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ASP5502 for Sjögren's Syndrome

Phase 1

Recruiting

Research Sponsored by Astellas Pharma Global Development, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy Participants: Participant has 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

Participants with pSS: Female participant must not be breastfeeding, donate ova, or participate in another interventional study

Must not have

Healthy Participants: Participant has/had febrile illness or infections within 28 days prior to day -1

Healthy Participants: Participant has history or evidence of clinically significant diseases or malignancies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to day 58

Summary

This trial is testing a new drug called ASP5502 for people with Primary Sjögren's syndrome. The drug is being tested on healthy adults and adults with the condition to see how safe it

Who is the study for?

This trial is for healthy adults and those with Primary Sjögren's Syndrome, a condition causing dry eyes and mouth due to immune system attacks on fluid-producing glands. Participants will be given ASP5502 or a placebo to assess the drug's safety and how well they tolerate it.

What is being tested?

ASP5502 is being tested in three parts: single-dose administration in healthy individuals, repeated doses over two weeks in another healthy group, and daily dosing for four weeks in people with pSS. The study aims to determine the optimal dosage and evaluate food effects on drug processing.

What are the potential side effects?

Potential side effects are not specified but may include reactions typical of new medications under investigation such as digestive discomfort, allergic reactions, or changes detected through blood tests, ECGs (heart health checks), or telemetry (continuous heart monitoring).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am healthy with a BMI between 18.5 and 30, and weigh at least 50 kg if male or 40 kg if female.

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I am not breastfeeding, donating eggs, or in another study.

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I am not pregnant and follow the required contraceptive guidelines.

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I am not breastfeeding, donating eggs, or in another study.

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I have been diagnosed with primary Sjögren's syndrome without any major health issues.

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I am a healthy male and will use birth control and not donate sperm.

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I have a BMI between 18.5 and 30, and I weigh at least 50 kg if male, or 40 kg if female.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had a fever or infection in the last 28 days.

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I have no history of significant diseases or cancers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 58

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 58

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 58 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Adverse Events (AEs)

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

Number of participants with laboratory value abnormalities and/or AEs

+1 more

Secondary study objectives

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

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]

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

+4 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Part 3 - Repeated Dose in Participants with pSSExperimental Treatment1 Intervention

Participants will receive daily oral doses of ASP5502 for 28 days.

Group II: Part 2 - Multiple Ascending Dose in Healthy participantsExperimental Treatment2 Interventions

Participants will receive daily oral doses of ASP5502 or placebo for 14 days.

Group III: Part 1 - Single Ascending Dose in Healthy participants (Food Effect Cohort)Experimental Treatment2 Interventions

Participants 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.

Group IV: Part 1 - Single Ascending Dose in Healthy participants (Dose Escalation Cohort)Experimental Treatment2 Interventions

Participants will receive a single oral dose of ASP5502 or Placebo on Day 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

0 / 9Eligibility criteria met