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Healthy VolunteersPhase 1NCT06544642

A Study to Evaluate the Effects of ASP5502 in Healthy Adults and Adults With Primary Sjögren's Syndrome

A Phase 1 study testing ASP5502 in people with Healthy Volunteers and Sjögren's Syndrome, run by Astellas Pharma Global Development, Inc. at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Primary Sjögren's syndrome (pSS) is a condition when the body's immune system attacks glands that produce fluids, such as the tear and saliva glands. This leads to dry eyes and a dry mouth. However, other symptoms may occur such as fatigue, joint pain, and skin problems. These symptoms can be severe. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers, Sjögren's Syndrome
What is being tested?
ASP5502
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
116 participants
Where
1 siteUnited States
Study dates
21 Aug 2024to 5 Mar 2026
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Participant is healthy and has no clinically significant medical conditions based on the review of the physical examination, ECG and protocol-defined clinical laboratory tests at screening or on day -2 or day -1.
  • Female participant is not pregnant and at least 1 of the following conditions apply:
  • Not a women of childbearing potential (WOCBP)
  • WOCBP who has a negative blood pregnancy test at screening and a urine pregnancy test on day -2 and agrees to follow the contraceptive guidance from the time of informed consent through at least 5 half-lives or 30 days, whichever is longer, after final study intervention administration. Female participants on hormonal contraceptives must also be using a double barrier method as defined in Contraceptive Requirements.
  • Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 5 half-lives or 30 days, whichever is longer, after final study intervention administration.
  • Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period and for 5 half-lives or 30 days, whichever is longer, after final study intervention administration.
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  • Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 5 half-lives or 30 days, whichever is longer, after final study intervention administration.
  • Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 5 half-lives or 30 days, whichever is longer, after final study intervention administration.
  • Male participant must not donate sperm during the treatment period and for 5 half-lives or 30 days, whichever is longer, after final study intervention administration.
  • Participant agrees not to participate in another interventional study while participating in the present study from the time of signing informed consent through the end of study visit.
  • Participant has a body mass index (BMI) range of 18.5 to 30.0 kg/m^2 inclusive and weighs at least 50 kg for male and 40 kg for female at screening.
  • Participant is diagnosed based on the 2016 American College of Rheumatology (ACR)- European Alliance of Associations for Rheumatology (EULAR) Classification Criteria for pSS. Diagnosis should have been established at least 6 months prior to day -1 and no clinically significant medical condition is present on the physical examination, ECG and protocol-defined clinical laboratory tests at screening or on day -1.
  • Female participant is not pregnant and at least 1 of the following conditions apply:
  • Not a WOCBP
  • WOCBP who has a negative blood pregnancy test at screening and a urine pregnancy test on day -1 and agrees to follow the contraceptive guidance from the time of informed consent through at least 5 half-lives or 30 days, whichever is longer, after final study intervention administration. Female participants on hormonal contraceptives are allowed ONLY if the participant also agrees to use a double barrier method (condom and spermicide) and the results from the 4β hydroxycholesterol assessment in Part 2 are negative.
  • WOCBP must also be using a double barrier method as defined in Contraceptive Requirements.
  • Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 5 half-lives or 30 days, whichever is longer, after final study intervention administration.
  • Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period and for 5 half-lives or 30 days, whichever is longer, after final study intervention administration.
  • Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 5 half-lives or 30 days, whichever is longer, after final study intervention administration.
  • Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 5 half-lives or 30 days, whichever is longer, after final study intervention administration.
  • Male participant must not donate sperm during the treatment period and for 5 half-lives or 30 days, whichever is longer, after final study intervention administration.
  • Participant agrees not to participate in another interventional study while participating in the present study from the time of signing informed consent through the end of study visit.
  • Participant has a BMI range of 18.5 to 30.0 kg/m^2 inclusive and weighs at least 50 kg for male and 40 kg for female at screening.

Who cannot join

  • Participant has been pregnant within 6 months prior to screening.
  • Participant has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy.
  • Participant has a history of malignancy within 2 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that is considered cured with minimal risk of recurrence).
  • Participant has had major surgery (e.g., requiring general anesthesia) within 90 days before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study or within 5 half-lives after the last dose of study intervention administration or end of study visit, whichever is longer.
  • Participant has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 28 days prior to day -1.
  • Participant has a positive QuantiFERON®-TB Gold test at screening.
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  • Participant has a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) criteria within 2 years before screening.
  • Participant has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, a family history of long QT syndrome or taking any QT prolonging medication.
  • Participant has used any prescribed or nonprescribed drugs (including vitamins and natural and herbal remedies, e.g., St. John's Wort) in the 28 days prior to study intervention administration, except for contraceptive use, hormone replacement therapy (HRT) use and occasional use of acetaminophen (up to 2 g/day).
  • Participant has used any inducer of metabolism (e.g., barbiturates and rifampin) in the 3 months prior to day -1.
  • Participant has received a vaccine within the 2 weeks prior to day -1 or will have a vaccine dose before the follow-up visit.
  • Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.
  • Participant has any of the liver safety monitoring panel (alkaline phosphatase [ALP], alanine transaminase [ALT], aspartate aminotransferase [AST] and total bilirubin [TBL]) above the upper limit of normal (ULN) on day -2. In such a case, the assessment may be repeated once.
  • Participant has creatinine level outside normal limits on day -2. In such a case, the assessment may be repeated once.
  • Participant has a mean pulse < 45 or > 90 bpm; mean systolic blood pressure > 140 mmHg; mean diastolic blood pressure > 90 mmHg (measurements taken in triplicate after participant has been resting in the supine position for at least 5 minutes; pulse will be measured automatically) on day -2. If the mean blood pressure exceeds the limits above, 1 additional triplicate may be taken.
  • Participant has a mean corrected QT interval using Fridericia's correction formula (QTcF) of > 430 msec (for male participants) and > 450 msec (for female participants) on day -2. If the mean QTcF exceeds these limits, 1 additional triplicate ECG may be taken.
  • Participant tests positive for alcohol at screening or on day -2.
  • Participant tests positive for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine and opiates) at screening or on day -2.
  • Participant tests positive for cannabinoids on day -2.
  • Participant has a positive rapid coronavirus disease (COVID) antigen test on day -2.
  • Participant has a positive serology test for hepatitis A virus (HAV) antibodies (immunoglobulin M [IgM]), hemoglobin C (HBc) antibodies, hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV) antibodies or antibodies to human immunodeficiency virus (HIV) type 1 and/or type 2 at screening.
  • Participant has any condition which makes the participant unsuitable for study participation.
  • Participant has a known or suspected hypersensitivity to ASP5502 or comparator or any components of the formulation used.
  • Participant has smoked, used tobacco-containing products or nicotine or nicotine-containing products (e.g., electronic vapes) within 6 months prior to screening or the participant tests positive for cotinine at screening or day -2.
  • Participant has a history of consuming > 10 units for male or > 8 units for female participants of alcoholic beverages per week within 3 months prior to screening (note: 1 unit = 12 ounces of beer, 5 ounces of wine, 1.5 ounce of spirits/hard liquor).
  • Participant has used any drugs of abuse (e.g., amphetamines, barbiturates, benzodiazepines, cocaine and/or opiates) within 3 months prior to day -1.
  • Participant has had significant blood loss, donated >/= 1 unit (450 mL) of whole blood or donated plasma within 7 days prior to day -1 and/or received a transfusion of any blood or blood products within 60 days.
  • Participant has had previous exposure with ASP5502.
  • Participant is an employee of Astellas, the study-related clinical research organizations (CROs) or the clinical unit.
  • Participant has been diagnosed with secondary Sjögren's syndrome or any other systemic autoimmune disease (e.g. rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis).
  • Participant has severe complications of Sjögren's syndrome, such as neurologic or cardiac involvement, interstitial lung disease and severe myositis.
  • Participant is using immunosuppressant therapy (e.g., methotrexate, azathioprine, mycophenolate mofetil), B-cell depleting agents (e.g., rituximab, belimimab), Janus kinase inhibitors (JAKi) (e.g., tofacitinib), calcineurin inhibitors (e.g., tacrolimus, cyclosporin), and other biologics (e.g., abatacept, cyclophosphamide, leflunomide).
  • Participant receives corticosteroid therapy exceeding 10 mg prednisone equivalents per day.
  • Participant has been pregnant within 6 months prior to screening.
  • Participant has any history or evidence of any not-related to pSS clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy.
  • Participant has a history of malignancy within 2 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that is considered cured with minimal risk of recurrence).
  • Participant has had major surgery (e.g., requiring general anesthesia) within 90 days before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study or within 5 half-lives after the last dose of study intervention administration or end of study visit, whichever is longer.
  • Participant has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 28 days prior to day -1.
  • Participant has a past history of serious opportunistic infections.
  • Participant has a positive QuantiFERON®-TB Gold test at screening.
  • Participant has a positive rapid COVID antigen test on day -1.
  • Participant has a history of drug or alcohol abuse according to DSM-5 criteria within 2 years before screening.
  • Participant has any of the liver safety monitoring panel (ALP, ALT, AST and TBL) above the ULN on day -1. In such a case, the assessment may be repeated once.
  • Participant has creatinine level outside normal limits on day -1. In such a case, the assessment may be repeated once.
  • Participant has a mean pulse < 45 or > 90 bpm; mean systolic blood pressure > 140 mmHg; mean diastolic blood pressure > 90 mmHg (measurements taken in triplicate after participant has been resting in the supine position for at least 5 minutes; pulse will be measured automatically) on day -1. If the mean blood pressure exceeds the limits above, 1 additional triplicate may be taken.
  • Participant has a mean corrected QTcF of > 450 msec on day -1.
  • Participant has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease or a family history of long QT syndrome.
  • Participant is using QT prolongating medication such as antiarrhythmics (e.g. amiodarone, sotalol, ibutilide, dofitilide, disopyramide), antipsychotic (e.g. chlorpromazine, haloperidol), antidepressants (e.g. citalopram), antibiotics (e.g. sparfloxacin, ciprofloxacin, erythromycin, azithromycin, clarithromycin) or antiemetics (e.g. domperidone).
  • Participant has used any Cytochrome P450 (CYP) 3A4 inducer of metabolism (e.g., barbiturates and phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant and products containing St. John's wort) or HIV protease inhibitors, HCV protease inhibitor or non-nucleoside reverse transcriptase inhibitors (e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, tipranavir/ritonavir, boceprevir, telaprevir and nevirapine) within 3 months prior to day -1.
  • Participant has used any narrow therapeutic index CYP3A4 substrate (e.g., alfentanil, cyclosporine, dihydroergotamine, ergotamine, everolimus, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus) within 24 hours prior to day -1.
  • Participant has received a vaccine within the 2 weeks prior to first study intervention administration or will have a vaccine dose before the follow-up visit.
  • Present or previous history of participation in a study of the study intervention.
  • Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.
  • Participant has any condition which makes the participant unsuitable for study participation.
  • Participant has a known or suspected hypersensitivity to ASP5502 or any components of the formulation used.
  • Participant is an employee of Astellas, the study-related clinical research organizations (CROs) or the clinical unit.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fortrea Clinical Research Unit Inc

    Daytona Beach, Florida, 32117

Other trials in United States

About this study

Official title: A Phase 1 Combined Single and Multiple Ascending Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Food Effect and Biomarker Response of ASP5502 in Healthy Adults and Participants With Primary Sjögren's Syndrome

Primary Sjögren's syndrome (pSS) is a condition when the body's immune system attacks glands that produce fluids, such as the tear and saliva glands. This leads to dry eyes and a dry mouth. However, other symptoms may occur such as fatigue, joint pain, and skin problems. These symptoms can be severe. Symptoms can be treated but there is an unmet need to treat the actual condition.

In this study, ASP5502 is being given to humans for the first time. The people taking part are healthy adults or adults with pSS. The main aims of the study are to check the safety of ASP5502 and how people tolerate ASP5502.

Read more

This study will be in 3 parts. In Part 1, healthy men and women will take tablets of ASP5502 or a placebo just once. In this study, the placebo looks like the ASP5502 tablet but doesn't have any medicine in it. Different small groups of people will take a lower to a higher dose of ASP5502 or a placebo. This will happen one group after another. One small group will take tablets of ASP5502 or placebo with and without food. This is to find out if food affects how the body processes ASP5502.

After their dose, people will stay in the medical center for a few nights. This is to have blood tests, electrocardiograms (ECGs) to check heart health, and other safety checks, and to report any medical problems. One of these checks is to have their heart continuously tracked during the first night. This is called telemetry. People who take tablets of ASP5502 or placebo with and without food will stay in the medical center for a few extra nights.

In Part 2, healthy men and women will take tablets of ASP5502 or a placebo. They will do this once a day for 2 weeks (14 days). Different small groups of people will take a lower to a higher dose of ASP5502 or a placebo. This will happen one group after another.

After taking ASP5502 or the placebo, people will stay in the medical center for a few nights. This is to have blood tests, ECGs to check heart health, and other safety checks, and to report any medical problems. Telemetry will also be done continuously during the first night.

In Part 3, men and women with pSS will take tablets of ASP5502. They will do this once a day for 4 weeks (28 days). Different small groups of people will take a lower to a higher dose of ASP5502. This will either happen for one group after another, or just for 1 group. The number of groups and the doses taken will be worked out from the results from Part 1 and Part 2 of this study. People will stay in the medical center for a couple of nights. This will happen for their first dose, then again after about 2 weeks and 4 weeks of treatment. As in Parts 1 and 2, this is to have blood tests, ECGs to check heart health, and other safety checks, and to report any medical problems.

In all parts of the study, people will return to the medical center about 1 week after their final blood sample is taken, for health check. People in parts 2 and 3 will also receive a telephone call safety check about 4 weeks after their last dose of ASP5502.

Read the detailed description

The study was terminated prior to enrolment into Part 3.

Being tested
ASP5502, Placebo
Keywords
ASP5502, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Food Effect
Medical subject headings
Sjogren's Syndrome

What participants receive

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

  • ASP5502Drug

    Oral

  • PlaceboDrug

    Oral

Study groups in NCT06544642
Study groupRoleWhat they receive
Part 1 - Single Ascending Dose in Healthy participants (Dose Escalation Cohort)ExperimentalParticipants will receive a single oral dose of ASP5502 or Placebo on Day 1.
Receives: Drug: ASP5502; Drug: Placebo
Part 1 - Single Ascending Dose in Healthy participants (Food Effect Cohort)ExperimentalParticipants will receive a single oral dose of ASP5502 or Placebo under fasting conditions on period 1 Day 1 and single dose of ASP5502 or Placebo under fed conditions on period 2 Day 1.
Receives: Drug: ASP5502; Drug: Placebo
Part 2 - Multiple Ascending Dose in Healthy participantsExperimentalParticipants will receive daily oral doses of ASP5502 or placebo for 14 days.
Receives: Drug: ASP5502; Drug: Placebo
Part 3 - Repeated Dose in Participants with pSSExperimentalParticipants will receive daily oral doses of ASP5502 for 28 days.
Receives: Drug: ASP5502

What is being measured

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

  1. Number of Participants With Adverse Events (AEs)

    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

    An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. This includes events related to the comparator, if applicable, and events related to the (study) procedures.

    Measured: Up to Day 58

  2. Number of participants with laboratory value abnormalities and/or AEs

    Number of participants with potentially clinically significant laboratory values.

    Measured: Up to Day 38

  3. Number of participants with vital sign abnormalities and/or AEs

    Number of participants with potentially clinically significant vital sign values.

    Measured: Up to Day 38

  4. Number of participants with 12-lead ECG abnormalities and/or AEs

    Number of participants with potentially clinically significant 12-lead ECG values.

    Measured: Up to Day 38

Secondary outcomes (7)

  1. Pharmacokinetics (PK) of ASP5502 in plasma: maximum concentration (Cmax)

    Cmax will be recorded from the PK plasma samples collected.

    Measured: Up to Day 29

  2. PK of ASP5502 in plasma: area under the concentration-time curve from the time of dosing to the last measurable concentration (AUClast) [Part 1]

    AUClast will be recorded from the PK plasma samples collected.

    Measured: Up to Day 7

  3. PK of ASP5502 in plasma: area under the concentration-time curve from the time of dosing extrapolated to time infinity (AUCinf) [Part 1]

    AUCinf will be recorded from the PK plasma samples collected.

    Measured: Up to Day 7

  4. PK of ASP5502 in plasma: area under the concentration-time curve from time of dosing to 24 hours post dose (AUC24) [Part 2 & Part 3]

    AUC24 will be recorded from the PK plasma samples collected.

    Measured: Up to Day 2

  5. PK of ASP5502 in plasma: area under the concentration-time curve during a dosing interval, where tau is the length of the dosing interval (AUCtau) [Part 2 & Part 3]

    AUCtau will be recorded from the PK plasma samples collected.

    Measured: Up to Day 29

  6. PK of ASP5502 in plasma: concentration immediately prior to dosing at multiple dosing (Ctrough) [Part 2 & Part 3]

    Ctrough will be recorded from the PK plasma samples collected.

    Measured: Up to Day 29

  7. Change from baseline in concentration-QT [Part 1 & Part 2]

    QT will be measured using ECG machine at site. Concentration will be recorded from PK plasma sample.

    Measured: Baseline up to Day 20

Timeline

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

  1. First posted9 Aug 2024
  2. Study start21 Aug 2024
  3. Primary completion5 Mar 2026
  4. Study completion5 Mar 2026

Why it stopped: Company's strategic decision

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
Basic science
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06544642
Sponsor's protocol ID
5502-CL-0001
Status last verified
Sep 2026
First submitted
6 Aug 2024
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ASP5502 in people with Healthy Volunteers and Sjögren's Syndrome, run by Astellas Pharma Global Development, Inc. 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 23 inclusion and 56 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: stopped early, as of the sponsor's last update on 14 Sep 2026. 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 was stopped early (reason given: Company's strategic decision). Results are not available in the source record.

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: Up to Day 58). 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?

On the ClinicalTrials.gov record for NCT06544642.

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 14 Sep 2026.

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