Healthy ParticipantsPhase 1NCT06122714
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4144 Following Single and Multiple Ascending Doses Via Oral Administration to Healthy Participants
A Phase 1 study testing AZD4144 Part A and AZD4144 Part B in people with Healthy Participants, run by AstraZeneca at 2 sites in United States.
Trial summary
This study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of AZD4144 administered orally in healthy participants. 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 and AZD4144 Part B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Nov 2023to 4 Dec 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females must have a negative pregnancy test, must not be lactating and must be of non-childbearing potential.
- 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 (of non-childbearing potential) participants are to be Japanese, defined as having both parents and four grandparents who are Japanese. This included 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 (of non-childbearing potential) 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 which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study.
- History 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.
- Bacillus Calmette-Guérin vaccine within one year prior to signing the ICF.
- Any abnormal laboratory values at the Screening Visit.
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- 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 cardiac abnormalities.
- History of alcohol abuse or drug abuse.
- Current smokers or those who have smoked or used nicotine products.
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
- Clinical signs and symptoms consistent with COVID-19.
- In addition, any of the following is regarded as a criterion for exclusion from the genetic research:
- Previous bone marrow transplant
- Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection
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 Randomised, 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 Oral Administration to Healthy Participants
This study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of AZD4144 administered orally in healthy participants.
Read the detailed description
This is a Phase I, first time-in human (FTiH), randomised, single-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) sequential group study in healthy participants.
Part A consists of 3 parts:
Part A1 (healthy participants) Part A2 (healthy Japanese participants) and Part A3 (healthy Chinese participants)
Part B consists of 2 parts:
Part B1 (healthy participants) Part B2 (healthy Japanese participants)
Both Part A and Part B of the study will comprise of a screening period of maximum 28 days. The treatment period would last from Day -1 to Day 4 in Part A and from Day -1 to Day 15 in Part B of the study. A follow up visit will be performed on Day 10 + 3 days for Part A and on Day 20 + 3 days for Part B.
Each participant will participate for about 6 weeks in Part A of the study and for about 7 weeks in Part B of the study.
- Conditions
- Healthy Participants
- Being tested
- AZD4144 Part A, AZD4144 Part B, Placebo Part A, Placebo Part B
- Keywords
- 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 oral dose on Day 1.
AZD4144 Part BDrug
Part B: Participants will be administered a single dose on Day 1, and repeated dosing will commence from Day 4 until Day 11 (inclusive) and a single dose on Day 12.
Placebo Part ADrug
Part A: Participants will be administered a single oral dose of matching placebo on Day 1.
Placebo Part BDrug
Part B: Participants will be administered a single dose of matching placebo on Day 1, and repeated dosing will commence from Day 4 until Day 11 (inclusive) and a single dose on Day 12.
| Study group | Role | What they receive |
|---|---|---|
| Part A1 (healthy participants) Cohort 1 | Experimental | Participants will receive one single ascending dose of AZD4144. Receives: Drug: AZD4144 Part A |
| Part A1 (healthy participants) Cohort 2 | Experimental | Participants will receive one single ascending dose of AZD4144. Receives: Drug: AZD4144 Part A |
| Part A1 (healthy participants) Cohort 3 | Experimental | Participants will receive one single ascending dose of AZD4144. Receives: Drug: AZD4144 Part A |
| Part A1 (healthy participants) Cohort 4 | Experimental | Participants will receive one single ascending dose of AZD4144. Receives: Drug: AZD4144 Part A |
| Part A1 (healthy participants) Cohort 5 | Experimental | Participants will receive one single ascending dose of AZD4144. Receives: Drug: AZD4144 Part A |
| Part A1 (healthy participants) Cohort 6 | Experimental | Participants will receive one single ascending dose of AZD4144. Receives: Drug: AZD4144 Part A |
| Part A1 (healthy participants) placebo | Placebo comparator | Participants will receive matching Placebo. Receives: Drug: Placebo Part A |
| Part A2 (healthy Japanese participants) Cohort 1 | Experimental | Participants will receive one single ascending dose of AZD4144. Receives: Drug: AZD4144 Part A |
| Part A2 (healthy Japanese participants) Cohort 2 | Experimental | Participants will receive one single ascending dose of AZD4144. Receives: Drug: AZD4144 Part A |
| Part A2 (healthy Japanese participants) placebo | Placebo comparator | Participants will receive matching placebo. Receives: Drug: Placebo Part A |
| Part A3 (healthy Chinese participants) Cohort 1 | Experimental | Participants will receive one single ascending dose of AZD4144. Receives: Drug: AZD4144 Part A |
| Part A3 (healthy Chinese participants) placebo | Placebo comparator | Participants will receive matching placebo. Receives: Drug: Placebo Part A |
| Part B1 (healthy participants) Cohort 1 | Experimental | Participants will receive one multiple ascending dose of AZD4144. Receives: Drug: AZD4144 Part B |
| Part B1 (healthy participants) Cohort 2 | Experimental | Participants will receive one multiple ascending dose of AZD4144. Receives: Drug: AZD4144 Part B |
| Part B1 (healthy participants) Cohort 3 | Experimental | Participants will receive one multiple ascending dose of AZD4144. Receives: Drug: AZD4144 Part B |
| Part B1 (healthy participants) placebo | Placebo comparator | Participants will receive matching placebo. Receives: Drug: Placebo Part B |
| Part B2 (healthy Japanese participants) Cohort 1 | Experimental | Participants will receive one multiple ascending dose of AZD4144. Receives: Drug: AZD4144 Part B |
| Part B2 (healthy Japanese participants) 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)
To assess the safety and tolerability of AZD4144 following oral administration of single and multiple ascending doses (Part A and Part B)
Measured: Part A: From screening (Day -28 to Day -2) to Day 10; Part B: From screening (Day -28 to Day-2) to Day 20
Secondary outcomes (5)
Maximum observed plasma (peak) drug concentration (Cmax)
To characterise the single dose and steady state PK of AZD4144 following oral administration of single and multiple ascending doses (Part A and Part B).
Measured: Part A: Day 1 to Day 4. and Day 10; Part B: Day 1 to Day 15 and Day 20
Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast)
To characterise the single dose and steady state PK of AZD4144 following oral administration of single and multiple ascending doses (Part A and Part B)
Measured: Part A: Day 1 to Day 4. and Day 10; Part B: Day 1 to Day 15 and Day 20
Area under plasma concentration-time curve from zero to infinity (AUC0-inf)
To characterise the single dose and steady state PK of AZD4144 following oral administration of single and multiple ascending doses (Part A and Part B)
Measured: Part A: Day 1 to Day 4. and Day 10; Part B: Day 1 to Day 15 and Day 20
Renal clearance of drug from plasma (CLR)
To characterise the single dose and steady state PK of AZD4144 following oral administration of single and multiple ascending doses (Part A and Part B)
Measured: Part A: Day 1 to Day 4. and Day 10; Part B: Day 1 to Day 15 and Day 20
PD analysis: Levels of disease-specific biomarkers
To assess the effect of AZD4144 on levels of disease-specific biomarkers.
Measured: Part A: Day 1 to Day 4 and Day 10; Part B: Day -1, Day 1 to Day 4, Day 12 to Day 15 and Day 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start7 Nov 2023
- Primary completion4 Dec 2024
- Study completion4 Dec 2024
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 95 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
- NCT06122714
- Sponsor's protocol ID
- D9440C00001
- Status last verified
- Dec 2024
- First submitted
- 3 Nov 2023
- Last updated
- 13 Dec 2024
- 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 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Randomised, 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 Oral Administration to Healthy Participants
- ClinicalTrials.gov ID
- NCT06122714
- Acronym / sponsor ID
- D9440C00001
- Conditions
- Healthy Participants
- Keywords
- Single ascending dose (SAD), Multiple ascending dose (MAD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 4 Dec 2024 (actual)
- Study completion
- 4 Dec 2024 (actual)
- First posted
- 8 Nov 2023 (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 evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of AZD4144 administered orally in healthy participants.
Detailed description
This is a Phase I, first time-in human (FTiH), randomised, single-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) sequential group study in healthy participants.
Part A consists of 3 parts:
Part A1 (healthy participants) Part A2 (healthy Japanese participants) and Part A3 (healthy Chinese participants)
Part B consists of 2 parts:
Part B1 (healthy participants) Part B2 (healthy Japanese participants)
Both Part A and Part B of the study will comprise of a screening period of maximum 28 days. The treatment period would last from Day -1 to Day 4 in Part A and from Day -1 to Day 15 in Part B of the study. A follow up visit will be performed on Day 10 + 3 days for Part A and on Day 20 + 3 days for Part B.
Each participant will participate for about 6 weeks in Part A of the study and for about 7 weeks in Part B of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 18
| Arm | Type | Receives |
|---|---|---|
| Part A1 (healthy participants) Cohort 1 | Experimental | Drug: AZD4144 Part AParticipants will receive one single ascending dose of AZD4144. |
| Part A1 (healthy participants) Cohort 2 | Experimental | Drug: AZD4144 Part AParticipants will receive one single ascending dose of AZD4144. |
| Part A1 (healthy participants) Cohort 3 | Experimental | Drug: AZD4144 Part AParticipants will receive one single ascending dose of AZD4144. |
| Part A1 (healthy participants) Cohort 4 | Experimental | Drug: AZD4144 Part AParticipants will receive one single ascending dose of AZD4144. |
| Part A1 (healthy participants) Cohort 5 | Experimental | Drug: AZD4144 Part AParticipants will receive one single ascending dose of AZD4144. |
| Part A1 (healthy participants) Cohort 6 | Experimental | Drug: AZD4144 Part AParticipants will receive one single ascending dose of AZD4144. |
| Part A1 (healthy participants) placebo | Placebo comparator | Drug: Placebo Part AParticipants will receive matching Placebo. |
| Part A2 (healthy Japanese participants) Cohort 1 | Experimental | Drug: AZD4144 Part AParticipants will receive one single ascending dose of AZD4144. |
| Part A2 (healthy Japanese participants) Cohort 2 | Experimental | Drug: AZD4144 Part AParticipants will receive one single ascending dose of AZD4144. |
| Part A2 (healthy Japanese participants) placebo | Placebo comparator | Drug: Placebo Part AParticipants will receive matching placebo. |
| Part A3 (healthy Chinese participants) Cohort 1 | Experimental | Drug: AZD4144 Part AParticipants will receive one single ascending dose of AZD4144. |
| Part A3 (healthy Chinese participants) placebo | Placebo comparator | Drug: Placebo Part AParticipants will receive matching placebo. |
| Part B1 (healthy participants) Cohort 1 | Experimental | Drug: AZD4144 Part BParticipants will receive one multiple ascending dose of AZD4144. |
| Part B1 (healthy participants) Cohort 2 | Experimental | Drug: AZD4144 Part BParticipants will receive one multiple ascending dose of AZD4144. |
| Part B1 (healthy participants) Cohort 3 | Experimental | Drug: AZD4144 Part BParticipants will receive one multiple ascending dose of AZD4144. |
| Part B1 (healthy participants) placebo | Placebo comparator | Drug: Placebo Part BParticipants will receive matching placebo. |
| Part B2 (healthy Japanese participants) Cohort 1 | Experimental | Drug: AZD4144 Part BParticipants will receive one multiple ascending dose of AZD4144. |
| Part B2 (healthy Japanese participants) 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 (4 listed)
- Females must have a negative pregnancy test, must not be lactating and must be of non-childbearing potential.
- 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 (of non-childbearing potential) participants are to be Japanese, defined as having both parents and four grandparents who are Japanese. This included 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 (of non-childbearing potential) Chinese participants for whom both parents and all grandparents are Chinese and not lived outside of China for more than 10 years.
Key exclusion criteria (15 listed)
- History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study.
- History 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.
- Bacillus Calmette-Guérin vaccine within one year prior to signing the ICF.
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 oral dose on Day 1. | Drug | Part A1 (healthy participants) Cohort 1, Part A1 (healthy participants) Cohort 2, Part A1 (healthy participants) Cohort 3, Part A1 (healthy participants) Cohort 4, Part A1 (healthy participants) Cohort 5, Part A1 (healthy participants) Cohort 6, Part A2 (healthy Japanese participants) Cohort 1, Part A2 (healthy Japanese participants) Cohort 2, Part A3 (healthy Chinese participants) Cohort 1 |
| AZD4144 Part BPart B: Participants will be administered a single dose on Day 1, and repeated dosing will commence from Day 4 until Day 11 (inclusive) and a single dose on Day 12. | Drug | Part B1 (healthy participants) Cohort 1, Part B1 (healthy participants) Cohort 2, Part B1 (healthy participants) Cohort 3, Part B2 (healthy Japanese participants) Cohort 1 |
| Placebo Part APart A: Participants will be administered a single oral dose of matching placebo on Day 1. | Drug | Part A1 (healthy participants) placebo, Part A2 (healthy Japanese participants) placebo, Part A3 (healthy Chinese participants) placebo |
| Placebo Part BPart B: Participants will be administered a single dose of matching placebo on Day 1, and repeated dosing will commence from Day 4 until Day 11 (inclusive) and a single dose on Day 12. | Drug | Part B1 (healthy participants) placebo, Part B2 (healthy Japanese participants) placebo |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: Part A: From screening (Day -28 to Day -2) to Day 10; Part B: From screening (Day -28 to Day-2) to Day 20
To assess the safety and tolerability of AZD4144 following oral administration of single and multiple ascending doses (Part A and Part B)
5 secondary outcomes
Maximum observed plasma (peak) drug concentration (Cmax)
Time frame: Part A: Day 1 to Day 4. and Day 10; Part B: Day 1 to Day 15 and Day 20
Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast)
Time frame: Part A: Day 1 to Day 4. and Day 10; Part B: Day 1 to Day 15 and Day 20
Area under plasma concentration-time curve from zero to infinity (AUC0-inf)
Time frame: Part A: Day 1 to Day 4. and Day 10; Part B: Day 1 to Day 15 and Day 20
Renal clearance of drug from plasma (CLR)
Time frame: Part A: Day 1 to Day 4. and Day 10; Part B: Day 1 to Day 15 and Day 20
PD analysis: Levels of disease-specific biomarkers
Time frame: Part A: Day 1 to Day 4 and Day 10; Part B: Day -1, Day 1 to Day 4, Day 12 to Day 15 and Day 20
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 13 Dec 2024.
- 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 and AZD4144 Part B 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 4 inclusion and 15 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 13 Dec 2024. 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) (time frame: Part A: From screening (Day -28 to Day -2) to Day 10; Part B: From screening (Day -28 to Day-2) to Day 20). 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 13 Dec 2024.