AzTrials
AzTrials

Idiopathic Pulmonary FibrosisPhase 1NCT05134727

Assess the Safety, Tolerability and Pharmacokinetics of AZD5055 Following Single and Multiple Ascending Doses in Healthy Participants

A Phase 1 study testing AZD5055 in people with Idiopathic Pulmonary Fibrosis, run by AstraZeneca at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a phase I, First-in-Human study in healthy participants, performed at a single study center, consisting of 2 parts: Part 1 is a single ascending dose (SAD) study and Part 2 is a multiple ascending dose (MAD) study. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Idiopathic Pulmonary Fibrosis
What is being tested?
AZD5055
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
63 participants
Where
1 siteUnited States
Study dates
18 Nov 2021to 31 Mar 2023
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

  • Healthy male and female (of non-childbearing potential) subjects aged Part 1 (SAD): 18 - 55 years; Part 2 (MAD): 18 - 55 for male and 18 -49 for females, inclusive, with suitable veins for cannulation or repeated venipuncture.
  • Female subjects must have a negative pregnancy test.
  • Have a BMI between 18 and 30 kg/m2 inclusive and weigh at least 50 kg.
  • Male subjects and their women of childbearing potential partners must be willing to use highly effective contraception measures and must refrain from donating sperm or fathering a child from the first day of dosing until 17 days after the last dose of Investigational medicinal product.

Who cannot join

  • History of any clinically important disease or disorder, or a major medical/surgical procedure or significant trauma within 4 weeks of the first dose of IMP.
  • Untreated tuberculosis (TB) or a positive result for the interferon gamma release assay (ie, QuantiFERON TB Gold).
  • A positive result for serum hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody, at the Screening Visit.
  • Ongoing acquired or inherited immunodeficiency disorders, including but not limited to HIV or common variable immunodeficiency, or the subject is taking immune replacement therapy.
  • Individuals with chronic infections (eg, urinary tract infection) or who are at increased risk of infection (eg, surgery, trauma, severe dental disease, or significant infection) within 30 days of screening.
  • History of severe COVID-19 infection requiring hospitalization within the last 12 months prior to Screening, or clinical history compatible with Long COVID 19 (symptoms beyond 12 weeks of acute infection).
Show all 29Show fewer
  • Confirmed COVID-19 infection during Screening and/or admission by reverse transcription polymerase chain reaction (RT-PCR) test. Subjects who previously had a positive test result during the screening visit or on Day-1 may be reconsidered for inclusion after they recover from the infection as confirmed by a negative retest before (re-)admission.
  • History of cancer within the last 10 years (20 years for breast cancer) except for basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix treated and considered cured. Any history of lymphoma is not allowed.
  • History of osteoporosis, osteomalacia, Paget's disease of the bone, thyrotoxicosis, rheumatoid arthritis, Cushing's disease, or a pathological fracture.
  • History of a traumatic fracture within 6 months of the Screening visit.
  • A Bone density scans (DEXA scan) bone mineral density value with T-score < -1 for post-menopausal women and Z score < -1.5 for male participants and premenopausal women of non-childbearing potential subjects (MAD cohorts only).
  • Has received live or live attenuated vaccine in the 30 days prior to dosing, the first dose of COVID-19 vaccine within 30 days prior to randomization, or a COVID 19 vaccine second or booster vaccination within 10 days of screening.
  • Ongoing acute gastrointestinal (GI) disease, a history of chronic GI disease, ongoing acute hepatic disease, or a history of chronic hepatic disease, chronic renal disease, pancreatic disease, diabetes mellitus, or any condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
  • History of Gilbert's syndrome.
  • History of muscle disease or rhabdomyolysis.
  • Any laboratory values with the deviations at the Screening Visit and/or Day -1 from the reference range.
  • Any clinically important abnormalities in clinical chemistry, hematology, or urinalysis.
  • Any clinically important abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically important abnormalities in the 12 lead ECG that may interfere with the interpretation of QTc interval changes, including abnormal ST wave morphology, particularly in the protocol defined primary lead or left ventricular hypertrophy.
  • Known or suspected history of drug abuse.
  • Current smokers who smoke > 5 cigarettes/e-cigarette/pipes per week or use of any tobacco in any other form.
  • History of alcohol abuse or excessive intake of alcohol within 6 months prior to screening.
  • Positive screen for drugs of abuse or alcohol at screening or admission.
  • History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
  • Plasma donation within 1 month of Screening or any blood donation/loss > 500 mL within 3 months of Screening.
  • Use of any prescribed or nonprescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), HRT (for females), herbal remedies, mega dose vitamins and minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long half life.
  • Use of drugs with enzyme inducing properties such as St John's Wort within 3 weeks prior to the first administration of IMP.
  • Excessive intake of high caffeine-containing drinks or food (eg, coffee, tea, energy drinks).
  • Has received another new chemical entity (defined as a compound that has not been approved for marketing) within 3 months of the first administration of IMP in this study.
  • Subjects who are vegans or have medical dietary restrictions.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Research Site

    Brooklyn, Maryland, 21225

Other trials in United States

About this study

Official title: A Double-blind, Randomized, Placebo-controlled Study in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of Oral AZD5055 Following Single and Multiple Ascending Doses

This is a phase I, First-in-Human study in healthy participants, performed at a single study center, consisting of 2 parts: Part 1 is a single ascending dose (SAD) study and Part 2 is a multiple ascending dose (MAD) study.

Read the detailed description

Part 1: This is a double-blind, randomized, placebo-controlled study consisting of 2 parts. Part 1: SAD and Part 2: MAD.

Part 1 will be a double-blind, randomized, placebo-controlled study, with a sequential SAD design. Three dose levels of AZD5055 are planned to be investigated in 3 cohorts. Depending on evaluation of data from the preceding cohorts, 2 additional cohorts/dose levels may be added at the discretion of the SRC.

Part 1 will comprise of:

  • A Screening Period of a maximum of 6 weeks.
  • A Treatment Period during which subjects will be resident at the Clinical Unit from 1 day before IMP administration (Day 1) until at least 72 hours after IMP administration (Day 4). Subjects will receive a single oral dose of AZD5055 or placebo on Day 1.
  • A Follow up Visit within 6 ± 1 day after the IMP dose.

Part 2 will be a double-blind, randomized, placebo-controlled study with a MAD design. Subjects will receive AZD5055 on Day 1 and Day 3 to Day 16, with no dosing on Day 2. Subjects will be naïve, ie, will not have participated in Part 1 of this study. Three dose levels of AZD5055 are planned to be investigated in 3 cohorts. Depending on evaluation of data of the preceding cohorts, up to 2 additional dose levels/cohorts may be added or expanded at the discretion of the SRC.

Part 2 will comprise of:

  • A Screening Period of a maximum of 6 weeks.
  • A treatment period with a dosing frequency (QD or BID) that will be dependent on emerging PK data from Part 1:
  1. For cohorts with QD dosing regimens:
  • A Treatment Period during which subjects will be resident at the Clinical Unit from 1 day before IMP administration (Day -1) until at least 72 hours after the last dose given on Day 16 (Day 19). Subjects will be dosed for a total of 15 days, receiving a single QD morning dose of AZD5055 or placebo on Day 1 and on Days 3 through Day 16.
  1. For cohorts with BID dosing regimens:
  • A Treatment Period during which subjects will be resident at the Clinical Unit from 1 day before IMP administration (Day -1) until at least 72 hours after the last dose given on Day 16 (Day 19). Subjects will be dosed for a total of 15 days, receiving a single morning dose of AZD5055 or placebo on Day 1 and Day 16, and repeated BID dosing on Day 3 through Day 15, 12 hours (± 30 minutes) apart.
  • A Follow-up Visit within 6 ± 1 day after the last IMP dose, and an additional Follow up Visit within 29 ± 2 days after the last IMP dose.
Being tested
AZD5055, Placebo
Keywords
AZD5055, Single ascending dose, Multiple ascending dose, Porcupine (PORCN) inhibitor, Healthy participants, Oral suspension
Medical subject headings
Idiopathic Pulmonary Fibrosis, Focal Dermal Hypoplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AZD5055Drug

    Healthy participants will receive AZD5055

  • PlaceboDrug

    Healthy participants will receive placebo

Study groups in NCT05134727
Study groupRoleWhat they receive
Part 1 (single ascending doses [SAD])ExperimentalHealthy participants will be randomized to a single dose of AZD5055 or placebo.
Receives: Drug: AZD5055; Drug: Placebo
Part 2 (multiple ascending doses [MAD])ExperimentalHealthy participants will be randomized to repeated dosing with AZD5055 or placebo
Receives: Drug: AZD5055; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Number of participants with adverse events (AEs)

    To investigate the safety and tolerability of AZD5055 by assessment of AEs (non-serious and serious) following administration of SAD

    Measured: Until Follow-up (7 days post dose) (approximately up to 53 days)

  2. Part 2: Number of participants with AEs

    To investigate the safety and tolerability of AZD5055 by assessment of AEs (non-serious and serious) following administration of MAD

    Measured: Until follow-up (45 days post-last dose) (approximately up to 89 days)

Secondary outcomes (31)

  1. Part 1: Maximum observed plasma (peak) drug concentration (Cmax)

    To characterize the PK of AZD5055 following oral administration of SAD to healthy participants

    Measured: Day 1: profile 0-72 hours after dose

  2. Part 2: Maximum observed plasma (peak) drug concentration (Cmax)

    To characterize the PK of AZD5055 following oral administration of MAD to healthy participants

    Measured: Day 1: profile 0-48 hours after dose, Day 16; profile 0-72 hours after dose

  3. Part 1: Area under plasma concentration time curve from zero to infinity (AUCinf)

    To characterize the PK of AZD5055 following oral administration of SAD to healthy participants

    Measured: Day 1: profile 0-72 hours after dose

  4. Part 2: Area under plasma concentration time curve from zero to infinity (AUCinf)

    To characterize the PK of AZD5055 following oral administration of MAD to healthy participants

    Measured: Day 1: profile 0-48 hours after dose

  5. Part 1: Area under the plasma concentration curve from zero to the last quantifiable concentration (AUClast)

    To characterize the PK of AZD5055 following oral administration of SAD to healthy participants

    Measured: Day 1: profile 0-72 hours after dose

  6. Part 2: Area under the plasma concentration curve from zero to the last quantifiable concentration (AUClast)

    To characterize the PK of AZD5055 following oral administration of MAD to healthy participants

    Measured: Day 1: profile 0-48 hours after dose, Day 16; profile 0-72 hours after dose

  7. Part 1: Time to reach maximum observed concentration (tmax)

    To characterize the PK of AZD5055 following oral administration of SAD to healthy participants

    Measured: Day 1: profile 0-72 hours after dose

  8. Part 2: Time to reach maximum observed concentration (tmax)

    To characterize the PK of AZD5055 following oral administration of MAD to healthy participants

    Measured: Day 1: profile 0-48 hours after dose, Day 16; profile 0-72 hours after dose

  9. Part 2: Area under plasma concentration-time curve in the dose interval (repeat dose only) (AUC[0-1τ])

    To characterize the PK of AZD5055 following oral administration of MAD to healthy participants

    Measured: Day 1: profile 0-48 hours after dose, Day 16; profile 0-72 hours after dose

  10. Part 1: Partial area under the plasma concentration-time curve from 0 to time 12 hours post dose [AUC(0-12)]

    To characterize the PK of AZD5055 following oral administration of SAD to healthy participants

    Measured: Day 1: profile 0-72 hours after dose

  11. Part 2: Partial area under the plasma concentration-time curve from 0 to time 12 hours post dose [AUC(0-12)]

    To characterize the PK of AZD5055 following oral administration of MAD to healthy participants

    Measured: Day 1: profile 0-48 hours after dose, Day 16; profile 0-72 hours after dose

  12. Part 1: Partial area under the plasma concentration-time curve from 0 to time 24 hours post dose [AUC(0-24)]

    To characterize the PK of AZD5055 following oral administration of SAD to healthy participants

    Measured: Day 1: profile 0-72 hours after dose

  13. Part 2: Partial area under the plasma concentration-time curve from 0 to time 24 hours post dose [AUC(0-24)]

    To characterize the PK of AZD5055 following oral administration of MAD to healthy participants

    Measured: Day 1: profile 0-48 hours after dose, Day 16; profile 0-72 hours after dose

  14. Part 1: Half-life associated with terminal slope (λz) of a semi logarithmic concentration-time curve (t½λz)

    To characterize the PK of AZD5055 following oral administration of SAD to healthy participants

    Measured: Day 1: profile 0-72 hours after dose

  15. Part 2: Half-life associated with terminal slope (λz) of a semi logarithmic concentration-time curve (t½λz)

    To characterize the PK of AZD5055 following oral administration of MAD to healthy participants

    Measured: Day 1: profile 0-48 hours after dose, Day 16; profile 0-72 hours after dose

  16. Part 1: Mean residence time of the unchanged drug in the systemic circulation (MRTinf)

    To characterize the PK of AZD5055 following oral administration of SAD to healthy participants

    Measured: Day 1: profile 0-72 hours after dose

  17. Part 2: Mean residence time of the unchanged drug in the systemic circulation (MRTinf)

    To characterize the PK of AZD5055 following oral administration of MAD to healthy participants

    Measured: Day 1: profile 0-48 hours after dose

  18. Part 1: Apparent total body clearance of drug from plasma after extravascular administration (CL/F)

    To characterize the PK of AZD5055 following oral administration of SAD to healthy participants

    Measured: Day 1: profile 0-72 hours after dose

  19. Part 2: Apparent total body clearance of drug from plasma after extravascular administration (CL/F)

    To characterize the PK of AZD5055 following oral administration of MAD to healthy participants

    Measured: Day 1: profile 0-48 hours after dose, Day 16; profile 0-72 hours after dose

  20. Part 1: Apparent volume of distribution following extravascular administration based on terminal phase (Vz/F)

    To characterize the PK of AZD5055 following oral administration of SAD to healthy participants

    Measured: Day 1: profile 0-72 hours after dose.

  21. Part 2: Apparent volume of distribution following extravascular administration based on terminal phase (Vz/F)

    To characterize the PK of AZD5055 following oral administration of MAD to healthy participants

    Measured: Day 1: profile 0-48 hours after dose, Day 16; profile 0-72 hours after dose

  22. Part 1: Cumulative amount of unchanged drug excreted into urine from time t1 to time t2 [Ae(t1-t2)]

    To characterize the PK of AZD5055 following oral administration of SAD to healthy participants

    Measured: Day 1: profile 0-72 hours after dose

  23. Part 2: Cumulative amount of unchanged drug excreted into urine from time t1 to time t2 [Ae(t1-t2)]

    To characterize the PK of AZD5055 following oral administration of MAD to healthy participants

    Measured: Day 1-3 and Day 16-19

  24. Part 1: Cumulative percentage of dose excreted unchanged in urine from time t1 to time t2 [fe(t1-t2)]

    To characterize the PK of AZD5055 following oral administration of SAD to healthy participants

    Measured: Day 1: profile 0-72 hours after dose

  25. Part 2: Cumulative percentage of dose excreted unchanged in urine from time t1 to time t2 [fe(t1-t2)]

    To characterize the PK of AZD5055 following oral administration of MAD to healthy participants

    Measured: Day 1-3 and Day 16-19

  26. Part 1: Renal clearance of drug from plasma (CLR)

    To characterize the PK of AZD5055 following oral administration of SAD to healthy participants

    Measured: Day 1: profile 0-72 hours after dose

  27. Part 2: Renal clearance of drug from plasma (CLR)

    To characterize the PK of AZD5055 following oral administration of MAD to healthy participants

    Measured: Day 1-3 and Day 16-19

  28. Part 1: Accumulation ratio (Rac)

    To characterize the PK of AZD5055 following oral administration of SAD to healthy participants

    Measured: Day 1: profile 0-72 hours after dose

  29. Part 2: Accumulation ratio (Rac)

    To characterize the PK of AZD5055 following oral administration of MAD to healthy participants

    Measured: Day 1: profile 0-48 hours after dose, Day 16; profile 0-72 hours after dose

  30. Part 1: Temporal change parameter in systemic exposure (TCP)

    To characterize the PK of AZD5055 following oral administration of SAD to healthy participants

    Measured: Day 1: profile 0-72 hours after dose

  31. Part 2: Temporal change parameter in systemic exposure (TCP)

    To characterize the PK of AZD5055 following oral administration of MAD to healthy participants

    Measured: Day 1: profile 0-48 hours after dose, Day 16; profile 0-72 hours after dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2021
  2. Study start18 Nov 2021
  3. Primary completion31 Mar 2023
  4. Study completion31 Mar 2023

Resources

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
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05134727
Sponsor's protocol ID
D8960C00001
Status last verified
May 2024
First submitted
15 Nov 2021
Last updated
16 May 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. 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AZD5055 in people with Idiopathic Pulmonary Fibrosis, run by AstraZeneca at 1 site 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 29 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 16 May 2024. 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 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. 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?

Part 1: Number of participants with adverse events (AEs) (time frame: Until Follow-up (7 days post dose) (approximately up to 53 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05134727.

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 16 May 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in