Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06619990
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Randomized Double-Blind Placebo-Controlled Study in Healthy Participants Followed by a Randomized Double-Blind Placebo-Controlled Phase 2 Study in Participants With Moderate-To-Severe Active Ulcerative Colitis
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:
Brief summary The Phase 1 study described herein will evaluate the safety tolerability pharmacokinetics and pharmacodynamics of XmAb942 in healthy volunteers Parts A and B Part C of this study will be a Phase 2 study to evaluate XmAb942 in participants with Ulcerative Colitis
Detailed Description:
This study is a Phase 1 randomized double-blind placebo-controlled single ascending dose SAD study in healthy volunteers followed by a cohort of three repeating doses in healthy volunteers The third part of this study will be a Phase 2 randomized placebo controlled double blind evaluation of participants with Ulcerative Colitis with a dose determined from Parts A and B
This study consists of 3 parts as follows
Part A SAD in healthy participants will entail administration of XmAb942 or matching placebo
Part B Repeat Dosing for up to 3 doses will entail administration of XmAb942 or matching placebo
Part C Participants with UC to receive XmAb942 or placebo with dose determined from Part A and Part B
This study consists of 3 parts as follows
Part A SAD in healthy participants will entail administration of XmAb942 or matching placebo
Part B Repeat Dosing for up to 3 doses will entail administration of XmAb942 or matching placebo
Part C Participants with UC to receive XmAb942 or placebo with dose determined from Part A and Part B
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