Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06260527
Status:
COMPLETED
Last Update Posted:
2024-02-15
First Post:
2024-01-29
Brief Title:
Safety and Pharmacokinetic Study of ARTS-011 in Chinese Healthy Volunteers
Sponsor:
Allorion Therapeutics Inc
Organization:
Allorion Therapeutics Inc
Study Overview
Official Title:
A Phase 1 Randomized Double-blind Third-party Open Placebo-controlled Study To Evaluate The Safety Tolerability Pharmacokinetics And Food Effect After Single and Multiple Oral Doses of ARTS-011 In Chinese Health Subjects
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This single- and multiple-ascending dose study is a Phase 1 first in human study of ARTS-011 The goal of the study is to assess the safety tolerability pharmacokinetics pharmacodynamics and food effect of ARTS-011 after single and multiple oral doses of ARTS-011 in Chinese healthy volunteers
Detailed Description:
ARTS-011 is an oral potent Tyrosine kinase 2 TYK2 inhibitor with a good selectivity profile over other human kinase TYK2 is required for signal transduction and cellular functions downstream of interferons IFN IL-23 and IL-12 which are involved in the initiation and pathogenesis of psoriatic diseases ARTS-011 is being developed for treatment of moderate-severe psoriasis and other autoimmune diseases
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None