Ignite Creation Date:
2024-05-06 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05743010
Status:
RECRUITING
Last Update Posted:
2023-09-06
First Post:
2022-11-15
Brief Title:
A Phase 1b Study to Evaluate APL-1401 in Patients With Moderately to Severely Active Ulcerative Colitis
Sponsor:
Jiangsu Yahong Meditech Co Ltd aka Asieris
Organization:
Jiangsu Yahong Meditech Co Ltd aka Asieris
Study Overview
Official Title:
A Phase 1b Randomized Double-blind Study to Evaluate the Safety Tolerability Pharmacokinetics and Preliminary Efficacy of APL-1401 in Patients With Moderately to Severely Active Ulcerative Colitis
Status:
RECRUITING
Status Verified Date:
2023-01
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 is a randomized double-blind placebo-controlled phase 1b study designed to evaluate safety tolerability PK and preliminary efficacy of APL-1401 in patients with moderately to severely active UC This study comprises 3 periods including screening period D-28D-1 treatment period D1-D28 and safety follow-up periodD29-D58
Detailed Description:
On Day 1 patients who meet all entry criteria and none of the exclusion criteria will be randomized to receive either APL-1401 or placebo in a 51 ratio Patients will receive APL-1401 orally once daily QD during the 28-day treatment period
Three cohorts with increasing doses of APL-1401 will be explored The dose of APL-1401 will start at 120 mg QD in Cohort 1 and sequentially increase to 160 mg QD and 200 mg QD in Cohort 2 and Cohort 3 respectively Three cohorts with increasing doses of APL-1401 will be explored 200mg QD is designed to be maximum dose in this study
In one cohort if dose stopping criteria of cohort is not met Safety Monitoring Committee SMC will be held when last patient completes 28-day of study treatment SMC will determine whether to continue the study to next cohort base on pre-defined dose escalation criteria safety data and available PK data At this dose strength if patients are well tolerated and SMC decides to escalate to a higher dose the next cohort will be started
Three cohorts with increasing doses of APL-1401 will be explored The dose of APL-1401 will start at 120 mg QD in Cohort 1 and sequentially increase to 160 mg QD and 200 mg QD in Cohort 2 and Cohort 3 respectively Three cohorts with increasing doses of APL-1401 will be explored 200mg QD is designed to be maximum dose in this study
In one cohort if dose stopping criteria of cohort is not met Safety Monitoring Committee SMC will be held when last patient completes 28-day of study treatment SMC will determine whether to continue the study to next cohort base on pre-defined dose escalation criteria safety data and available PK data At this dose strength if patients are well tolerated and SMC decides to escalate to a higher dose the next cohort will be started
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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