Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06544642
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
A Study to Evaluate the Effects of ASP5502 in Healthy Adults and Adults With Primary Sjögrens Syndrome
Sponsor:
None
Organization:
None
Study Overview
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 Sjögrens Syndrome
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Sjögrens syndrome pSS is a condition when the bodys 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 cope with 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 doesnt 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 a final health check
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 cope with 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 doesnt 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 a final health check
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None