144. |
| Part B1- Cohort 3 | Experimental | Drug: AZD4144- Part BParticipants will receive multiple ascending doses of AZD4144. |
| Part B2- Japanese Cohort | Experimental | Drug: AZD4144- Part BParticipants will receive multiple ascending doses of AZD4144. |
| Part C Cohort- Treatment C1 | Experimental | Drug: Rosuvastatin and Furosemide- Part CParticipants will receive rosuvastatin and furosemide. |
| Part C cohort- Treatment C2 | Experimental | Drug: Rosuvastatin, Furosemide, and AZD4144 Part CParticipants will receive rosuvastatin, furosemide, and AZD4144. |
| Part A1- Placebo | Placebo comparator | Drug: Placebo- Part AParticipants will receive matching placebo. |
| Part A2- Placebo | Placebo comparator | Drug: Placebo- Part AParticipants will receive matching placebo. |
| Part A3- Placebo | Placebo comparator | Drug: Placebo- Part AParticipants will receive matching Placebo. |
| Part B1- Placebo | Placebo comparator | Drug: Placebo- Part BParticipants will receive matching Placebo. |
| Part B2- Placebo | Placebo comparator | Drug: Placebo- Part BParticipants will receive matching Placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
- Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception.
- Females of non-childbearing potential must be confirmed at the Screening Visit.
- Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.
- Have a BMI between 18 and 32 kg/m2 inclusive at both Screening and Admission and weigh at least 45 kg at Screening.
Key exclusion criteria (14 listed)
- History of any clinically important disease or disorder or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically important illness, medical/surgical procedure, or trauma.
- Clinically significant serious active and chronic infections.
- Any history or evidence of TB (active or latent).
- Known history of primary immunodeficiency (congenital or acquired) or an underlying condition that predisposes to infection.
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 |
|---|---|---|
| AZD4144- Part APart A: Participants will be administered a single dose of AZD4144 on Day 1 via Intravenous (IV) infusion. | Drug | Part A1- Cohort 2, Part A1-Cohort 1, Part A1-Cohort 3, Part A2-Japanese cohort 1, Part A2: Japanese Cohort 2, Part A3-Chinese Cohort |
| Placebo- Part APart A: Participants will be administered a single dose of placebo on Day 1 via IV infusion. | Drug | Part A1- Placebo, Part A2- Placebo, Part A3- Placebo |
| AZD4144- Part BPart B: Participants will be administered a single dose of AZD4144 on Day 1 and Day 12 via IV infusion. Participants will be administered multiple doses of AZD4144 from Day 4 to Day 11 via IV infusion. | Drug | Part B1- Cohort 1, Part B1- Cohort 2, Part B1- Cohort 3, Part B2- Japanese Cohort |
| Placebo- Part BPart B: Participants will be administered a single dose of placebo on Day 1 and Day 12via IV infusion. Participants will be administered multiple doses of placebo from Day 4 to Day 11 via IV infusion. | Drug | Part B1- Placebo, Part B2- Placebo |
| Rosuvastatin and Furosemide- Part CParticipants will be administered a single oral dose of 10 mg Rosuvastatin and 1 mg Furosemide. | Drug | Part C Cohort- Treatment C1 |
| Rosuvastatin, Furosemide, and AZD4144 Part CParticipants will be administered a single oral dose of 10 mg Rosuvastatin, 1 mg Furosemide and a single dose of AZD4144 via IV infusion. | Drug | Part C cohort- Treatment C2 |
Primary outcome
Number of participants with adverse events (AEs) (Part A and Part B)
Time frame: Part A: Day 1 to Day 10+3; Part B: Day 1 to Day 20+3.
To assess the safety and tolerability of AZD4144 following IV administration of single (Part A) and multiple (Part B) ascending doses in healthy participants.
Area under plasma concentration-time curve from time 0 to infinity (AUCinf) (Part C)
Time frame: Treatment period 1: Day 1 to 3; Treatment period 2: Day 10 to 12.
To evaluate the effect of AZD4144 on the PK of rosuvastatin and furosemide in healthy participants.
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) (Part C)
Time frame: Treatment period 1: Day 1 to 3; Treatment period 2: Day 10 to 12.
To evaluate the effect of AZD4144 on the PK of rosuvastatin and furosemide in healthy participants.
Maximum observed drug concentration (Cmax) (Part C)
Time frame: Treatment period 1: Day 1 to 3; Treatment period 2: Day 10 to 12.
To evaluate the effect of AZD4144 on the PK of rosuvastatin and furosemide in healthy participants.
7 secondary outcomes
Cmax (Part A and Part B)
Time frame: Part A: Day 1 to Day 10+3; Part B: Day 1 to Day 20+3
AUClast (Part A and Part B)
Time frame: Part A: Day 1 to Day 10+3; Part B: Day 1 to Day 20+3
AUCinf (Part A)
Time frame: Part A: Day 1 to Day 10+3
Area under concentration-time curve in the dosing interval (AUCτ) (Part B only)
Time frame: Part B: Day 1 to Day 20+3
Renal clearance of drug from plasma (CLR) (Part A and Part B)
Time frame: Part A: Day 1 to 3; Part B: Day 1, 12 and 20+3
PD analysis: Levels of disease-specific biomarkers (Part A and Part B)
Time frame: Part A: Day -1 to 4; Part B: Day -1 to Day 1, Day 12 to Day 15
Number of participants with adverse events (AEs) (Part C)
Time frame: Part C: Day 1 to Day 20+3
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 4 Jul 2025.
- 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 Vivli.org. All requests 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 approved.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD4144- Part A, AZD4144- Part B and Rosuvastatin and Furosemide- Part C in people with Healthy Participants, run by AstraZeneca at 2 sites in United States.
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 7 inclusion and 14 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 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. Some participants in this study may receive a placebo. 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) (Part A and Part B) (time frame: Part A: Day 1 to Day 10+3; Part B: Day 1 to Day 20+3.). The study lists 4 primary outcomes in all. 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 4 Jul 2025.