Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06628206
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase 1b Randomized Double Blind Placebo-controlled Study to Evaluate Safety Tolerability and Pharmacokinetics of LPX-TI641 in Patients with Rheumatoid Arthritis and Psoriatic Arthritis
Status:
NOT_YET_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:
The goal of this clinical trial is to study the drug LPX-TI641 in patients with rheumatoid arthritis and psoriatic arthritis We will compare the safety and tolerability of LPX-TI641 to placebo a look-alike solution that contains no drug We will also evaluate the plasma pharmacokinetics of LPX-TI641 LPX-TI641 or placebo will be administered as an oral solution for 28 days
Detailed Description:
This is a Phase 1b multi-center randomized double-blind parallel-group placebo-controlled multiple dose study in participants with rheumatological conditions rheumatoid arthritis psoriatic arthritis
There will be 2 cohorts one for each indication Each cohort will consist of 15-25 participants Total up to 50 participants
The Primary objective of the study is to evaluate the safety and tolerability after multiple oral doses of LPX-TI641 in participants with RA and PsA
And the secondary objective of the study is to evaluate the plasma pharmacokinetics after multiple oral doses of LPX-TI641 in participants with RA and PsA
There will be 2 cohorts one for each indication Each cohort will consist of 15-25 participants Total up to 50 participants
The Primary objective of the study is to evaluate the safety and tolerability after multiple oral doses of LPX-TI641 in participants with RA and PsA
And the secondary objective of the study is to evaluate the plasma pharmacokinetics after multiple oral doses of LPX-TI641 in participants with RA and PsA
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