XmAb942 for Ulcerative Colitis

Recruiting at 5 trial locations

Overseen By Mark Osterman, MD, MSCE

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: GALE Therapeutics Inc.

Compensation: Varies

Number of Visits: Unknown

270 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 (UC).

Who Is on the Research Team?

Mark Osterman, MD, MSCE

Principal Investigator

Xencor, Inc.

Are You a Good Fit for This Trial?

This trial is for healthy adults with a BMI of 18-35 and those with ulcerative colitis. Participants must have normal lab values, be aged 18-55, and use contraception. It's not suitable for individuals with significant medical history or conditions that could interfere with the study.

Inclusion Criteria

I am eligible for both parts A and B of the study.

I am in good health with no major medical issues.

My blood tests are within normal limits.

What Are the Treatments Tested in This Trial?

Interventions

• XmAb942

Trial Overview The study tests XmAb942 in two groups: healthy volunteers (Parts A & B) to assess safety and dosage, followed by people with ulcerative colitis (Part C) to evaluate its effectiveness in treating their condition compared to a placebo.

How Is the Trial Designed?

Group I: Part C: Active Active Control 1 Intervention

Active XmAb942 to be administered to participants with moderately to severely active Ulcerative Colitis

Group II: Part A: Active drug Active Control 1 Intervention

Active XmAb942 to be administered to healthy volunteers. Single administration of 3 ascending dose (SAD) levels of XmAb942 via SC (3 cohorts) or IV (3 cohorts) administration in 8 participants per cohort, randomized in a 3:1 ratio to active or placebo.

Group III: Part B: Active Active Control 1 Intervention

Active XmAb942 to be administered to healthy volunteers. Multiple administrations of 2 ascending dose (MAD) levels of XmAb942 via IV administration in 8 participants per cohort, randomized in a 3:1 ratio to active or placebo.

Group IV: Part B: Placebo Placebo Group 1 Intervention

Placebo Comparator to be administered to healthy volunteers. Multiple administrations of 2 ascending dose (MAD) levels will be randomized in a 3:1 ratio to active or placebo.

Group V: Part C: placebo Placebo Group 1 Intervention

Placebo comparator to be administered to participants with moderately to severely active Ulcerative Colitis

Group VI: Part A: Placebo Placebo Group 1 Intervention

Placebo Comparator to be administered to healthy volunteers. Single administration of 3 ascending dose (SAD) levels will be randomized in a 3:1 ratio to active or placebo.

Who Is Running the Clinical Trial?

GALE Therapeutics Inc.

Lead Sponsor

Trials

1

Recruited

300+

Xencor, Inc.

Lead Sponsor

Trials

31

Recruited

2,500+