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NCT06544642 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Effects of ASP5502 in Healthy Adults and Adults With Primary Sjögren's Syndrome
A Phase 1 study of Healthy Volunteers and Sjögren's Syndrome, sponsored by Astellas Pharma Global Development.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 132
- Enrollment target
- 1
- Study location
NCT06544642 is a Phase 1 study of Healthy Volunteers and Sjögren's Syndrome that is actively recruiting participants, run by Astellas Pharma Global Development. The registered enrollment target is 132 participants, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06544642, a Phase 1 study of Healthy Volunteers and Sjögren's Syndrome, is actively recruiting participants, sponsored by Astellas Pharma Global Development.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 132 participants
- Enrollment target
- 1
- Study location
Study 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. 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. 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, an
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ASP5502
Study Locations (1)
Florida
- Fortrea Clinical Research Unit Inc - Daytona Beach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2024-08-21 |
| Est. Completion | 2027-07-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06544642
The ClinicalTrials.gov registry entry for NCT06544642 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (73% lower). The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06544642 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT06544642 about?
NCT06544642 is a clinical study titled "A Study to Evaluate the Effects of ASP5502 in Healthy Adults and Adults 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...
What is the current status of trial NCT06544642?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 132 participants. The study started on 2024-08-21. Estimated completion is 2027-07-31.
What conditions does trial NCT06544642 study?
This clinical trial studies the following conditions: Healthy Volunteers, Sjögren's Syndrome.
What interventions are being tested in trial NCT06544642?
The interventions under investigation include: Placebo (DRUG), ASP5502 (DRUG).
Who is sponsoring clinical trial NCT06544642?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06544642 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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